Cost of out-of-hospital cardiac arrest survivors compared with matched control groups.

INTRODUCTION: Societal costs of out-of-hospital cardiac arrest (OHCA) survivors may be extensive due to high health care utilization and sick leave. Knowledge of the costs of OHCA survivors may guide decision-makers to prioritize health resources. AIM: The aims of the study were to evaluate the costs of OHCA survivors from a societal perspective, and to compare these costs to the costs of individuals with non-cardiac arrest myocardial infarction (MI) and individuals with no cardiac disease (non-CD). METHODS: From the Danish OHCA Registers, survivors, with a cardiac arrest between 2005-2018 were identified. Each case was assigned one MI control and one non-CD control, matched on gender and age. Based on register data, costs of healthcare utilization, sick leave, vocational rehabilitation, disability pension and other social benefits one year before event and five years after, were estimated. RESULTS: In total 5,646 OHCA survivors were identified with associated control groups. The mean costs for OHCA survivors during the 6-year period were €119,106 (95%CI: 116,297-121,916), with €83,472 (95%CI: 81,392-85,552) being healthcare costs. Mean costs of OHCA survivors were €49,132 higher than the MI-control group and €100,583 higher than the non-CD control group. CONCLUSIONS: Total costs of OHCA survivors were considerably higher than costs of MI- and non-CD controls. Hospital costs were highest during the first year after event, and work inability during the second to fifth year with sick leave and later disability pension as main burdens.

Cryoneurolysis versus radiofrequency ablation outcome on pain experience in chronic low back pain (COPE): a single-blinded randomised controlled trial.

OBJECTIVE: A comparison of cryoneurolysis or radio frequency (RF) with placebo in patients with facetogenic chronic low back pain (LBP) for patient global impression of change (PGIC), pain intensity, function and quality of life, with 1-year follow-up. DESIGN: Single-centre, single-blinded placebo-controlled randomised controlled trial. SETTING: Single-centre study. PARTICIPANTS: Inclusion from March 2020 to September 2022: consenting adults over 18 years of age, LBP>3 months, average Numeric Rating Scale LBP≥4 average last 14 days and a positive response to a diagnostic medial branch block (>50% pain reduction after 60 min). INTERVENTIONS: 120 patients were block randomised 1:1:1 to cryoneurolysis, RF or placebo of the medial branch nerves. Physical therapy was added after 4 weeks for all groups. MAIN OUTCOME MEASURES: Primary outcome was PGIC 4 weeks after the intervention. Secondary outcomes included pain intensity (Numeric Rating Scale, NRS), quality of life (Short Form 36, EQ-5D-5L), disability (Oswestry Disability Index), depression (Major Depression Inventory) and catastrophising (Pain Catastrophising Scale). Outcomes were measured at 4 weeks, 3, 6 and 12 months. RESULTS: There was no statistically significant difference in PGIC at 4 weeks between cryoneurolysis and placebo (risk ratio (RR) 2; 95% CI 0.75 to 5.33, p=0.17) and RF and placebo (RR 1.6; 95% CI 0.57 to 4.49, p=0.37), except PGIC for cryoneurolysis at 6-month follow-up (RR 5.1; 95% CI 1.20 to 22.03, p=0.03). No statistically significant differences were found in secondary follow-up endpoints. CONCLUSIONS: Denervation of the medial branch nerve by either cryoneurolysis or RF compared with placebo did not demonstrate significant improvement in PGIC, pain intensity, function and quality of life in patients with facetogenic chronic LBP at short-term or long-term follow-up. TRIAL REGISTRATION NUMBER: NCT04786145.

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.

Predicting direct healthcare costs of general practitioner-guided care in patients with musculoskeletal complaints.

ABSTRACT: Information on healthcare utilization and costs of general practitioner (GP)-guided care in patients with musculoskeletal complaints is important for keeping healthcare affordable and accessible. A registry-based study was performed to describe healthcare utilization and costs of GP-guided care in patients with musculoskeletal complaints and to predict having higher direct healthcare costs. Healthcare costs of GP-guided care included all healthcare resources used by patients due to a musculoskeletal condition in 2018. Data were extracted from the database with a 1-year follow-up and descriptively analyzed. A general linear model was developed to predict having higher direct healthcare costs. In total, 403,719 patients were included, of whom 92% only received a single consultation. The number of referrals varied across the different types of complaints. Total annual direct healthcare costs amounted to €39,180,531, of which a key cost driver was referrals. Primary care consultations accounted for the largest part of referral-related costs. For all musculoskeletal conditions combined, the mean annual direct healthcare cost per patient was €97 (SEM = €0.18). Older age, being a woman, low socioeconomic status, spine complaints, high number of musculoskeletal diagnoses, and a high comorbidity score were predictive of having higher direct healthcare costs and explained 0.7% of the variance. This study showed that mean annual direct healthcare costs of GP-guided care in patients with musculoskeletal conditions were relatively low and did not differ considerably across conditions. The predictive model explained a negligible part of the variance in costs. Thus, it is unclear which factors do predict high direct healthcare costs in this population.

Six-month cost-effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management for workers with musculoskeletal disorders: the MI-NAV economic evaluation.

OBJECTIVES: This study evaluates the six-month cost-effectiveness and cost-benefits of motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) added to usual case management (UC) for workers on sick leave due to musculoskeletal disorders. METHODS: This study was conducted alongside a three-arm RCT including 514 employed workers on sick leave for at least 50% for ≥ 7 weeks. All participants received UC. The UC + MI group received two MI sessions, and the UC + SVAI group received 1-4 SVAI sessions. Sickness absence days, quality-adjusted life-years (QALYs), and societal costs were measured between baseline and six months. RESULTS: Adding MI to UC, resulted in incremental cost-reduction of -2580EUR (95%CI -5687;612), and a reduction in QALYs of -0.001 (95%CI -0.02;0.01). Secondly, adding MI to UC resulted in an incremental cost-reduction of -538EUR (95%CI -1358;352), and reduction of 5.08 (95%CI -3.3;13.5) sickness-absence days. Financial return estimates were positive, but not statistically significant. Adding SVAI to UC, resulted in an incremental cost-reduction of -2899 EUR (95% CI -5840;18), and a reduction in QALYs of 0.002 (95% CI -0.02;0.01). Secondly, adding SVAI to UC resulted in an statistically significant incremental cost-reduction of -695 EUR (95% CI -1459;-3), and a reduction of 7.9 (95% CI -0.04;15.9) sickness absence days. Financial return estimates were positive and statistically significant. The probabilities of cost-effectiveness for QALYs were high for adding MI or SVAI (ceiling ratio 0.90). CONCLUSIONS: In comparison to UC only, adding MI to UC tends to be cost-effective. Adding SVAI to UC is cost-effective for workers on sick leave due to musculoskeletal disorders. TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03871712).

Red flags to screen for vertebral fracture in patients presenting with low-back pain.

EDITORIAL NOTE: See https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD014461.pub2/full for a more recent review that covers this topic and has superseded this review. BACKGROUND: Low-back pain (LBP) is a common condition seen in primary care. A principal aim during a clinical examination is to identify patients with a higher likelihood of underlying serious pathology, such as vertebral fracture, who may require additional investigation and specific treatment. All 'evidence-based' clinical practice guidelines recommend the use of red flags to screen for serious causes of back pain. However, it remains unclear if the diagnostic accuracy of red flags is sufficient to support this recommendation. OBJECTIVES: To assess the diagnostic accuracy of red flags obtained in a clinical history or physical examination to screen for vertebral fracture in patients presenting with LBP. SEARCH METHODS: Electronic databases were searched for primary studies between the earliest date and 7 March 2012. Forward and backward citation searching of eligible studies was also conducted. SELECTION CRITERIA: Studies were considered if they compared the results of any aspect of the history or test conducted in the physical examination of patients presenting for LBP or examination of the lumbar spine, with a reference standard (diagnostic imaging). The selection criteria were independently applied by two review authors. DATA COLLECTION AND ANALYSIS: Three review authors independently conducted 'Risk of bias' assessment and data extraction. Risk of bias was assessed using the 11-item QUADAS tool. Characteristics of studies, patients, index tests and reference standards were extracted. Where available, raw data were used to calculate sensitivity and specificity with 95% confidence intervals (CI). Due to the heterogeneity of studies and tests, statistical pooling was not appropriate and the analysis for the review was descriptive only. Likelihood ratios for each test were calculated and used as an indication of clinical usefulness. MAIN RESULTS: Eight studies set in primary (four), secondary (one) and tertiary care (accident and emergency = three) were included in the review. Overall, the risk of bias of studies was moderate with high risk of selection and verification bias the predominant flaws. Reporting of index and reference tests was poor. The prevalence of vertebral fracture in accident and emergency settings ranged from 6.5% to 11% and in primary care from 0.7% to 4.5%. There were 29 groups of index tests investigated however, only two featured in more than two studies. Descriptive analyses revealed that three red flags in primary care were potentially useful with meaningful positive likelihood ratios (LR+) but mostly imprecise estimates (significant trauma, older age, corticosteroid use; LR+ point estimate ranging 3.42 to 12.85, 3.69 to 9.39, 3.97 to 48.50 respectively). One red flag in tertiary care appeared informative (contusion/abrasion; LR+ 31.09, 95% CI 18.25 to 52.96). The results of combined tests appeared more informative than individual red flags with LR+ estimates generally greater in magnitude and precision. AUTHORS' CONCLUSIONS: The available evidence does not support the use of many red flags to specifically screen for vertebral fracture in patients presenting for LBP. Based on evidence from single studies, few individual red flags appear informative as most have poor diagnostic accuracy as indicated by imprecise estimates of likelihood ratios. When combinations of red flags were used the performance appeared to improve. From the limited evidence, the findings give rise to a weak recommendation that a combination of a small subset of red flags may be useful to screen for vertebral fracture. It should also be noted that many red flags have high false positive rates; and if acted upon uncritically there would be consequences for the cost of management and outcomes of patients with LBP. Further research should focus on appropriate sets of red flags and adequate reporting of both index and reference tests.

The care pathway of individuals with spinal disorders in a Health Care Network in the Federal District, Brazil: a retrospective study.

BACKGROUND: Understanding the care pathway is essential to identify how to effectively treat spinal disorders. However, there is no specific data on the pathway of these individuals in the Health Care Networks (HCN) in Brazil. OBJECTIVE: To investigate the pathway of individuals with non-specific spinal disorders (NSD) in the HCN in the Federal District, Brazil, and verify the interventions adopted, and to test whether sociodemographic and clinical variables predict the number of imaging tests, prescribed medication, and the first HCN access. METHODS: Retrospective study that analysed electronic records of 327 individuals with NSD between 2012 and 2018. Generalized linear models estimated the association between sociodemographic and clinical data and number of drugs prescribed and imaging tests requested. Multinomial logistic regression estimated the association between clinical and demographic variables and setting of first access. RESULTS: The median age was 57 years, and 75.5% were women. Emergency Department (ED) was the most accessed setting (43.7%), and back pain was the most prevalent condition (84.5%). Most individuals underwent imaging tests (60%) and drug prescriptions (86%). Physical exercises were prescribed to 13%, and 55% were referred to physical therapy. Women were more likely to first access the ED. CONCLUSION: The ED was the most used setting by people with NSD. Few participants received exercise prescriptions and half were referred to physical therapists. Individuals who used outpatient clinics and primary care received less drug prescriptions, and women were more likely to first access the ED. Increasing age was associated with greater chance of first accessing Outpatient Clinics.

Measurement properties of performance-based instruments for assessing mental function during activity and participation in persons with stroke: A systematic review.

BACKGROUND: Various performance-based instruments exist to assess mental function after stroke and users have to select one for research or clinical practice. OBJECTIVES: To evaluate the measurement properties of performance-based instruments to assess (any aspect of) mental function during activity and participation in persons after stroke. MATERIAL AND METHODS: We searched in five electronic databases. COSMIN methodology was used to conduct the review. The strength of evidence was assessed using a modified GRADE approach. RESULTS: Fifty articles were included reporting on 20 instruments assessing (1) multiple mental functions including ≥ four subdomains (2) attention, memory and executive functions, or single subdomains (3) executive functions, (4) perception, and (5) mental function of language. Highest quality evidence for sufficient results was found for some measurement properties in seven instruments. These instruments included: FIM + FAM, MPAI-4 and EFPT, MET, CBS/KF-NAP, BIT and the Scenario Test. CONCLUSIONS: Further studies of high methodological quality are needed that evaluate the measurement properties of instruments to allow clinicians and researchers to select the most suitable performance-based measures for purpose. SIGNIFICANCE: Results may be used to select the most suitable performance-based instrument to measure mental function during activity and participation in persons with stroke. TRIAL REGISTRATION NUMBER: PROSPERO CRD42018086744.

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).

Effectiveness of a Lifestyle Intervention for People With a Severe Mental Illness in Dutch Outpatient Mental Health Care: A Randomized Clinical Trial.

Importance: People with a severe mental illness (SMI) have a life expectancy reduced by 10 to 20 years compared with the general population, primarily attributable to cardiometabolic disorders. Lifestyle interventions for people with SMI can improve health and reduce cardiometabolic risk. Objective: To evaluate the effectiveness of a group-based lifestyle intervention among people with SMI in outpatient treatment settings compared with treatment as usual (TAU). Design, Setting, and Participants: The Severe Mental Illness Lifestyle Evaluation (SMILE) study is a pragmatic cluster randomized clinical trial performed in 8 mental health care centers with 21 flexible assertive community treatment teams in the Netherlands. Inclusion criteria were SMI, age of 18 years or older, and body mass index (calculated as weight in kilograms divided by height in meters squared) of 27 or greater. Data were collected from January 2018 to February 2020, and data were analyzed from September 2020 to February 2023. Interventions: Weekly 2-hour group sessions for 6 months followed by monthly 2-hour group sessions for another 6 months, delivered by trained mental health care workers. The intervention targeted overall lifestyle changes, emphasizing establishing a healthy diet and promoting physical activity. TAU (control) did not include structured interventions or advice on lifestyle. Main Outcomes and Measures: Crude and adjusted linear mixed models and multivariable logistic regression analyses were performed. The main outcome was body weight change. Secondary outcomes included changes in body mass index, blood pressure, lipid profiles, fasting glucose level, quality of life, self-management ability, and lifestyle behaviors (physical activity and health, mental health, nutrition, and sleep). Results: The study population included 11 lifestyle intervention teams (126 participants) and 10 TAU teams (98 participants). Of 224 included patients, 137 (61.2%) were female, and the mean (SD) age was 47.6 (11.1) years. From baseline to 12 months, participants in the lifestyle intervention group lost 3.3 kg (95% CI, -6.2 to -0.4) more than those in the control group. In the lifestyle intervention group, people with high attendance rates lost more weight than participants with medium and low rates (mean [SD] weight loss: high, -4.9 [8.1] kg; medium, -0.2 [7.8] kg; low, 0.8 [8.3] kg). Only small or no changes were found for secondary outcomes. Conclusions and Relevance: In this trial, the lifestyle intervention significantly reduced weight from baseline to 12 months in overweight and obese adults with SMI. Tailoring lifestyle interventions and increasing attendance rates might be beneficial for people with SMI. Trial Registration: Netherlands Trial Register Identifier: NTR6837.

Prognostic factors for high societal costs: a register-based study on 561,665 patients with shoulder disorders.

ABSTRACT: Shoulder disorders are common and associated with high societal costs, especially for a small group of patients. Prognostic factors can help identify high-cost patients, which is crucial to optimize early identification and develop tailored interventions. We aimed to identify prognostic factors for high societal costs, to examine whether the prognostic factors were similar for high healthcare costs and high costs of sick leave, and to investigate the model's robustness across 4 diagnostic categories. Using national Danish registers, potential prognostic factors (age, sex, educational level, long-term sick leave, admission, visits to general practitioner and physiotherapist, comorbidity, diabetes, low back pain, and neck pain) were included in a logistic regression model with high societal costs, defined by the top 10th percentile, as the main outcome. The model's prognostic accuracy was assessed using the Nagelkerke R2 and its discriminative ability using area under the receiver operating curve (AUC). Data on 80% of the patients (n = 449,302) were used to develop the model and 20% (n = 112,363) to validate the model. By far the strongest prognostic factor for high societal costs and high costs of sick leave was sick leave at the time of diagnosis (OR: 20.2, 95% CI: 19.5-20.9). Prognostic factors for high healthcare costs were high age, comorbidity, and hospital admission the year before diagnosis. The model was robust across diagnostic categories and sensitivity analyses. In the validation sample, the primary model's discriminative ability was good (AUC = 0.80) and the model explained 28% of the variation in the outcome (Nagelkerke R2 ).

The McKenzie method for (sub)acute non-specific low back pain.

BACKGROUND: There is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment). OBJECTIVES: To evaluate the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and two trials registers up to 15 August 2022. SELECTION CRITERIA: We included randomized controlled trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: This review included five RCTs with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events. McKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention - main comparison) There is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.3, 95% CI -12.0 to -2.56; 2 trials, 377 participants) but not in the intermediate term (MD -5.0, 95% CI -14.3 to 4.3; 1 trial, 180 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.5, 95% CI -7.5 to 2.0; 2 trials, 328 participants) nor in the intermediate term (MD -0.9, 95% CI -7.3 to 5.6; 1 trial, 180 participants). McKenzie method versus manual therapy There is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.7, 95% CI -27.4 to 10.0; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.0, 95% CI 0.7 to 13.3; 1 trial, 235 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -5.0, 95% CI -15.0 to 5.0; 3 trials, 298 participants) nor in the intermediate term (MD 4.3, 95% CI -0.7 to 9.3; 1 trial, 235 participants). McKenzie method versus other interventions (massage and advice) There is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.0, 95% CI -15.4 to 23.4; 1 trial, 30 participants) nor in the intermediate term (MD 10.0, 95% CI -8.9 to 28.9; 1 trial, 30 participants). AUTHORS' CONCLUSIONS: Based on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.

Pharmacological treatments for low back pain in adults: an overview of Cochrane Reviews.

BACKGROUND: Pharmacological interventions are the most used treatment for low back pain (LBP). Use of evidence from systematic reviews of the effects of pharmacological interventions for LBP published in the Cochrane Library, is limited by lack of a comprehensive overview. OBJECTIVES: To summarise the evidence from Cochrane Reviews of the efficacy, effectiveness, and safety of systemic pharmacological interventions for adults with non-specific LBP. METHODS: The Cochrane Database of Systematic Reviews was searched from inception to 3 June 2021, to identify reviews of randomised controlled trials (RCTs) that investigated systemic pharmacological interventions for adults with non-specific LBP. Two authors independently assessed eligibility, extracted data, and assessed the quality of the reviews and certainty of the evidence using the AMSTAR 2 and GRADE tools. The review focused on placebo comparisons and the main outcomes were pain intensity, function, and safety. MAIN RESULTS: Seven Cochrane Reviews that included 103 studies (22,238 participants) were included. There is high confidence in the findings of five reviews, moderate confidence in one, and low confidence in the findings of another. The reviews reported data on six medicines or medicine classes: paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, benzodiazepines, opioids, and antidepressants. Three reviews included participants with acute or sub-acute LBP and five reviews included participants with chronic LBP. Acute LBP Paracetamol There was high-certainty evidence for no evidence of difference between paracetamol and placebo for reducing pain intensity (MD 0.49 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -1.99 to 2.97), reducing disability (MD 0.05 on a 0 to 24 scale (higher scores indicate worse disability), 95% CI -0.50 to 0.60), and increasing the risk of adverse events (RR 1.07, 95% CI 0.86 to 1.33). NSAIDs There was moderate-certainty evidence for a small between-group difference favouring NSAIDs compared to placebo at reducing pain intensity (MD -7.29 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -10.98 to -3.61), high-certainty evidence for a small between-group difference for reducing disability (MD -2.02 on a 0-24 scale (higher scores indicate worse disability), 95% CI -2.89 to -1.15), and very low-certainty evidence for no evidence of an increased risk of adverse events (RR 0.86, 95% CI 0. 63 to 1.18). Muscle relaxants and benzodiazepines There was moderate-certainty evidence for a small between-group difference favouring muscle relaxants compared to placebo for a higher chance of pain relief (RR 0.58, 95% CI 0.45 to 0.76), and higher chance of improving physical function (RR 0.55, 95% CI 0.40 to 0.77), and increased risk of adverse events (RR 1.50, 95% CI 1. 14 to 1.98). Opioids None of the included Cochrane Reviews aimed to identify evidence for acute LBP. Antidepressants No evidence was identified by the included reviews for acute LBP. Chronic LBP Paracetamol No evidence was identified by the included reviews for chronic LBP. NSAIDs There was low-certainty evidence for a small between-group difference favouring NSAIDs compared to placebo for reducing pain intensity (MD -6.97 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -10.74 to -3.19), reducing disability (MD -0.85 on a 0-24 scale (higher scores indicate worse disability), 95% CI -1.30 to -0.40), and no evidence of an increased risk of adverse events (RR 1.04, 95% CI -0.92 to 1.17), all at intermediate-term follow-up (> 3 months and ≤ 12 months postintervention). Muscle relaxants and benzodiazepines There was low-certainty evidence for a small between-group difference favouring benzodiazepines compared to placebo for a higher chance of pain relief (RR 0.71, 95% CI 0.54 to 0.93), and low-certainty evidence for no evidence of difference between muscle relaxants and placebo in the risk of adverse events (RR 1.02, 95% CI 0.67 to 1.57). Opioids There was high-certainty evidence for a small between-group difference favouring tapentadol compared to placebo at reducing pain intensity (MD -8.00 on a 0 to 100 scale (higher scores indicate worse pain), 95% CI -1.22 to -0.38), moderate-certainty evidence for a small between-group difference favouring strong opioids for reducing pain intensity (SMD -0.43, 95% CI -0.52 to -0.33), low-certainty evidence for a medium between-group difference favouring tramadol for reducing pain intensity (SMD -0.55, 95% CI -0.66 to -0.44) and very low-certainty evidence for a small between-group difference favouring buprenorphine for reducing pain intensity (SMD -0.41, 95% CI -0.57 to -0.26). There was moderate-certainty evidence for a small between-group difference favouring strong opioids compared to placebo for reducing disability (SMD -0.26, 95% CI -0.37 to -0.15), moderate-certainty evidence for a small between-group difference favouring tramadol for reducing disability (SMD -0.18, 95% CI -0.29 to -0.07), and low-certainty evidence for a small between-group difference favouring buprenorphine for reducing disability (SMD -0.14, 95% CI -0.53 to -0.25). There was low-certainty evidence for a small between-group difference for an increased risk of adverse events for opioids (all types) compared to placebo; nausea (RD 0.10, 95% CI 0.07 to 0.14), headaches (RD 0.03, 95% CI 0.01 to 0.05), constipation (RD 0.07, 95% CI 0.04 to 0.11), and dizziness (RD 0.08, 95% CI 0.05 to 0.11). Antidepressants There was low-certainty evidence for no evidence of difference for antidepressants (all types) compared to placebo for reducing pain intensity (SMD -0.04, 95% CI -0.25 to 0.17) and reducing disability (SMD -0.06, 95% CI -0.40 to 0.29). AUTHORS' CONCLUSIONS: We found no high- or moderate-certainty evidence that any investigated pharmacological intervention provided a large or medium effect on pain intensity for acute or chronic LBP compared to placebo. For acute LBP, we found moderate-certainty evidence that NSAIDs and muscle relaxants may provide a small effect on pain, and high-certainty evidence for no evidence of difference between paracetamol and placebo. For safety, we found very low- and high-certainty evidence for no evidence of difference with NSAIDs and paracetamol compared to placebo for the risk of adverse events, and moderate-certainty evidence that muscle relaxants may increase the risk of adverse events. For chronic LBP, we found low-certainty evidence that NSAIDs and very low- to high-certainty evidence that opioids may provide a small effect on pain. For safety, we found low-certainty evidence for no evidence of difference between NSAIDs and placebo for the risk of adverse events, and low-certainty evidence that opioids may increase the risk of adverse events.

Cost-effectiveness of occupational therapy return-to-work interventions for people with mental health disorders: A systematic review.

BACKGROUND: Return-to-work (RTW) resources for persons with mental health disorders are limited and costs are typically shared by several stakeholders in society. Occupational therapists (OT) provide RTW interventions for this target group, however, increased knowledge of health, and employment effects, as well as costs are needed to better inform decision makers in their prioritisations. AIMS/OBJECTIVES: To identify and summarise evidence of cost-effectiveness of RTW interventions for persons with mental health disorders which OTs provide. MATERIALS AND METHODS: A systematic search was applied and resulted in 358 articles. After screening, nine articles met inclusion criteria and were reviewed. Quality assessment was conducted using the economic evaluation tool by Joanna Briggs Institute. RESULTS: Supported employment, Individual Placement and Support was cost-effective in several contexts while three studies showed larger effects and higher costs. An OT intervention added to treatment for major depression was indicated to be cost-beneficial and an advanced supported employment was cost-saving. The methodological quality varied considerably between studies. CONCLUSIONS AND SIGNIFICANCE: The results of the included studies are promising, however, to further strengthen the economic perspective in OT RTW interventions, the need for conducting more and methodologically robust economic evaluations is crucial in future studies.

Cost-effectiveness of specialised manual therapy versus orthopaedic care for musculoskeletal disorders: long-term follow-up and health economic model.

Background: Physiotherapy is usually the first line of treatment for musculoskeletal disorders. If pain persists, an appointment with an orthopaedic surgeon is indicated, but many disorders for which patients are placed on orthopaedic waiting lists cannot be treated in an orthopaedic clinic. Specialised manual therapy, although not mainstream, can be an effective alternative to orthopaedic care, although its cost-effectiveness beyond 12 months is unknown. Objectives: To perform an 8-year follow-up of the quality of life and costs of specialised manual therapy versus standard orthopaedic care for working-age patients with common nonsurgical musculoskeletal disorders referred to orthopaedic surgeons and to develop a health economic model. Design: Cost-effectiveness study using Markov modelling. Methods: The index group of a previously published pragmatic randomised controlled trial received a maximum of five treatment sessions of specialised manual therapy, while the control group received orthopaedic 'care as usual'. At 3, 6, 12 and 96 months, Health-Related Quality of Life and costs were measured with Short Form Health Survey 36, Short Form Health Survey 6D and Diagnostic Related Groups. An incremental cost-effectiveness ratio was calculated, a Markov model was developed and a sensitivity analysis was performed. Results: Overall, 95% (n = 75) of the participants completed the 8-year follow-up. Recovery rates during the first 3 months ('per protocol') in the index and control group were 69% and 58%, respectively. The index group had 0.159 more gains in quality-adjusted life years and cost 40,270 SEK (€4027) less per patient over 8 years. The sensitivity analysis results were consistent with the main results. Conclusion: Specialised manual therapy dominated standard care after 8 years. The results of this small but very first study are promising; therefore, further exploration within other health care professions, clinics and/or countries is required. Our study raises questions about the triaging of orthopaedic outpatients, cost-effectiveness and resource allocation. Registration: Not applicable per the information provided by ClinicalTrials.gov. Plain Language Summary: Specialised manual therapy is more cost-effective than 'care as usual' for working-age patients referred to an orthopaedist. This study provides an 8-year follow-up of the cost effects and quality of life of a previously published trial. Why was this study conducted? The standard care for musculoskeletal pain consists of exercises with a physiotherapist in primary care. If the pain persists, a referral to an orthopaedic clinic is often made. Many of these referrals are inappropriate because they concern pain from muscles and joints that do not benefit from surgery or the resources available in an orthopaedic clinic. There is a gap in competence and treatment between primary and specialised care that is costly, time- and resource-consuming and causes prolonged patient suffering. Although specialised manual therapy (MT) is effective, its use is not mainstream. Costs and effects after more than 12 months of treatment that may shorten waiting lists have never been evaluated. What did the researchers do? Quality of life and costs were compared in 75 patients with nonsurgical disorders referred to orthopaedic surgeons at 8 years after treatment with specialised MT or standard orthopaedic care. A health economics model for the probability of recovery was also developed and tested. What did the researchers find? Compared with the control group, the study participants treated with specialised MT had a better quality of life, required fewer health care interventions, underwent less surgery, incurred significantly lower costs and demonstrated an increased probability of recovery. What do these findings mean? It seems probable that using specialised MT for an old, well-known structural problem may yield better treatment effects at a significantly lower cost. Our study findings suggest that policy recommendations should focus on costs and effects rather than resource utilisation alone. The study is small and requires expansion using its economic health model.

Mapping Oswestry Disability Index Responses to EQ-5D-3L Utility Values: Are Cost-Utility Results Valid?

OBJECTIVES: To develop and validate approaches for mapping Oswestry Disability Index responses to 3-level version of EQ-5D utility values and to evaluate the impact of using mapped utility values on cost-utility results compared with published regression models. METHODS: Three response mapping approaches were developed in a random sample of 70% of 18 692 patients with low back pain: nonparametric approach (Non-p), nonparametric approach excluding logical inconsistencies (Non-peLI), and ordinal logistic regression (OLR). Performance was assessed in the remaining 30% using R-square (R2), root mean square error (RMSE), and mean absolute error (MAE). To evaluate whether MAEs and their 95% limits of agreement (LA) were clinically relevant, a minimally clinically important difference of 0.074 was used. Probabilities of cost-effectiveness estimated using observed and mapped utility values were compared in 2 economic evaluations. RESULTS: The Non-p performed the best (R2 = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R2 = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R2 = 0.22; RMSE = 0.26; MAE = 0.02; 95% LA = -0.49 to 0.53). MAEs were lower than the minimally clinically important difference for the Non-p and OLR but not for the Non-peLI. Differences in probabilities of cost-effectiveness ranged from 1% to 4% (Non-p), 0.1% to 9% (Non-peLI), and 0.1% to 20% (OLR). CONCLUSIONS: Results suggest that the developed response mapping approaches are not valid for estimating individual patients' 3-level version of EQ-5D utility values, and-depending on the approach-may considerably affect cost-utility results. The developed approaches did not perform better than previously published regression-based models and are therefore not recommended for use in economic evaluations.

Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial.

OBJECTIVES: To evaluate if adding motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) to usual case management (UC), reduced sickness absence over 6 months for workers on sick leave due to musculoskeletal disorders. METHODS: We conducted a three-arm parallel pragmatic randomised controlled trial including 514 employed workers (57% women, median age 49 (range 24-66)), on sick leave for at least 50% of their contracted work hours for ≥7 weeks. All participants received UC. In addition, those randomised to UC+MI were offered two MI sessions from social insurance caseworkers and those randomised to UC+SVAI were offered vocational advice from physiotherapists (participants with low/medium-risk for long-term sickness absence were offered one to two sessions, and those with high-risk were offered three to four sessions). RESULTS: Median sickness absence was 62 days, (95% CI 52 to 71) in the UC arm (n=171), 56 days (95% CI 43 to 70) in the UC+MI arm (n=169) and 49 days (95% CI 38 to 60) in the UC+SVAI arm (n=169). After adjusting for predefined potential confounding factors, the results showed seven fewer days in the UC+MI arm (95% CI -15 to 2) and the UC+SVAI arm (95% CI -16 to 1), compared with the UC arm. The adjusted differences were not statistically significant. CONCLUSIONS: The MI-NAV trial did not show effect on return to work of adding MI or SVAI to UC. The reduction in sickness absence over 6 months was smaller than anticipated, and uncertain due to wide CIs. TRIAL REGISTRATION NUMBER: NCT03871712.

Dealing with confounding in observational studies: A scoping review of methods evaluated in simulation studies with single-point exposure.

The aim of this article was to perform a scoping review of methods available for dealing with confounding when analyzing the effect of health care treatments with single-point exposure in observational data. We aim to provide an overview of methods and their performance assessed by simulation studies indexed in PubMed. We searched PubMed for simulation studies published until January 2021. Our search was restricted to studies evaluating binary treatments and binary and/or continuous outcomes. Information was extracted on the methods' assumptions, performance, and technical properties. Of 28,548 identified references, 127 studies were eligible for inclusion. Of them, 84 assessed 14 different methods (ie, groups of estimators that share assumptions and implementation) for dealing with measured confounding, and 43 assessed 10 different methods for dealing with unmeasured confounding. Results suggest that there are large differences in performance between methods and that the performance of a specific method is highly dependent on the estimator. Furthermore, the methods' assumptions regarding the specific data features also substantially influence the methods' performance. Finally, the methods result in different estimands (ie, target of inference), which can even vary within methods. In conclusion, when choosing a method to adjust for measured or unmeasured confounding it is important to choose the most appropriate estimand, while considering the population of interest, data structure, and whether the plausibility of the methods' required assumptions hold.

Reliability and responsiveness of the Danish version of The Chelsea Critical Care Physical Assessment tool (CPAx).

INTRODUCTION: Measurement instruments are important in clinical practice and research for assessing physical function in critically ill patients in the intensive care unit (ICU). OBJECTIVE: To investigate inter-rater reliability and responsiveness of the Danish version of the CPAx (CPAx-D). METHOD: Critically ill patients from three Danish ICUs were included. Patients were assessed with CPAx-D by two blinded testers during a regular physiotherapy session. Follow-up tests were performed in patients who stayed in the ICU for more than 24 hours, were not transferred to another hospital or received palliative care. Floor and ceiling effects were examined in all assessments.Results For the reliability analysis 66 patients were included.Results Showed no significant difference between raters. For the total score, intra class correlation coefficient (ICC) was 0.996 (95% CI: 0.993; 0.997), standard error of measurement was 0.72 point and minimal detectable change 2.0 points. Bland-Altman plot revealed no heteroscedacity. The responsiveness results of 24 patients showed that the effect size was 1.2 and the standardized response mean 1.1, which was in accordance with the hypothesis. No ceiling or floor effect was revealed. CONCLUSION: The CPAx-D showed excellent inter-rater reliability and responsiveness.

Measurement properties of performance-based instruments to assess mental function during activity and participation in persons who have survived a stroke: A systematic review protocol.

BACKGROUND: A frequent consequence of stroke is impaired mental function, which often affects the ability to perform activities and participate in life situation. In occupational therapy practice, performance-based instruments during activity and participation are often used. However, it is important to assess if the instruments used are valid, reliable and responsive. OBJECTIVE: The objective of this systematic review is to investigate measurement properties of performance-based instruments to assess mental function during activity and participation in persons who have survived stroke. MATERIAL AND METHODS: Systematic database searches of PubMed, EMBASE, CINAHL, PsycINFO, and OTseeker will be conducted. COSMIN Risk of Bias checklist will be used to evaluate methodological quality of the included articles. Measurement properties of the included studies will be rated against criteria for good measurement properties. The overall evidence of each measurement property per instrument is graded using a modified GRADE approach. RESULTS: Results will be presented in text and tables. CONCLUSIONS: Conclusion will be drawn up-on the overall evidence to give recommendations on the most suitable instrument. SIGNIFICANCE: It is expected that findings of the review will provide evidence to guide professionals in the selection of a performance-based instruments to measure mental function in practice and research. TRIAL REGISTRATION NUMBER: PROSPERO CRD42018086744.