Effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention for the prevention of low back pain recurrence in Australia (WalkBack): a randomised controlled trial.

BACKGROUND: Recurrence of low back pain is common and a substantial contributor to the disease and economic burden of low back pain. Exercise is recommended to prevent recurrence, but the effectiveness and cost-effectiveness of an accessible and low-cost intervention, such as walking, is yet to be established. We aimed to investigate the clinical effectiveness and cost-effectiveness of an individualised, progressive walking and education intervention to prevent the recurrence of low back pain. METHODS: WalkBack was a two-armed, randomised controlled trial, which recruited adults (aged 18 years or older) from across Australia who had recently recovered from an episode of non-specific low back pain that was not attributed to a specific diagnosis, and which lasted for at least 24 h. Participants were randomly assigned to an individualised, progressive walking and education intervention facilitated by six sessions with a physiotherapist across 6 months or to a no treatment control group (1:1). The randomisation schedule comprised randomly permuted blocks of 4, 6, and 8 and was stratified by history of more than two previous episodes of low back pain and referral method. Physiotherapists and participants were not masked to allocation. Participants were followed for a minimum of 12 months and a maximum of 36 months, depending on the date of enrolment. The primary outcome was days to the first recurrence of an activity-limiting episode of low back pain, collected in the intention-to-treat population via monthly self-report. Cost-effectiveness was evaluated from the societal perspective and expressed as incremental cost per quality-adjusted life-year (QALY) gained. The trial was prospectively registered (ACTRN12619001134112). FINDINGS: Between Sept 23, 2019, and June 10, 2022, 3206 potential participants were screened for eligibility, 2505 (78%) were excluded, and 701 were randomly assigned (351 to the intervention group and 350 to the no treatment control group). Most participants were female (565 [81%] of 701) and the mean age of participants was 54 years (SD 12). The intervention was effective in preventing an episode of activity-limiting low back pain (hazard ratio 0·72 [95% CI 0·60-0·85], p=0·0002). The median days to a recurrence was 208 days (95% CI 149-295) in the intervention group and 112 days (89-140) in the control group. The incremental cost per QALY gained was AU$7802, giving a 94% probability that the intervention was cost-effective at a willingness-to-pay threshold of $28 000. Although the total number of participants experiencing at least one adverse event over 12 months was similar between the intervention and control groups (183 [52%] of 351 and 190 [54%] of 350, respectively, p=0·60), there was a greater number of adverse events related to the lower extremities in the intervention group than in the control group (100 in the intervention group and 54 in the control group). INTERPRETATION: An individualised, progressive walking and education intervention significantly reduced low back pain recurrence. This accessible, scalable, and safe intervention could affect how low back pain is managed. FUNDING: National Health and Medical Research Council, Australia.

Opioid analgesia for acute low back pain and neck pain (the OPAL trial): a randomised placebo-controlled trial.

BACKGROUND: Opioid analgesics are commonly used for acute low back pain and neck pain, but supporting efficacy data are scarce. We aimed to investigate the efficacy and safety of a judicious short course of an opioid analgesic for acute low back pain and neck pain. METHODS: OPAL was a triple-blinded, placebo-controlled randomised trial that recruited adults (aged ≥18 years) presenting to one of 157 primary care or emergency department sites in Sydney, NSW, Australia, with 12 weeks or less of low back or neck pain (or both) of at least moderate pain severity. Participants were randomly assigned (1:1) using statistician-generated randomly permuted blocks to guideline-recommended care plus an opioid (oxycodone-naloxone, up to 20 mg oxycodone per day orally) or guideline-recommended care and an identical placebo, for up to 6 weeks. The primary outcome was pain severity at 6 weeks measured with the pain severity subscale of the Brief Pain Inventory (10-point scale), analysed in all eligible participants who provided at least one post-randomisation pain score, by use of a repeated measures linear mixed model. Safety was analysed in all randomly assigned eligible participants. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12615000775516). FINDINGS: Between Feb 29, 2016, and March 10, 2022, 347 participants were recruited (174 to the opioid group and 173 to the placebo group). 170 (49%) of 346 participants were female and 176 (51%) were male. 33 (19%) of 174 participants in the opioid group and 25 (15%) of 172 in the placebo group had discontinued from the trial by week 6, due to loss to follow-up and participant withdrawals. 151 participants in the opioid group and 159 in the placebo group were included in the primary analysis. Mean pain score at 6 weeks was 2·78 (SE 0·20) in the opioid group versus 2·25 (0·19) in the placebo group (adjusted mean difference 0·53, 95% CI -0·00 to 1·07, p=0·051). 61 (35%) of 174 participants in the opioid group reported at least one adverse event versus 51 (30%) of 172 in the placebo group (p=0·30), but more people in the opioid group reported opioid-related adverse events (eg, 13 [7·5%] of 174 participants in the opioid group reported constipation vs six [3·5%] of 173 in the placebo group). INTERPRETATION: Opioids should not be recommended for acute non-specific low back pain or neck pain given that we found no significant difference in pain severity compared with placebo. This finding calls for a change in the frequent use of opioids for these conditions. FUNDING: National Health and Medical Research Council, University of Sydney Faculty of Medicine and Health, and SafeWork SA.

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.

Effectiveness of Opioid Analgesic Medicines Prescribed in or at Discharge From Emergency Departments for Musculoskeletal Pain : A Systematic Review and Meta-analysis.

BACKGROUND: The comparative benefits and harms of opioids for musculoskeletal pain in the emergency department (ED) are uncertain. PURPOSE: To evaluate the comparative effectiveness and harms of opioids for musculoskeletal pain in the ED setting. DATA SOURCES: Electronic databases and registries from inception to 7 February 2022. STUDY SELECTION: Randomized controlled trials of any opioid analgesic compared with placebo or a nonopioid analgesic administered or prescribed to adults in or on discharge from the ED. DATA EXTRACTION: Pain and disability were rated on a scale of 0 to 100 and pooled using a random-effects model. Certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) framework. DATA SYNTHESIS: Forty-two articles were included (n = 6128). In the ED, opioids were statistically but not clinically more effective in reducing pain in the short term (about 2 hours) than placebo and paracetamol (acetaminophen) but were not clinically or statistically more effective than nonsteroidal anti-inflammatory drugs (NSAIDs) or local or systemic anesthetics. Opioids may carry higher risk for harms than placebo, paracetamol, or NSAIDs, although evidence is very uncertain. There was no evidence of difference in harms associated with local or systemic anesthetics. LIMITATIONS: Low or very low GRADE ratings for some outcomes, unexplained heterogeneity, and little information on long-term outcomes. CONCLUSION: The risk-benefit balance of opioids versus placebo, paracetamol, NSAIDs, and local or systemic anesthetics is uncertain. Opioids may have equivalent pain outcomes compared with NSAIDs, but evidence on comparisons of harms is very uncertain and heterogeneous. Although factors such as route of administration or dosage may explain some heterogeneity, more work is needed to identify which subgroups will have a more favorable benefit-risk balance for one analgesic over another. Longer-term pain management once dose thresholds are reached is also uncertain. PRIMARY FUNDING SOURCE: None. (PROSPERO: CRD42021275293).

A Low-Cost Modular Imaging System for Rapid, Multiplexed Immunofluorescence Detection in Clinical Tissues.

To image 4-plex immunofluorescence-stained tissue samples at a low cost with cellular level resolution and sensitivity and dynamic range required to detect lowly and highly abundant targets, here we describe a robust, inexpensive (<$9000), 3D printable portable imaging device (Tissue Imager). The Tissue Imager can immediately be deployed on benchtops for in situ protein detection in tissue samples. Applications for this device are broad, ranging from answering basic biological questions to clinical pathology, where immunofluorescence can detect a larger number of markers than the standard H&E or chromogenic immunohistochemistry (CIH) staining, while the low cost also allows usage in classrooms. After characterizing our platform's specificity and sensitivity, we demonstrate imaging of a 4-plex immunology panel in human cutaneous T-cell lymphoma (CTCL) formalin-fixed paraffin-embedded (FFPE) tissue samples. From those images, positive cells were detected using CellProfiler, a popular open-source software package, for tumor marker profiling. We achieved a performance on par with commercial epifluorescence microscopes that are >10 times more expensive than our Tissue Imager. This device enables rapid immunofluorescence detection in tissue sections at a low cost for scientists and clinicians and can provide students with a hands-on experience to understand engineering and instrumentation. We note that for using the Tissue Imager as a medical device in clinical settings, a comprehensive review and approval processes would be required.

The Prevalence of Opioid Analgesic Use in People with Chronic Noncancer Pain: Systematic Review and Meta-Analysis of Observational Studies.

OBJECTIVE: To review studies examining the proportion of people with chronic noncancer pain who report consuming opioids and characteristics associated with their use. DESIGN: Systematic review. METHODS: We searched databases from inception to February 8, 2020, and conducted citation tracking. We included observational studies reporting the proportion of adults with chronic noncancer pain who used opioid analgesics. Opioids were categorized as weak (e.g., codeine) or strong (e.g., oxycodone). Study risk of bias was assessed, and Grading of Recommendations Assessment, Development and Evaluations provided a summary of the overall quality. Results were pooled using a random-effects model. Meta-regression determined factors associated with opioid use. RESULTS: Sixty studies (N=3,961,739) reported data on opioid use in people with chronic noncancer pain from 1990 to 2017. Of these 46, 77% had moderate risk of bias. Opioid use was reported by 26.8% (95% confidence interval [CI], 23.1-30.8; moderate-quality evidence) of people with chronic noncancer pain. The use of weak opioids (17.3%; 95% CI 11.9-24.4; moderate-quality evidence) was more common than the use of strong opioids (9.8%; 95% CI, 6.8-14.0; low-quality evidence). Meta-regression determined that opioid use was associated with geographic region (P=0.02; lower in Europe than North America), but not sampling year (P=0.77), setting (P=0.06), diagnosis (P=0.34), or disclosure of funding (P=0.77). CONCLUSIONS: Our review summarized data from over 3.9 million people with chronic noncancer pain reporting their opioid use. Between 1990 and 2017, one-quarter of people with chronic noncancer pain reported taking opioids, and this proportion did not change over time.

Healthcare expenditure and its predictors in a cohort of Australians living with sciatica.

PURPOSE: To estimate the healthcare resource utilisation of an Australian cohort of people with sciatica and explore individual-level factors associated with expenditure. METHODS: Healthcare utilisation (services and medication) data from a randomised, double-blind, placebo-controlled trial of pregabalin in patients with sciatica (n = 185) were analysed to estimate healthcare expenditure of participants over 12 months. Associations between key baseline socio-economic, pain and quality of life characteristics and healthcare expenditure were examined using generalised linear imputation models. RESULTS: On average, participants accessed AUD$1,134 of healthcare over the year, predominantly made up of $114 of medication and $914 of health services, which included $418 of physiotherapy services. Participants randomised to receive pregabalin incurred higher expenditure ($1,263 compared to $1,001 for placebo), which was largely driven by pregabalin ($158) and greater health services ($107). Healthcare expenditure was significantly higher for participants prescribed pregabalin, earning greater than $1,700 per week ($88,400 per year) and reporting poorer quality of life (physical and mental). CONCLUSION: Our results suggest inefficiency in the use of healthcare resources due to increased healthcare resource utilisation in people with sciatica treated with pregabalin, compared to placebo. Costs of treating sciatica varied based on individual quality of life and socio-economic characteristics.

Cost-effectiveness of exercise therapy in the treatment of non-specific neck pain and low back pain: a systematic review with meta-analysis.

OBJECTIVE: To investigate the cost-effectiveness of exercise therapy in the treatment of patients with non-specific neck pain and low back pain. DESIGN: Systematic review of economic evaluations. DATA SOURCES: The search was performed in 5 clinical and 3 economic electronic databases. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: We included economic evaluations performed alongside randomised controlled trials. Differences in costs and effects were pooled in a meta-analysis, if possible, and incremental cost-utility ratios (ICUR) were descriptively analysed. RESULTS: Twenty-two studies were included. On average, exercise therapy was associated with lower costs and larger effects for quality-adjusted life-year (QALY) in comparison with usual care for subacute and chronic low back pain from a healthcare perspective (based on ICUR). Exercise therapy had similar costs and effect for QALY in comparison with other interventions for neck pain from a societal perspective, and subacute and chronic low back pain from a healthcare perspective. There was limited or inconsistent evidence on the cost-effectiveness of exercise therapy compared with usual care for neck pain and acute low back pain, other interventions for acute low back pain and different types of exercise therapy for neck pain and low back pain. CONCLUSIONS: Exercise therapy seems to be cost-effective compared with usual care for subacute and chronic low back pain. Exercise therapy was not (more) cost-effective compared with other interventions for neck pain and low back pain. The cost-utility estimates are rather uncertain, indicating that more economic evaluations are needed. REGISTRATION: PROSPERO, CRD42017059025.

Worsening trends in analgesics recommended for spinal pain in primary care.

PURPOSE: Limited evidence exists on secular trends of analgesics for spinal pain. We investigated general practitioner's (GP) recommendations of analgesic medicines for spinal pain and investigated characteristics associated with their recommendation. METHODS: We accessed data on spinal pain consultations from the Bettering the Evaluation and Care of Health (BEACH) database, a nationally representative database on GP activity in Australia. Data extracted included consultation details and management provided. Medicines recommended were grouped as simple analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), opioid analgesics or neuropathic pain medicines. Multivariate logistic regression determined if patient characteristics and GP characteristics were associated with medication recommendations. RESULTS: We analysed BEACH data for 9100 GPs who managed 39,303 patients with spinal pain between 2004 and 2014. Over the decade, analgesic recommendations increased. After accounting for patient and GP characteristics, there was a significant increase in the rate single-ingredient opioid analgesics [annual relative increase of 6% (RR 1.06 (95% CI 1.05-1.07), P < 0.001)] and neuropathic pain medicines [annual relative increase of 19% (RR 1.19 (95% CI 1.16-1.22), P < 0.001)] were recommended; and a significant decrease in the rate NSAIDs were recommended [annual relative decrease of 4% (RR 0.96 (95% CI 0.95-0.97), P < 0.001)]. Logistic regression identified several patient and GP characteristics associated with medicine recommendations, e.g. stronger opioids were less likely recommended for Indigenous patients [odds ratio 0.15 (95% CI 0.04-0.56)]. CONCLUSIONS: GP's analgesic recommendations for spinal pain have become increasingly divergent from guideline recommendations over time.

Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview.

OBJECTIVE: The aim of this study was to provide an overview of the recommendations regarding the diagnosis and treatment contained in current clinical practice guidelines for patients with non-specific low back pain in primary care. We also aimed to examine how recommendations have changed since our last overview in 2010. METHOD: The searches for clinical practice guidelines were performed for the period from 2008 to 2017 in electronic databases. Guidelines including information regarding either the diagnosis or treatment of non-specific low back pain, and targeted at a multidisciplinary audience in the primary care setting, were considered eligible. We extracted data regarding recommendations for diagnosis and treatment, and methods for development of guidelines. RESULTS: We identified 15 clinical practice guidelines for the management of low back pain in primary care. For diagnosis of patients with non-specific low back pain, the clinical practice guidelines recommend history taking and physical examination to identify red flags, neurological testing to identify radicular syndrome, use of imaging if serious pathology is suspected (but discourage routine use), and assessment of psychosocial factors. For treatment of patients with acute low back pain, the guidelines recommend reassurance on the favourable prognosis and advice on returning to normal activities, avoiding bed rest, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and weak opioids for short periods. For treatment of patients with chronic low back pain, the guidelines recommend the use of NSAIDs and antidepressants, exercise therapy, and psychosocial interventions. In addition, referral to a specialist is recommended in case of suspicion of specific pathologies or radiculopathy or if there is no improvement after 4 weeks. While there were a few discrepancies across the current clinical practice guidelines, a substantial proportion of recommendations was consistently endorsed. In the current review, we identified some differences compared to the previous overview regarding the recommendations for assessment of psychosocial factors, the use of some medications (e.g., paracetamol) as well as an increasing amount of information regarding the types of exercise, mode of delivery, acupuncture, herbal medicines, and invasive treatments. These slides can be retrieved under Electronic Supplementary Material.

The economic burden of guideline-recommended first line care for acute low back pain.

PURPOSE: To report health care costs and the factors associated with such costs in people with acute low back pain receiving guideline-recommended first line care. METHODS: This is a secondary analysis of a trial which found no difference in clinical outcomes. Participants with acute low back pain received reassurance and advice, and either paracetamol (taken regularly or as needed) or placebo for up to 4 weeks and followed up for 12 weeks. Data on health service utilisation were collected by self-report. A health sector perspective was adopted to report all direct costs incurred (in 2015 AUD, 1 AUD = 0.53 Euro). Costs were reported for the entire study cohort and for each group. Various baseline clinical, demographic, work-related and socioeconomic factors were investigated for their association with increased costs using generalised linear models. RESULTS: The mean cost per participant was AUD167.74 (SD = 427.24) for the entire cohort (n = 1365). Most of these costs were incurred in primary care through visits to a general practitioner or physiotherapist. Compared to the placebo group, there was an increase in cost when paracetamol was taken. Multivariate analysis showed that disability, symptom duration and compensation were associated with costs. Receiving compensation was associated with a twofold increase compared to not receiving compensation. CONCLUSIONS: Taking paracetamol as part of first line care for acute low back pain increased the economic burden. Higher disability, longer symptom duration and receiving compensation were independently associated with increased health care costs.

Vaginal wellness: whose turf is it?

Dermatologists were the pioneers in the development of laser technology and have the most experience using these lasers to treat the external genitalia for many cutaneous disorders. Dermatologists who have experience and expertise using lasers and devices, are already using them to treat the external genitalia, and are comfortable performing female gynecologic exams may want to explore the wide range of options that are available to treat the functional and aesthetic needs of the female population. Dermatologists should work with obstetricians and gynecologists to ensure that patients are proper candidates for the procedures.

Comparison of effect sizes between enriched and nonenriched trials of analgesics for chronic musculoskeletal pain: a systematic review.

AIMS: To investigate the use of an enriched study design on the estimates of treatment effect in analgesic trials for chronic musculoskeletal pain. METHODS: Database searches were conducted from 2004 to 2014. We included randomized placebo-controlled trials evaluating pain medications for chronic musculoskeletal pain. Methodological quality was assessed using the PEDro scale. The estimates of treatment effect on pain and adverse events were compared between enriched and nonenriched designs. Metaregression was used to assess the association between the effect size estimate and the study design controlling for analgesic dose and methodological quality. RESULTS: We included 108 trials, of which 99 were included in the meta-analysis (n = 44 171). There were no overall differences in effect sizes between enriched and nonenriched designs for pain intensity. There was a significant difference for a reduction in any adverse events favouring enriched designs for opioids, but not for other analgesics or the outcome serious adverse events. There was an association between effect size and methodological quality, with failure to blind the outcome assessor and failure to use intention-to-treat analysis being associated with larger effect sizes. CONCLUSIONS: There is no evidence that the use of an enriched study design changes the treatment effect size estimate for pain. There is some evidence that clinical trials that employ enriched designs report a reduced risk of adverse events in trials for chronic musculoskeletal pain, but it is unclear whether enriched designs influence estimates of serious adverse events. Features of trial design and study quality were associated with treatment effect estimates.

Back Schools for chronic non-specific low back pain.

BACKGROUND: Many people with low back pain (LBP) become frequent users of healthcare services in their attempt to find treatments that minimise the severity of their symptoms. Back School consists of a therapeutic programme given to groups of people that includes both education and exercise. However, the content of Back School has changed over time and appears to vary widely today. This review is an update of a Cochrane review of randomised controlled trials (RCTs) evaluating the effectiveness of Back School. We split the Cochrane review into two reviews, one focusing on acute and subacute LBP, and one on chronic LBP. OBJECTIVES: The objective of this systematic review was to determine the effect of Back School on pain and disability for adults with chronic non-specific LBP; we included adverse events as a secondary outcome. In trials that solely recruited workers, we also examined the effect on work status. SEARCH METHODS: We searched for trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, two other databases and two trials registers to 15 November 2016. We also searched the reference lists of eligible papers and consulted experts in the field of LBP management to identify any potentially relevant studies we may have missed. We placed no limitations on language or date of publication. SELECTION CRITERIA: We included only RCTs and quasi-RCTs evaluating pain, disability, and/or work status as outcomes. The primary outcomes for this update were pain and disability, and the secondary outcomes were work status and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently performed the 'Risk of bias' assessment of the included studies using the 'Risk of bias' assessment tool recommended by The Cochrane Collaboration. We summarised the results for the short-, intermediate-, and long-term follow-ups. We evaluated the overall quality of evidence using the GRADE approach. MAIN RESULTS: For the outcome pain, at short-term follow-up, we found very low-quality evidence that Back School is more effective than no treatment (mean difference (MD) -6.10, 95% confidence interval (CI) -10.18 to -2.01). However, we found very low-quality evidence that there is no significant difference between Back School and no treatment at intermediate-term (MD -4.34, 95% CI -14.37 to 5.68) or long-term follow-up (MD -12.16, 95% CI -29.14 to 4.83). There was very low-quality evidence that Back School reduces pain at short-term follow-up compared to medical care (MD -10.16, 95% CI -19.11 to -1.22). Very low-quality evidence showed there to be no significant difference between Back School and medical care at intermediate-term (MD -9.65, 95% CI -22.46 to 3.15) or long-term follow-up (MD -5.71, 95% CI -20.27 to 8.84). We found very low-quality evidence that Back School is no more effective than passive physiotherapy at short-term (MD 1.96, 95% CI -9.51 to 13.43), intermediate-term (MD -16.89, 95% CI -66.56 to 32.79), or long-term follow-up (MD -12.86, 95% CI -61.22 to 35.50). There was very low-quality evidence that Back School is no better than exercise at short- term follow-up (MD -2.06, 95% CI -14.58 to 10.45). There was low-quality evidence that Back School is no better than exercise at intermediate-term (MD -4.46, 95% CI -19.44 to 10.52) and long-term follow-up (MD 4.58, 95% CI -0.20 to 9.36).For the outcome disability, we found very low-quality evidence that Back School is no more effective than no treatment at intermediate-term (MD -5.92, 95% CI -12.08 to 0.23) and long-term follow-up (MD -7.36, 95% CI -22.05 to 7.34); medical care at short-term (MD -1.19, 95% CI -7.02 to 4.64) and long-term follow-up (MD -0.40, 95% CI -7.33 to 6.53); passive physiotherapy at short-term (MD 2.57, 95% CI -15.88 to 21.01) and intermediate-term follow-up (MD 6.88, 95% CI -4.86 to 18.63); and exercise at short-term (MD -1.65, 95% CI -8.66 to 5.37), intermediate-term (MD 1.57, 95% CI -3.86 to 7.00), and long-term follow-up (MD 4.54, 95% CI -4.44 to 13.52). We found very low-quality evidence of a small difference between Back School and no treatment at short-term follow-up (MD -3.38, 95% CI -6.70 to -0.05) and medical care at intermediate-term follow-up (MD -6.34, 95% CI -10.89 to -1.79). Still, at long-term follow-up there was very low-quality evidence that passive physiotherapy is better than Back School (MD 9.60, 95% CI 3.65 to 15.54).Few studies measured adverse effects. The results were reported as means without standard deviations or group size was not reported. Due to this lack of information, we were unable to statistically pool the adverse events data. Work status was not reported. AUTHORS' CONCLUSIONS: Due to the low- to very low-quality of the evidence for all treatment comparisons, outcomes, and follow-up periods investigated, it is uncertain if Back School is effective for chronic low back pain. Although the quality of the evidence was mostly very low, the results showed no difference or a trivial effect in favour of Back School. There are myriad potential variants on the Back School approach regarding the employment of different exercises and educational methods. While current evidence does not warrant their use, future variants on Back School may have different effects and will need to be studied in future RCTs and reviews.

Diagnostic accuracy of the Ottawa Ankle and Midfoot Rules: a systematic review with meta-analysis.

OBJECTIVE: To review the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules and explore if clinical features and/or methodological quality of the study influence diagnostic accuracy estimates. DESIGN: Systematic review with meta-analysis. DATA SOURCES: MEDLINE, EMBASE, CINAHL, SPORTDiscus and Cochrane Library. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Primary diagnostic studies reporting the accuracy of the Rules in people with ankle and/or midfoot injury were retrieved. Diagnostic accuracy estimates, overall and for subgroups (patient's age, profession of the assessor and setting of application), were made. Sensitivity analyses included studies with a low risk of bias and studies where all patients received radiographs. RESULTS: 66 studies were included. Ankle and Midfoot Rules presented similar accuracies, which were homogeneous and high for sensitivity and negative likelihood ratios and poor and heterogeneous for specificity and positive likelihood ratios (mean, 95% CI pooled sensitivity of Ankle Rules: 99.4%, 97.9% to 99.8%; specificity: 35.3%, 28.8% to 42.3%). Sensitivity of the Ankle Rules was higher in adults than in children, but the profession of the assessor did not appear to influence accuracy. Specificity was higher for Midfoot than for Ankle Rules. There were not enough studies to allow comparison according to setting of application. Studies with a low risk of bias and where all patients received radiographs provided lower accuracy estimates. Specificity heterogeneity was not explained by assessor training, use of imaging in all patients and low risk of bias. CONCLUSIONS: Study features and the methodological quality influence estimates of the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules.

Predictors of asthma exacerbation among patients with poorly controlled asthma despite inhaled corticosteroid treatment.

BACKGROUND: Asthma exacerbations are associated with decreased quality of life and increased health care usage. Identification of characteristics that predict increased risk of future exacerbations in patients with suboptimal control of asthma could guide treatment decisions. OBJECTIVE: To examine patient characteristics associated with risk of asthma exacerbations in patients with uncontrolled persistent asthma. METHODS: A retrospective analysis of adults and children with inadequately controlled asthma despite asthma controller therapy and enrolled in 2 randomized trials was conducted. Baseline characteristics of subjects who experienced an asthma exacerbation during the treatment period were compared with those of subjects who did not experience an exacerbation. RESULTS: Of 718 subjects (402 adults and 295 children), 108 adults (27%) and 110 children (37%) experienced an asthma exacerbation during the study period. Unscheduled health care visits for asthma or use of oral corticosteroids in the previous year were significantly associated with asthma exacerbation during the study period (P < .01). Adult subjects who experienced an exacerbation had significantly lower forced expiratory volume in 1 second compared with those who did not (2.3 vs 2.5 L, respectively, P = .02). Children who experienced an exacerbation had lower baseline pre- and post-bronchodilator ratios of forced expiratory volume in 1 second to forced vital capacity (77% vs 81%, P < .01; 82% vs 86%, P < .001, respectively). Symptom scores on validated questionnaires were significantly worse in adults but not in children who developed an exacerbation. CONCLUSION: Spirometric measurements can help identify adults and children at increased risk for asthma exacerbation. Symptom scores could be helpful in identifying adults who are at high risk for exacerbations but could be less helpful in children.

Back schools for acute and subacute non-specific low-back pain.

BACKGROUND: Since the introduction of the Swedish back school in 1969, back schools have frequently been used for treating people with low-back pain (LBP). However, the content of back schools has changed and appears to vary widely today. In this review we defined back school as a therapeutic programme given to groups of people, which includes both education and exercise. This is an update of a Cochrane review first published in 1999, and updated in 2004. For this review update, we split the review into two distinct reviews which separated acute from chronic LBP. OBJECTIVES: To assess the effectiveness of back schools on pain and disability for people with acute or subacute non-specific LBP. We also examined the effect on work status and adverse events. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, PubMed and two clinical trials registers up to 4 August 2015. We also checked the reference lists of articles and contacted experts in the field of research on LBP. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-RCTs that reported on back school for acute or subacute non-specific LBP. The primary outcomes were pain and disability. The secondary outcomes were work status and adverse events. Back school had to be compared with another treatment, a placebo (or sham or attention control) or no treatment. DATA COLLECTION AND ANALYSIS: We used the 2009 updated method guidelines for this Cochrane review. Two review authors independently screened the references, assessed the quality of the trials and extracted the data. We set the threshold for low risk of bias, a priori, as six or more of 13 internal validity criteria and no serious flaws (e.g. large drop-out rate). We classified the quality of the evidence into one of four levels (high, moderate, low or very low) using the adapted Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. We contacted study authors for additional information. We collected adverse effects information from the trials. MAIN RESULTS: The search update identified 273 new references, of which none fulfilled our inclusion criteria. We included four studies (643 participants) in this updated review, which were all included in the previous (2004) update. The quality of the evidence was very low for all outcomes. As data were too clinically heterogeneous to be pooled, we described individual trial results. The results indicate that there is very low quality evidence that back schools are no more effective than a placebo (or sham or attention control) or another treatment (physical therapies, myofascial therapy, joint manipulations, advice) on pain, disability, work status and adverse events at short-term, intermediate-term and long-term follow-up. There is very low quality evidence that shows a statistically significant difference between back schools and a placebo (or sham or attention control) for return to work at short-term follow-up in favour of back school. Very low quality evidence suggests that back school added to a back care programme is more effective than a back care programme alone for disability at short-term follow-up. Very low quality evidence also indicates that there is no difference in terms of adverse events between back school and myofascial therapy, joint manipulation and combined myofascial therapy and joint manipulation. AUTHORS' CONCLUSIONS: It is uncertain if back schools are effective for acute and subacute non-specific LBP as there is only very low quality evidence available. While large well-conducted studies will likely provide more conclusive findings, back schools are not widely used interventions for acute and subacute LBP and further research into this area may not be a priority.

Diagnostic accuracy of FEV1/forced vital capacity ratio z scores in asthmatic patients.

BACKGROUND: The FEV1/forced vital capacity (FVC) ratio is used as a criterion for airflow obstruction; however, the test characteristics of spirometry in the diagnosis of asthma are not well established. The accuracy of a test depends on the pretest probability of disease. OBJECTIVE: We wanted to estimate the FEV1/FVC ratio z score threshold with optimal accuracy for the diagnosis of asthma for different pretest probabilities. METHODS: Asthmatic patients enrolled in 4 trials from the Asthma Clinical Research Centers were included in this analysis. Measured and predicted FEV1/FVC ratios were obtained, with calculation of z scores for each participant. Across a range of asthma prevalences and z score thresholds, the overall diagnostic accuracy was calculated. RESULTS: One thousand six hundred eight participants were included (mean age, 39 years; 71% female; 61% white). The mean FEV1 percent predicted value was 83% (SD, 15%). In a symptomatic population with 50% pretest probability of asthma, optimal accuracy (68%) is achieved with a z score threshold of -1.0 (16th percentile), corresponding to a 6 percentage point reduction from the predicted ratio. However, in a screening population with a 5% pretest probability of asthma, the optimum z score is -2.0 (second percentile), corresponding to a 12 percentage point reduction from the predicted ratio. These findings were not altered by markers of disease control. CONCLUSION: Reduction of the FEV1/FVC ratio can support the diagnosis of asthma; however, the ratio is neither sensitive nor specific enough for diagnostic accuracy. When interpreting spirometric results, consideration of the pretest probability is an important consideration in the diagnosis of asthma based on airflow limitation.