Radiofrequency denervation is a commonly used treatment for chronic low back pain, but high-quality evidence for its effectiveness is lacking.
To evaluate the effectiveness of radiofrequency ...denervation added to a standardized exercise program for patients with chronic low back pain.
Three pragmatic multicenter, nonblinded randomized clinical trials on the effectiveness of minimal interventional treatments for participants with chronic low back pain (Mint study) were conducted in 16 multidisciplinary pain clinics in the Netherlands. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain, a positive diagnostic block at the facet joints (facet joint trial, 251 participants), sacroiliac joints (sacroiliac joint trial, 228 participants), or a combination of facet joints, sacroiliac joints, or intervertebral disks (combination trial, 202 participants) and were unresponsive to conservative care.
All participants received a 3-month standardized exercise program and psychological support if needed. Participants in the intervention group received radiofrequency denervation as well. This is usually a 1-time procedure, but the maximum number of treatments in the trial was 3.
The primary outcome was pain intensity (numeric rating scale, 0-10; whereby 0 indicated no pain and 10 indicated worst pain imaginable) measured 3 months after the intervention. The prespecified minimal clinically important difference was defined as 2 points or more. Final follow-up was at 12 months, ending October 2015.
Among 681 participants who were randomized (mean age, 52.2 years; 421 women 61.8%, mean baseline pain intensity, 7.1), 599 (88%) completed the 3-month follow-up, and 521 (77%) completed the 12-month follow-up. The mean difference in pain intensity between the radiofrequency denervation and control groups at 3 months was -0.18 (95% CI, -0.76 to 0.40) in the facet joint trial; -0.71 (95% CI, -1.35 to -0.06) in the sacroiliac joint trial; and -0.99 (95% CI, -1.73 to -0.25) in the combination trial.
In 3 randomized clinical trials of participants with chronic low back pain originating in the facet joints, sacroiliac joints, or a combination of facet joints, sacroiliac joints, or intervertebral disks, radiofrequency denervation combined with a standardized exercise program resulted in either no improvement or no clinically important improvement in chronic low back pain compared with a standardized exercise program alone. The findings do not support the use of radiofrequency denervation to treat chronic low back pain from these sources.
trialregister.nl Identifier: NTR3531.
Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical ...guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients' self-management and, consequently, may reduce LBP-related costs.
We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP.
An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation.
Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference MD -1.1, 95% CI -3.9 to 1.7) and QALYs (MD 0.026, 95% CI -0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD -4.3, 95% CI -7.3 to -1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 US $1027, 95% CI -€1090 to €3264 US -$1151 to $3448; health care: €73 US $77, 95% CI -€59 to €225 US -$62 to $238). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy.
The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP.
ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203.
RR2-10.1186/s12891-020-3174-z.
...a qualitative assessment among decision-makers in the Ontario healthcare sector showed that financial information - mostly in the form of a business case - can be a key deciding factor of whether ...to go forward with implementation of an intervention or occupational health service (3). ...economic evaluations in occupational health are highly heterogeneous in terms of their productivity-related cost estimation methods and large differences exist across studies in terms of the validity and transparent reporting of applied methods (9). ...it is questionable whether the recommended friction cost approach is appropriate from the company perspective as well. Johanna M van Dongen, PhD,1' 2 Allard J van der Beek, PhD 3 1 Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Movement Sciences Research Institute, The Netherlands. 2 Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, The Netherlands. 3 Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, The Netherlands.
To investigate the cost-effectiveness of exercise therapy in the treatment of patients with non-specific neck pain and low back pain.
Systematic review of economic evaluations.
The search was ...performed in 5 clinical and 3 economic electronic databases.
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.
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.
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.
PROSPERO, CRD42017059025.
Blended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may ...reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective.
This economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty.
Intervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (< 0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective.
E-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist.
NTR4224 (25 October 2013).
The statistical quality of trial‐based economic evaluations is often suboptimal, while a comprehensive overview of available statistical methods is lacking. Therefore, this review summarized and ...critically appraised available statistical methods for trial‐based economic evaluations. A literature search was performed to identify studies on statistical methods for dealing with baseline imbalances, skewed costs and/or effects, correlated costs and effects, clustered data, longitudinal data, missing data and censoring in trial‐based economic evaluations. Data was extracted on the statistical methods described, their advantages, disadvantages, relative performance and recommendations of the study. Sixty‐eight studies were included. Of them, 27 (40%) assessed methods for baseline imbalances, 39 (57%) assessed methods for skewed costs and/or effects, 27 (40%) assessed methods for correlated costs and effects, 18 (26%) assessed methods for clustered data, 7 (10%) assessed methods for longitudinal data, 26 (38%) assessed methods for missing data and 10 (15%) assessed methods for censoring. All identified methods were narratively described. This review provides a comprehensive overview of available statistical methods for dealing with the most common statistical complexities in trial‐based economic evaluations. Herewith, it can provide valuable input for researchers when deciding which statistical methods to use in a trial‐based economic evaluation.
To assess the impact of EQ-5D country-specific value sets on cost-utility outcomes.
Data from 2 randomized controlled trials on low back pain (LBP) and depression were used. 3L value sets were ...identified from the EuroQol Web site. A nonparametric crosswalk was employed for each tariff to obtain the likely 5L values. Differences in quality-adjusted life years (QALYs) between countries were tested using paired t tests, with United Kingdom as reference. Cost-utility outcomes were estimated for both studies and both EQ-5D versions, including differences in QALYs and cost-effectiveness acceptability curves.
For the 3L, QALYs ranged between 0.650 (Taiwan) and 0.892 (United States) in the LBP study and between 0.619 (Taiwan) and 0.879 (United States) in the depression study. In both studies, most country-specific QALY estimates differed statistically significantly from that of the United Kingdom. Incremental cost-effectiveness ratios ranged between 2044/QALY (Taiwan) and 5897/QALY (Zimbabwe) in the LBP study and between 38,287/QALY (Singapore) and 96,550/QALY (Japan) in the depression study. At the NICE threshold of 23,300/QALY (≈£20,000/QALY), the intervention's probability of being cost-effective versus control ranged between 0.751 (Zimbabwe) and 0.952 (Taiwan) and between 0.230 (Canada) and 0.396 (Singapore) in the LBP study and depression study, respectively. Similar results were found for the 5L, with extensive differences in ICERs and moderate differences in the probability of cost-effectiveness.
This study indicates that the use of different EQ-5D country-specific value sets impacts on cost-utility outcomes. Therefore, to account for the fact that health state preferences are affected by sociocultural differences, relevant country-specific value sets should be used.
Background
There is limited evidence on the cost effectiveness of Internet‐based treatments for depression. The aim was to evaluate the cost effectiveness of guided Internet‐based interventions for ...depression compared to controls.
Methods
Individual–participant data from five randomized controlled trials (RCT), including 1,426 participants, were combined. Cost‐effectiveness analyses were conducted at 8 weeks, 6 months, and 12 months follow‐up.
Results
The guided Internet‐based interventions were more costly than the controls, but not statistically significant (12 months mean difference = €406, 95% CI: − 611 to 1,444). The mean differences in clinical effects were not statistically significant (12 months mean difference = 1.75, 95% CI: − .09 to 3.60 in Center for Epidemiologic Studies Depression Scale CES‐D score, .06, 95% CI: − .02 to .13 in response rate, and .00, 95% CI: − .03 to .03 in quality‐adjusted life‐years QALYs). Cost‐effectiveness acceptability curves indicated that high investments are needed to reach an acceptable probability that the intervention is cost effective compared to control for CES‐D and response to treatment (e.g., at 12‐month follow‐up the probability of being cost effective was .95 at a ceiling ratio of 2,000 €/point of improvement in CES‐D score). For QALYs, the intervention's probability of being cost effective compared to control was low at the commonly accepted willingness‐to‐pay threshold (e.g., at 12‐month follow‐up the probability was .29 and. 31 at a ceiling ratio of 24,000 and 35,000 €/QALY, respectively).
Conclusions
Based on the present findings, guided Internet‐based interventions for depression are not considered cost effective compared to controls. However, only a minority of RCTs investigating the clinical effectiveness of guided Internet‐based interventions also assessed cost effectiveness and were included in this individual–participant data meta‐analysis.
Abstract
Background: Consumption of coffee, one of the most popular beverages around the world, has been associated with a lower risk of cardiovascular and all-cause mortality in population-based ...studies. However, little is known about these associations in patient populations.
Objective: This prospective study aimed to examine the consumption of caffeinated and decaffeinated coffee in relation to cardiovascular disease (CVD) mortality, ischemic heart disease (IHD) mortality, and all-cause mortality in patients with a prior myocardial infarction (MI).
Design: We included 4365 Dutch patients from the Alpha Omega Cohort who were aged 60–80 y (21% female) and had experienced an MI <10 y before study enrollment. At baseline (2002–2006), dietary data including coffee consumption over the past month was collected with a 203-item validated food-frequency questionnaire. Causes of death were monitored until 1 January 2013. HRs for mortality in categories of coffee consumption were obtained from multivariable Cox proportional hazard models, adjusting for lifestyle and dietary factors.
Results: Most patients (96%) drank coffee, and the median total coffee intake was 375 mL/d (∼3 cups/d). During a median follow-up of 7.1 y, a total of 945 deaths occurred, including 396 CVD-related and 266 IHD-related deaths. Coffee consumption was inversely associated with CVD mortality, with HRs of 0.69 (95% CI: 0.54, 0.89) for >2–4 cups/d and 0.72 (0.55, 0.95) for >4 cups/d, compared with 0–2 cups/d. Corresponding HRs were 0.77 (95% CI: 0.57, 1.05) and 0.68 (95% CI: 0.48, 0.95) for IHD mortality and 0.84 (95% CI: 0.71, 1.00) and 0.82 (95% CI: 0.68, 0.98) for all-cause mortality, respectively. Similar associations were found for decaffeinated coffee and for coffee with additives.
Conclusion: Drinking coffee, either caffeinated or decaffeinated, may lower the risk of CVD and IHD mortality in patients with a prior MI. This study was registered at clinicaltrials.gov as NCT03192410.
Background and purpose: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and ...surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences.Methods and analyses: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10–18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.
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