Background
Societal costs of low back pain (LBP) are high, yet few studies have been performed to identify the predictive factors of high societal costs among chronic LBP patients. This study aimed ...to determine which factors predict high societal costs in patients with chronic LBP.
Methods
Data of 6,316 chronic LBP patients were used. In the main analysis, high societal costs were defined as patients in the top 10% of cost outcomes. Sensitivity analyses were conducted using patients in the top 5% and top 20% of societal costs. Potential predictive factors included patient expectations, demographic factors (e.g. age, gender, nationality), socio‐economic factors (e.g. employment, education level) and health‐related factors (e.g. body mass index BMI, general health, mental health). The final prediction models were obtained using backward selection. The model's prognostic accuracy (Hosmer–Lemeshow X2, Nagelkerke's R2) and discriminative ability (area under the receiver operating curve AUC) were assessed, and the models were internally validated using bootstrapping.
Results
Poor physical health, high functional disability, low health‐related quality of life, high impact of pain experience, non‐Dutch nationality and decreasing pain were found to be predictive of high societal costs in all models, and were therefore considered robust. After internal validation, the models' fit was good, their explained variance was relatively low (≤14.1%) and their AUCs could be interpreted as moderate (≥0.71).
Conclusion
Future studies should focus on understanding the mechanisms associated with the identified predictors for high societal costs in order to design effective cost reduction initiatives.
Significance
Identifying low back pain patients who are at risk (risk stratification) of becoming high‐cost users and making appropriate initiatives could help in reducing high costs.
Objectives Depression is associated with considerable impairments in health-related quality-of-life. However, the relationship between different health states related to depression severity and ...utility scores is unclear. The aim of this study was to evaluate whether utility scores are different for various health states related to depression severity. Methods We gathered individual participant data from ten randomized controlled trials evaluating depression treatments. The UK EQ-5D and SF-6D tariffs were used to generate utility scores. We defined five health states that were proposed from American Psychiatric Association and National Institute for Clinical Excellence guidelines: remission, minor depression, mild depression, moderate depression, and severe depression. We performed multilevel linear regression analysis. Results We included 1629 participants in the analyses. The average EQ-5D utility scores for the five health states were 0.70 (95% CI 0.67-0.73) for remission, 0.62 (95% CI 0.58-0.65) for minor depression, 0.57 (95% CI 0.54-0.61) for mild depression, 0.52 (95%CI 0.49-0.56) for moderate depression, and 0.39 (95% CI 0.35-0.43) for severe depression. In comparison with the EQ-5D, the utility scores based on the SF-6D were similar for remission (EQ5D = 0.70 vs. SF-6D = 0.69), but higher for severe depression (EQ-5D = 0.39 vs. SF-6D = 0.55). Conclusions We observed statistically significant differences in utility scores between depression health states. Individuals with less severe depressive symptoms had on average statistically significant higher utility scores than individuals suffering from more severe depressive symptomatology. In the present study, EQ-5D had a larger range of values as compared to SF-6D.
Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence ...remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.
WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.
The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.
WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.
Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of ...cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations.
Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness.
In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to - 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively.
Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.
Chronic Low Back Pain (CLBP) is a heterogeneous condition with lack of diagnostic clarity. Therapeutic interventions show small effects. To improve outcomes by targeting interventions it is ...recommended to develop a triage system to surgical and non-surgical treatments based on treatment outcomes. The objective of the current study was to develop and internally validate prognostic models based on pre-treatment patient-reported profiles that identify patients who either respond or do not respond to two frequently performed treatments (lumbar spine surgery and multidisciplinary pain management program).
A consecutive cohort study in a secondary referral spine center was performed. The study followed the recommendations of the PROGRESS framework and was registered in the Dutch Trial Register (NTR5946). Data of forty-seven potential pre-consultation (baseline) indicators predicting 'response' or 'non-response' at one-year follow-up for the two treatments were obtained to develop and validate four multivariable logistic regression models. The source population consisted of 3,410 referred CLBP-patients. Two treatment cohorts were defined: elective 'spine surgery' (n = 217 6.4%) and multidisciplinary bio-psychosocial 'pain management program' (n = 171 5.0%). Main inclusion criteria were age ≥18, CLBP (≥6 months), and not responding to primary care treatment. The primary outcome was functional ability: 'response' (Oswestry Disability Index ODI ≤22) and 'non-response' (ODI ≥41).
Baseline indicators predictive of treatment outcome were: degree of disability (all models), ≥2 previous spine surgeries, psychosocial complaints, age (onset <20 or >50), and patient expectations of treatment outcomes. The explained variances were low for the models predicting response and non-response to pain management program (R2 respectively 23% and 26%) and modest for surgery (R2 30% and 39%). The overall performance was acceptable (c-index; 0.72-0.83), the model predicting non-response to surgery performed best (R2 = 39%; c-index = 0.83).
This study was the first to identify different patient-reported profiles that predict response to different treatments for CLBP. The model predicting 'non-response' to elective lumbar spine surgery performed remarkably well, suggesting that referrals of these patients to a spine surgeon could be avoided. After external validation, the patient-reported profiles could potentially enhance timely patient triage to the right secondary care specialist and improve decision-making between clinican and patient. This could lead to improved treatment outcomes, which results in a more efficient use of healthcare resources.
Transforaminal epidural injections with steroids (TESI) are increasingly being used in patients sciatica. The STAR (steroids against radiculopathy)-trial aimed to evaluate the (cost-) effectiveness ...of TESI in patients with acute sciatica (< 8 weeks). This article contains the economic evaluation of the STAR-trial.
Participants were randomized to one of three study arms: Usual Care (UC), that is oral pain medication with or without physiotherapy, n = 45); intervention group 1: UC and transforaminal epidural steroid injection (TESI) 1 ml of 0.5% Levobupivacaine and 1 ml of 40 mg/ml Methylprednisolone and intervention group 2: UC and transforaminal epidural injection (TEI) with 1 ml of 0,5% Levobupivacaine and 1 ml of 0.9% NaCl (n = 50). The primary effect measure was health-related quality of life. Secondary outcomes were pain, functioning, and recovery. Costs were measured from a societal perspective, meaning that all costs were included, irrespective of who paid or benefited. Missing data were imputed using multiple imputation, and bootstrapping was used to estimate statistical uncertainty.
None of the between-group differences in effects were statistically significant for any of the outcomes (QALY, back pain, leg pain, functioning, and global perceived effect) at the 26-weeks follow-up. The adjusted mean difference in total societal costs was €1718 (95% confidence interval CI: - 3020 to 6052) for comparison 1 (intervention group 1 versus usual care), €1640 (95%CI: - 3354 to 6106) for comparison 2 (intervention group 1 versus intervention group 2), and €770 (95%CI: - 3758 to 5702) for comparison 3 (intervention group 2 versus usual care). Except for the intervention costs, none of the aggregate and disaggregate cost differences were statistically significant. The maximum probability of all interventions being cost-effective compared to the control was low (< 0.7) for all effect measures.
These results suggest that adding TESI (or TEI) to usual care is not cost-effective compared to usual care in patients with acute sciatica (< 8 weeks) from a societal perspective in a Dutch healthcare setting.
Dutch National trial register: NTR4457 (March, 6th, 2014).
Purpose
Inconsistent results have been found on the impact of using crosswalks versus EQ-5D value sets on reimbursement decisions. We sought to further investigate this issue in a simulation study.
...Methods
Trial-based economic evaluation data were simulated for different conditions (depression, low back pain, osteoarthritis, cancer), severity levels (mild, moderate, severe), and effect sizes (small, medium, large). For all 36 scenarios, utilities were calculated using 3L and 5L value sets and crosswalks (3L to 5L and 5L to 3L crosswalks) for the Netherlands, the United States, and Japan. Utilities, quality-adjusted life years (QALYs), incremental QALYs, incremental cost-effectiveness ratios (ICERs), and probabilities of cost-effectiveness (pCE) obtained from values sets and crosswalks were compared.
Results
Differences between value sets and crosswalks ranged from −0.33 to 0.13 for utilities, from −0.18 to 0.13 for QALYs, and from −0.01 to 0.08 for incremental QALYs, resulting in different ICERs. For small effect sizes, at a willingness-to-pay of €20,000/QALY, the largest pCE difference was found for moderate cancer between the Japanese 5L value set and 5L to 3L crosswalk (difference = 0.63). For medium effect sizes, the largest difference was found for mild cancer between the Japanese 3L value set and 3L to 5L crosswalk (difference = 0.06). For large effect sizes, the largest difference was found for mild osteoarthritis between the Japanese 3L value set and 3L to 5L crosswalk (difference = 0.08).
Conclusion
The use of crosswalks instead of EQ-5D value sets can impact cost–utility outcomes to such an extent that this may influence reimbursement decisions.
To assess the barriers and facilitators associated with upscaling the Transmural Trauma Care Model (TTCM), a multidisciplinary and patient-centred transmural rehabilitation care model.
...Semi-structured interviews were conducted with eight trauma surgeons, eight hospital-based physiotherapists, eight trauma patients, and eight primary care physiotherapists who were part of a trauma rehabilitation network. Audio recordings of the interviews were made and transcribed verbatim. Data were analysed using a framework method based on the "constellation approach". Identified barriers and facilitators were grouped into categories related to structure, culture, and practice.
Various barriers and facilitators to upscaling were identified. Under structure, barriers and facilitators belonged to one of five themes: "financial structure", "communication structure", "physical structures and resources", "rules and regulations", and "organisation of the network". Under culture, the five themes were "commitment", "job satisfaction", "acting as a team", "quality and efficiency of care", and "patients' experience". Under practice, the two themes were "practical issues at the outpatient clinic" and "knowledge gained".
The success of upscaling the TTCM differed across hospitals and settings. The most important prerequisites for successfully upscaling the TTCM were adequate financial support and presence of "key actors" within an organisation who felt a sense of urgency for change and/or expected the intervention to increase their job satisfaction.
NL8163 The Netherlands National Trial Register, date of registration 16-11-2019.
To investigate the effectiveness of a 3-year worksite lifestyle intervention on cardiovascular metrics and to study whether outcomes are influenced by baseline subclinical atherosclerosis (SA) by ...non-invasive imaging.
A randomized controlled trial was performed to compare a lifestyle intervention with standard of care in asymptomatic middle-aged subjects, stratified by SA. The intervention consisted of nine motivational interviews during the first year, followed by three further sessions between Years 1 and 3. The primary outcome was the change in a pre-specified adaptation of the Fuster-BEWAT score (Blood pressure, Exercise, Weight, Alimentation, and Tobacco) between baseline and follow-up Years 1-3. A total of 1020 participants (mean age 50 ± 4 years) were enrolled, of whom 510 were randomly assigned to the intervention and 510 to the control group. The baseline adapted Fuster-BEWAT score was 16.2 ± 3.7 points in the intervention group and 16.5 ± 3.5 points in the control group. At Year 1, the score improved significantly in intervention participants compared with controls estimate 0.83 (95% CI 0.52-1.15) points. However, intervention effectiveness decreased to non-significant levels at Year 3 0.24 (95% CI -0.10 to 0.59) points. Over the 3-year period, the intervention was effective in participants having low baseline SA 0.61 (95% CI 0.30-0.93) points but not in those with high baseline SA 0.19 (95% CI -0.26 to 0.64) points.
In middle-aged asymptomatic adults, a lifestyle intervention was associated with a significant improvement in cardiovascular health and behavioural metrics. The effect attenuated after 1 year as the intensity of the intervention was reduced.
ClinicalTrials.gov (NCT02561065).
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