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Contains fulltext : 293486.pdf (Publisher’s version ) (Open Access) 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 (R(2)), 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 (R(2) = 0.43; RMSE = 0.22; MAE = 0.03; 95% LA = -0.40 to 0.47) compared with the Non-peLI (R(2) = 0.07; RMSE = 0.29; MAE = -0.15; 95% LA = -0.63 to 0.34) and OLR (R(2) = 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. 01 juni 2023

Introduction For the analysis of clinical effects, multiple imputation (MI) of missing data were shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to trial-based economic evaluations. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost and effect data. Methods Two-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10, 25, and 50% missing data in follow-up costs and effects, assuming a Missing At Random (MAR) mechanism. Six different strategies were compared using empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). These strategies were: LLM alone (LLM) and MI with LLM (MI-LLM), and, as reference strategies, mean imputation with LLM (M-LLM), seemingly unrelated regression alone (SUR-CCA), MI with SUR (MI-SUR), and mean imputation with SUR (M-SUR). Results For costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, SUR-CCA, and M-SUR, with smaller EBs and RMSEs as well as CRs closers to nominal levels. However, even though LLM, MI-LLM and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 and 25% missing data. At 50% missing data, all strategies resulted in relatively high EBs and RMSEs for costs. Conclusion LLM should be combined with MI when analyzing trial-based economic evaluation data. MI-SUR is more efficient and can also be used, but then an average intervention effect over time cannot be estimated.

IntroductionFor the analysis of clinical effects, multiple imputation (MI) of missing data was shown to be unnecessary when using longitudinal linear mixed-models (LLM). It remains unclear whether this also applies to cost estimates from trial-based economic evaluations, that are generally right-skewed. Therefore, this study aimed to assess whether MI is required prior to LLM when analyzing longitudinal cost-effectiveness data.MethodsTwo-thousand complete datasets were simulated containing five time points. Incomplete datasets were generated with 10 percent, 25 percent, and 50 percent missing data in costs and effects, assuming a Missing At Random (MAR) mechanism. Statistical performance of six different methodological strategies was compared in terms of empirical bias (EB), root-mean-squared error (RMSE), and coverage rate (CR). Six strategies were compared: (i) LLM (LLM), (ii) MI prior to LLM (MI-LLM), (iii) mean imputation prior to LLM (M-LLM), (iv) complete-case analysis prior to seemingly unrelated regression (CCA-SUR), (v) MI prior to SUR (MI-SUR), and (vi) mean imputation prior to SUR (M-SUR). To evaluate the impact on the probability of cost-effectiveness at different willingness-to-pay [WTPs] thresholds, cost-effectiveness analyses were performed by applying the six strategies to two empirical datasets with 9% and 50% of missing data, respectively.ResultsFor costs and effects, LLM, MI-LLM, and MI-SUR performed better than M-LLM, CCA-SUR, and M-SUR, as indicated by smaller EBs and RMSEs, as well as CRs closer to the nominal levels of 0.95. However, even though LLM, MI-LLM, and MI-SUR performed equally well for effects, MI-LLM and MI-SUR were found to perform better than LLM for costs at 10 percent and 25 percent missing data. At 50 percent missing data, all strategies resulted in relatively high EBs and RMSEs for costs. In both empirical datasets, LLM, MI-LLM, and MI-SUR all resulted in similar probabilities of cost-effectiveness at different WTPs.ConclusionsWhen opting for using LLM for analyzing trial-based economic evaluation data, researchers are advised to multiply impute missing values first. Otherwise, MI-SUR may also be used.

Purpose Based on current scientific evidence and best practice, the first Dutch multidisciplinary practice guideline for occupational health professionals was developed to stimulate prevention and enhance work participation in patients with low back pain (LBP) and lumbosacral radicular syndrome (LRS). Methods A multidisciplinary working group with health care professionals, a patient representative and researchers developed the recommendations after systematic review of evidence about (1) Risk factors, (2) Prevention, (3) Prognostic factors and (4) Interventions. Certainty of the evidence was rated with GRADE and the Evidence to Decision (EtD) framework was used to formulate recommendations. High or moderate certainty resulted in a recommendation “to advise”, low to very low in a recommendation “to consider”, unless other factors in the framework decided differently. Results An inventory of risk factors should be considered and an assessment of prognostic factors is advised. For prevention, physical exercises and education are advised, besides application of the evidence-based practical guidelines “lifting” and “whole body vibration”. The stepped-care approach to enhance work participation starts with the advice to stay active, facilitated by informing the worker, reducing workload, an action plan and a time-contingent increase of work participation for a defined amount of hours and tasks. If work participation has not improved within 6 weeks, additional treatments should be considered based on the present risk and prognostic factors: (1) physiotherapy or exercise therapy; (2) an intensive workplace-oriented program; or (3) cognitive behavioural therapy. After 12 weeks, multi-disciplinary (occupational) rehabilitation therapy need to be considered. Conclusions Based on systematic reviews and expert consensus, the good practice recommendations in this guideline focus on enhancing work participation among workers with LBP and LRS using a stepped-care approach to complement existing guidelines focusing on recovery and daily functioning.

Sciatica impacts on the ability to work and may lead to a reduced return to work. This study reviewed and summarised prognostic factors of work participation in patients who received conservative or surgical treatment for clinically diagnosed sciatica. We searched MEDLINE, CINAHL, EMBASE and PsycINFO until January 2018. Cohort studies, using a measure of work participation as outcome, were included. Two independent reviewers performed study inclusion and used the Quality In Prognosis Studies tool for risk of bias assessment and GRADE to rate the quality of the evidence. Based on seven studies describing six cohorts (n=1408 patients) that assessed 21 potential prognostic factors, favourable factors for return to work (follow-up ranging from 3 months to 10 years) included younger age, better general health, less low back pain or sciatica bothersomeness, better physical function, negative straight leg raise-test, physician expecting surgery to be beneficial, better pain coping, less depression and mental stress, less fear of movement and low physical work load. Study results could not be pooled. Using GRADE, the quality of the evidence ranged from moderate to very low, with downgrading mainly for a high risk of bias and imprecision. Several prognostic factors like pain, disability and psychological factors were identified and reviewed, and these could be targeted using additional interventions to optimise return to work. PROSPERO registration number: CRD42016042497.

Background: 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. Methods: 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. Results: In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to -7,502€/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.Conclusions: 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.

Background 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. Methods 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. Results 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. Conclusions 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.

Introduction Sciatica is usually self-limiting with pain and disability decreasing over time, but not all patients fully recover. Prognostic evidence could assist clinicians to better define high risk groups and inform both clinicians and patients with regard to counselling and treatment choices to promote return to work. The objective of this study was to review and summarise prognostic factors of work participation in patients with sciatica. Methods We searched MEDLINE, CINAHL, EMBASE and PsycINFO till May 2016. Cohort studies, using a measure of work participation as outcome, were included. We used the QUIPS tool for risk of bias assessment and GRADE to rate the quality of the evidence. Results Based on five studies describing four cohorts (n=983 patients) that assessed 19 potential prognostic factors, favourable factors for return to work at long term-term follow up (up to 10 years) included: younger age, better general health, less low back pain or sciatica bothersomeness, better physical function, positive SLR-test, a physician expecting surgery to be beneficial, better pain coping, less depression and mental stress, low physical work load. Study results could not be pooled. Using GRADE, the quality of the evidence ranged from moderate to very low. Discussion Five studies describing four cohorts identified a wide range of factors: general health, pain and disability, psychological factors and work related factors. Although the number of studies was low and the quality of evidence ranged from moderate to very low, prognostic (modifiable) factors may be used to assist clinicians and occupational healthcare professionals in guiding high risk patients and consider referral for additional care or vocational rehabilitation, or in managing patients’ expectations regarding return to work.

QUESTION: Is referral for early rehabilitation after lumbar disc surgery effective and cost-effective compared to no referral?DESIGN: Multicentre, randomised, controlled trial, and economic evaluation with concealed allocation and intention-to-treat-analysis.PARTICIPANTS: Adults who underwent discectomy for a herniated lumbar disc, confirmed by magnetic resonance imaging, and signs of nerve root compression corresponding to the herniation level.INTERVENTION: Early rehabilitation (exercise therapy) for 6 to 8 weeks, versus no referral, immediately after discharge.OUTCOME MEASURES: In line with the recommended core outcome set, the co-primary outcomes were: functional status (Oswestry Disability Index); leg and back pain (numerical rating scale 0 to 10); global perceived recovery (7-point Likert scale); and general physical and mental health (SF12), assessed 3, 6, 9, 12 and 26 weeks after surgery. The outcomes for the economic evaluation were quality of life and costs, measured at 6, 12 and 26 weeks after surgery.RESULTS: There were no clinically relevant or statistically significant overall mean differences between rehabilitation and control for any outcome adjusted for baseline characteristics: global perceived recovery (OR 1.0, 95% CI 0.6 to 1.7), functional status (MD 1.5, 95% CI -3.6 to 6.7), leg pain (MD 0.1, 95% CI -0.7 to 0.8), back pain (MD 0.3, 95% CI -0.3 to 0.9), physical health (MD -3.5, 95% CI -11.3 to 4.3), and mental health (MD -4.1, 95% CI -9.4 to 1.3). After 26 weeks, there were no significant differences in quality-adjusted life years (MD 0.01, 95% CI -0.02 to 0.04 points) and societal costs (MD -€527, 95% CI -2846 to 1506). The maximum probability for the intervention to be cost-effective was 0.75 at a willingness-to-pay of €32 000/quality-adjusted life year.CONCLUSION: Early rehabilitation after lumbar disc surgery was neither more effective nor more cost-effective than no referral.TRIAL REGISTRATION: Netherlands Trial Register NTR3156. [Oosterhuis T, Ostelo RW, van Dongen JM, Peul WC, de Boer MR, Bosmans JE, Vleggeert-Lankamp CL, Arts MP, van Tulder MW (2017) Early rehabilitation after lumbar disc surgery is not effective or cost-effective compared to no referral: a randomised trial and economic evaluation. Journal of Physiotherapy XX: XX-XX].

OBJECTIVE: The purpose of this study was to evaluate changes in methodological quality and sample size in randomized controlled trials (RCTs) of spinal manipulative therapy (SMT) for neck and low back pain over a specified period. A secondary purpose was to make recommendations for improvement for future SMT trials based upon our findings. METHODS: Randomized controlled trials that examined the effect of SMT in adults with neck and/or low back pain and reported at least 1 patient-reported outcome measure were included. Studies were identified from recent Cochrane reviews of SMT, and an update of the literature was conducted (March 2013). Risk of bias was assessed using the 12-item criteria recommended by the Cochrane Back Review Group. In addition, sample size was examined. The relationship between the overall risk of bias and sample size over time was evaluated using regression analyses, and RCTs were grouped into periods (epochs) of approximately 5 years. RESULTS: In total, 105 RCTs were included, of which 41 (39%) were considered to have a low risk of bias. There is significant improvement in the mean risk of bias over time (P < .05), which is the most profound for items related to selection bias and, to a lesser extent, attrition and selective outcome reporting bias. Furthermore, although there is no significant increase in sample size over time (overall P = .8), the proportion of studies that performed an a priori sample size calculation is increasing statistically (odds ratio, 2.1; confidence interval, 1.5-3.0). Sensitivity analyses suggest no appreciable difference between studies for neck or low back pain for risk of bias or sample size. CONCLUSION: Methodological quality of RCTs of SMT for neck and low back pain is improving, whereas overall sample size has shown only small and nonsignificant increases. There is an increasing trend among studies to conduct sample size calculations, which relate to statistical power. Based upon these findings, 7 areas of improvement for future SMT trials are suggested.

AIM: To identify factors predictive of function 12 months after a fall and emergency department (ED) presentation. METHODS: This was a prospective cohort study with 608 older fallers. After presentation and discharge from the ED, a baseline assessment was initially undertaken and then repeated after 12 months. The Human Activity Profile Adjusted Activity Score (HAP-AAS) at the 12-month follow-up assessment was the functional outcome measure. RESULTS: Over the follow-up period, 37.3% (95% CI 33.4, 41.2) of participants declined in their HAP-AAS score. Increased age, pre-index fall functional impairment, poorer mobility/balance, and sustaining falls and severe injuries over the 12-month follow-up period were some of the factors predictive of a lower HAP-AAS score. CONCLUSION: This study highlights the importance of preventing falls in the 12 months after discharge from an ED. Some of the factors identified as being predictive of lower function are the same as those previously found to be predictive of falls. Language: en

To identify factors predictive of function 12 months after a fall and emergency department (ED) presentation.This was a prospective cohort study with 608 older people who had a fall. After presentation and discharge from the ED, a baseline assessment was initially undertaken and then repeated after 12 months. The Human Activity Profile Adjusted Activity Score (HAP-AAS) at the 12-month follow-up assessment was the functional outcome measure.Over the follow-up period, 37.3% (95% CI 33.4, 41.2) of participants declined in their HAP-AAS score. Increased age, pre-index fall functional impairment, poorer mobility/balance, and sustaining falls and severe injuries over the 12-month follow-up period were some of the factors predictive of a lower HAP-AAS score.This study highlights the importance of preventing falls in the 12 months after discharge from an ED. Some of the factors identified as being predictive of lower function are the same as those previously found to be predictive of falls.

Background Several rehabilitation programmes are available for individuals after lumbar disc surgery. Objectives To determine whether active rehabilitation after lumbar disc surgery is more effective than no treatment, and to describe which type of active rehabilitation is most effective. This is the second update of a Cochrane Review first published in 2002. First, we clustered treatments according to the start of treatment. 1. Active rehabilitation that starts immediately postsurgery. 2. Active rehabilitation that starts four to six weeks postsurgery. 3. Active rehabilitation that starts longer than 12 months postsurgery. For every cluster, the following comparisons were investigated. A. Active rehabilitation versus no treatment, placebo or waiting list control. B. Active rehabilitation versus other kinds of active rehabilitation. C. Specific intervention in addition to active rehabilitation versus active rehabilitation alone. Search methods We searched CENTRAL (2013, Issue 4) and MEDLINE, EMBASE, CINAHL, PEDro and PsycINFO to May 2013. Selection criteria We included only randomised controlled trials (RCTs). Data collection and analysis Pairs of review authors independently assessed studies for eligibility and risk of bias. Meta-analyses were performed if studies were clinically homogeneous. The GRADE approach was used to determine the overall quality of evidence. Main results In this update, we identified eight new studies, thereby including a total of 22 trials (2503 participants), 10 of which had a low risk of bias. Most rehabilitation programmes were assessed in only one study. Both men and women were included, and overall mean age was 41.4 years. All participants had received standard discectomy, microdiscectomy and in one study standard laminectomy and (micro)discectomy. Mean duration of the rehabilitation intervention was 12 weeks; eight studies assessed six to eight-week exercise programmes, and eight studies assessed 12 to 13-week exercise programmes. Programmes were provided in primary and secondary care facilities and were started immediately after surgery (n = 4) or four to six weeks (n = 16) or one year after surgery (n = 2). In general, the overall quality of the evidence is low to very low. Rehabilitation programmes that started immediately after surgery were not more effective than their control interventions, which included exercise. Low- to very low-quality evidence suggests that there were no differences between specific rehabilitation programmes (multidisciplinary care, behavioural graded activity, strength and stretching) that started four to six weeks postsurgery and their comparators, which included some form of exercise. Low-quality evidence shows that physiotherapy from four to six weeks postsurgery onward led to better function than no treatment or education only, and that multidisciplinary rehabilitation co-ordinated by medical advisors led to faster return to work than usual care. Statistical pooling was performed only for three comparisons in which the rehabilitation programmes started four to six weeks postsurgery: exercise programmes versus no treatment, high- versus low-intensity exercise programmes and supervised versus home exercise programmes. Very low-quality evidence (five RCTs, N = 272) shows that exercises are more effective than no treatment for pain at short-term follow-up (standard mean difference (SMD) -0.90; 95% confidence interval (CI) -1.55 to -0.24), and low-quality evidence (four RCTs, N = 252) suggests that exercises are more effective for functional status on short-term follow-up (SMD -0.67; 95% CI -1.22 to -0.12) and that no difference in functional status was noted on long-term follow-up (three RCTs, N = 226; SMD -0.22; 95% CI -0.49 to 0.04). None of these studies reported that exercise increased the reoperation rate. Very low-quality evidence (two RCTs, N = 103) shows that high-intensity exercise programmes are more effective than low-intensity exercise programmes for pain in the short term (weighted mean difference (WMD) -10.67; 95% CI -17.04 to -4.30), and low-quality evidence (two RCTs, N = 103) shows that they are more effective for functional status in the short term (SMD -0.77; 95% CI -1.17 to -0.36). Very low-quality evidence (four RCTs, N = 154) suggests no significant differences between supervised and home exercise programmes for short-term pain relief (SMD -0.76; 95% CI -2.04 to 0.53) or functional status (four RCTs, N = 154; SMD -0.36; 95% CI -0.88 to 0.15). Authors' conclusions Considerable variation was noted in the content, duration and intensity of the rehabilitation programmes included in this review, and for none of them was high- or moderate-quality evidence identified. Exercise programmes starting four to six weeks postsurgery seem to lead to a faster decrease in pain and disability than no treatment, with small to medium effect sizes, and high-intensity exercise programmes seem to lead to a slightly faster decrease in pain and disability than is seen with low-intensity programmes, but the overall quality of the evidence is only low to very low. No significant differences were noted between supervised and home exercise programmes for pain relief, disability or global perceived effect. None of the trials reported an increase in reoperation rate after first-time lumbar surgery. High-quality randomised controlled trials are strongly needed.

Background: Patients who undergo lumbar disc surgery for herniated discs, are advocated two different postoperative management strategies: a watchful waiting policy, or referral for rehabilitation immediately after discharge from the hospital. A direct comparison of the effectiveness and cost-effectiveness of these two strategies is lacking. Methods/Design. A randomised controlled trial will be conducted with an economic evaluation alongside to assess the (cost-) effectiveness of rehabilitation after lumbar disc surgery. Two hundred patients aged 18-70 years with a clear indication for lumbar disc surgery of a single level herniated disc will be recruited and randomly assigned to either a watchful waiting policy for first six weeks or exercise therapy starting immediately after discharge from the hospital. Exercise therapy will focus on resumption of activities of daily living and return to work. Therapists will tailor the intervention to the individual patient's needs. All patients will be followed up by the neurosurgeon six weeks postoperatively. Main outcome measures are: functional status, pain intensity and global perceived recovery. Questionnaires will be completed preoperatively and at 3, 6, 9, 12 and 26 weeks after surgery. Data will be analysed according to the intention-to-treat principle, using a linear mixed model for continuous outcomes and a generalised mixed model for dichotomous outcomes. The economic evaluation will be performed from a societal perspective. Discussion. The results of this trial may lead to a more consistent postoperative strategy for patients who will undergo lumbar disc surgery. Trial registration. Netherlands Trial Register: NTR3156. © 2013 Oosterhuis et al.; licensee BioMed Central Ltd.