Cost-effectiveness of a stepped care program to prevent depression among primary care patients with diabetes mellitus type 2 and/or coronary heart disease and subthreshold depression in comparison with usual care.

BACKGROUND: Patients with diabetes mellitus type 2 (DM2) and/or coronary heart disease (CHD) are at high risk to develop major depression. Preventing incident major depression may be an important tool in reducing the personal and societal burden of depression. The aim of the current study was to assess the cost-effectiveness of a stepped care program to prevent major depression (Step-Dep) in diabetes mellitus type 2 and/or coronary heart disease patients with subthreshold depression in comparison with usual care. METHODS: An economic evaluation with 12 months follow-up was conducted alongside a pragmatic cluster-randomized controlled trial from a societal perspective. Participants received care as usual (n = 140) or Step-Dep (n = 96) which consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to a general practitioner. Primary outcomes were quality-adjusted life years (QALYs) and cumulative incidence of major depression. Costs were measured every 3 months. Missing data was imputed using multiple imputation. Uncertainty around cost-effectiveness outcomes was estimated using bootstrapping and presented in cost-effectiveness planes and acceptability curves. RESULTS: There were no significant differences in QALYs or depression incidence between treatment groups. Secondary care costs (mean difference €1644, 95% CI €344; €3370) and informal care costs (mean difference €1930, 95% CI €528; €4089) were significantly higher in the Step-Dep group than in the usual care group. The difference in total societal costs (€1001, 95% CI €-3975; €6409) was not statistically significant. The probability of the Step-Dep intervention being cost-effective was low, with a maximum of 0.41 at a ceiling ratio of €30,000 per QALY gained and 0.32 at a ceiling ratio of €0 per prevented case of major depression. CONCLUSIONS: The Step-Dep intervention is not cost-effective compared to usual care in a population of patients with DM2/CHD and subthreshold depression. Therefore, widespread implementation cannot be recommended. TRIAL REGISTRATION: The trial was registered in the Netherlands Trial Register ( NTR3715 ).

Cryoneurolysis' outcome on pain experience (COPE) in patients with low-back pain: study protocol for a single-blinded randomized controlled trial.

BACKGROUND: Low-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome. METHODS: A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity ≥ 50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is the patients' impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months (T6). DISCUSSION: This study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population. TRIAL REGISTRATION: The trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145 .

Reduction of routine use of radiography in patients with ankle fractures leads to lower costs and has no impact on clinical outcome: an economic evaluation.

BACKGROUND: To evaluate the cost-effectiveness of a reduction in the number of routine radiographs in the follow-up of patients with ankle fractures. METHODS: We performed an economic evaluation alongside the multicentre, randomised WARRIOR trial. Participants were randomised to a reduced imaging follow-up protocol (i.e. radiographs at week 6 and 12 follow-up obtained on clinical indication) or usual care (i.e. routine radiography at weeks 6 and 12). The Olerud & Molander Ankle Score (OMAS) was used to assess ankle function and the EQ-5D-3L was used to estimate Quality-Adjusted Life Years (QALYs). Costs and resource use were assessed using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation was used for missing data, and data were analysed using seemingly unrelated regression analysis and bootstrapping. RESULTS: In total, 246 patients had data available for analysis (reduced imaging = 118; usual care = 128). Fewer radiographs were obtained in the reduced imaging group (median = 4) compared with the usual-care group (median = 5). Functional outcome was comparable in both groups. The difference in QALYs was - 0.008 (95% CI:-0.06 to 0.04) and the difference in OMAS was 0.73 (95% CI:-5.29 to 6.76). Imaging costs were lower in the reduced imaging group (-€48; 95% CI:- €72 to -€25). All other cost categories did not statistically differ between the groups. The probability of the reduced imaging protocol being cost-effectiveness was 0.45 at a wiliness-to-pay of €20,000 per QALY. CONCLUSIONS: Reducing the number of routine follow-up radiographs has a low probability of being cost-effective compared with usual care. Functional outcome, health-related quality of life and societal costs were comparable in both groups, whereas imaging costs were marginally lower in the reduced imaging group. Given this, adherence to a reduced imaging follow-up protocol for those with routine ankle fractures can be followed without sacrificing quality of care, and may result in reduced costs. TRIAL REGISTRATION: The trial was registered on 26-05-2014 in the Netherlands Trial Registry, with reference number NL4477 ( www.trialregister.nl/trial/4477 ).

Omitting Routine Radiography of Traumatic Ankle Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes: The WARRIOR Trial: A Multicenter Randomized Controlled Trial.

BACKGROUND: The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes. METHODS: This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models. RESULTS: Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [ß], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar. CONCLUSIONS: Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

The longitudinal relationships between pain severity and disability versus health-related quality of life and costs among chronic low back pain patients.

PURPOSE: Previous studies found higher levels of pain severity and disability to be associated with higher costs and lower health-related quality of life. However, these findings were based on cross-sectional data and little is known about the longitudinal relationships between pain severity and disability versus health-related quality of life and costs among chronic low back pain patients. This study aims to cover this knowledge gap by exploring these longitudinal relationships in a consecutive cohort. METHODS: Data of 6316 chronic low back pain patients were used. Measurements took place at 3, 6, 9, and 12 months. Pain severity (Numeric pain rating scale; range: 0-100), disability (Oswestry disability index; range: 0-100), health-related quality of life (EQ-5D-3L: range: 0-1), societal and healthcare costs (cost questionnaire) were measured. Using linear generalized estimating equation analyses, longitudinal relationships were explored between: (1) pain severity and health-related quality of life, (2) disability and health-related quality of life, (3) pain severity and societal costs, (4) disability and societal costs, (5) pain severity and healthcare costs, and (6) disability and healthcare costs. RESULTS: Higher pain and disability levels were statistically significantly related with poorer health-related quality of life (pain intensity: - 0.0041; 95% CI - 0.0043 to - 0.0039; disability: - 0.0096; 95% CI - 0.0099 to - 0.0093), higher societal costs (pain intensity: 7; 95% CI 5 to 8; disability: 23; 95% CI 20 to 27) and higher healthcare costs (pain intensity: 3; 95% CI 2 to 4; disability: 9; 95% CI 7 to 11). CONCLUSION: Pain and disability were longitudinally related to health-related quality of life, societal costs, and healthcare costs. Disability had a stronger association with all outcomes compared to pain.

Do socio-demographic characteristics and/or health status explain the magnitude of differences between patient and general public utility values? A chronic low back pain patients case study.

BACKGROUND: Utility values can be obtained from different respondent groups, including patients and members of the general public. Evidence suggests that patient values are typically higher than general public values. This study explores whether the magnitude of disagreement between both values can be explained by socio-demographic characteristics and/or health status. METHODS: Data of 5037 chronic low back pain patients were used. Self-reported EQ-VAS was employed as a proxy of patients' preference for their own health state. General public values for the patients' EQ-5D-3L health states were obtained using the Dutch VAS-based tariff. The difference between patient and general public values was assessed using a paired t-test. Subsequently, this difference was used as a dependent variable and regressed upon dummy variables of socio-demographic and health status characteristics. Coefficients represented age, gender, education level, social support, back pain intensity, leg pain intensity, functional status, comorbidities, catastrophizing, and treatment expectations. RESULTS: Patient values were higher than general public values (0.069; 95%CI:0.063-0.076). The magnitude of disagreement between both values was associated with age, gender, education level, social support, functional status, and comorbidities, but not with back pain intensity, leg pain intensity, catastrophizing, and treatment expectations. CONCLUSIONS: Patients were found to value their own health status higher than members of the general public. The magnitude of disagreement between both values was found to differ by various socio-demographic and/or health status characteristics. This suggest that patient characteristics account for a relevant fraction of the identified disagreements between patient and general public values, and that mechanisms thought to be responsible for these disagreements, such as adaptation and response shift, have a differential impact across patient sub-groups.

Omitting Routine Radiography of Traumatic Distal Radial Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes.

BACKGROUND: Routine radiography in the follow-up of distal radial fractures is common practice, although its usefulness is disputed. The aim of this study was to determine whether the number of radiographs in the follow-up period can be reduced without resulting in worse patient outcomes. METHODS: In this multicenter, prospective, randomized controlled trial with a non-inferiority design, patients ≥18 years old with a distal radial fracture could participate. They were randomized between a regimen with routine radiographs at 6 and 12 weeks of follow-up (usual care) and a regimen without routine radiographs at those time points (reduced imaging). Randomization was performed using an online registration and randomization program. The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) score. Secondary outcomes included the Patient-Rated Wrist/Hand Evaluation (PRWHE) score, health-related quality of life, pain, and complications. Outcomes were assessed at baseline and after 6 weeks, 3 months, 6 months, and 1 year of follow-up. Data were analyzed using mixed models. Neither the patients nor the health-care providers were blinded. RESULTS: Three hundred and eighty-six patients were randomized, and 326 of them were ultimately included in the analysis. The DASH scores were comparable between the usual-care group (n = 166) and the reduced-imaging group (n = 160) at all time points as well as overall. The adjusted regression coefficient for the DASH scores was 1.5 (95% confidence interval [CI] = -1.8 to 4.8). There was also no difference between the groups with respect to the overall PRWHE score (adjusted regression coefficient, 1.4 [95% CI = -2.4 to 5.2]), quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) (-0.02 [95% CI = -0.05 to 0.01]), pain at rest as measured with a visual analog scale (VAS) (0.1 [95% CI = -0.2 to 0.5]), or pain when moving (0.3 [95% CI = -0.1 to 0.8]). The complication rate was similar in the reduced imaging group (11.3%) and the usual-care group (11.4%). Fewer radiographs were made for the participants in the reduced-imaging group (median, 3 versus 4; p < 0.05). CONCLUSIONS: This study shows that omitting routine radiography after the initial 2 weeks of follow-up for patients with a distal radial fracture does not affect patient-reported outcomes or the risk of complications compared with usual care. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

The value of radiography in the follow-up of extremity fractures: a systematic review.

BACKGROUND: The added value of routine radiography in the follow-up of extremity fractures is unclear. The aim of this systematic review was to create an overview of radiography use in extremity fracture care and the consequences of these radiographs for the treatment of patients with these fractures. MATERIALS AND METHODS: Studies were included if they reported on the use of radiography in the follow-up of extremity fractures and on its influence on treatment strategy, clinical outcome, or complications. A comprehensive search of electronic databases (i.e., PubMed, Embase, and Cochrane) was performed to identify relevant studies. Methodological quality was assessed with the Newcastle-Ottawa scale for cohort studies. Level of evidence was assessed using GRADE. The search, quality appraisal, and data extraction were performed independently by two researchers. RESULTS: Eleven studies were included. All studies were retrospective cohorts. Of these, only two used a comparative design. Two of the included studies described fractures of both the upper and lower extremities, four studies concerned fractures of the lower extremity only, and five studies focused on fractures of the upper extremity. Pooling of data was not performed because of clinical heterogeneity. Eight studies reported on a change in treatment strategy related to radiography. Percentages ranged from 0 to 2.6%. The overall results indicated that radiographs in the follow-up of extremity fractures seldom alter treatment strategy, that the vast majority of follow-up radiographs are obtained without a clinical indication and that detection of a complication on a radiograph, in the absence of clinical symptoms, is unlikely. All included studies were regarded of a 'very low' level using GRADE. CONCLUSIONS: Based on current literature, the added value of routine radiography in the follow-up of extremity fractures seems limited. Results, however, should be interpreted with care, considering that available evidence is of a low level.

Long-term trajectories of patients with neck pain and low back pain presenting to chiropractic care: A latent class growth analysis.

BACKGROUND: Information on the course of neck pain (NP) and low back pain (LBP) typically relies on data collected at few time intervals during a period of up to 1 year. METHODS: In this prospective, multicentre practice-based cohort study, patients consulting a chiropractor responded weekly for 52 weeks to text messages on their cell phones. Data from 448 patients (153 NP, 295 LBP) who had returned at least one set of answers in the first 26 weeks were used. Outcome measures were pain intensity (VAS) and functional outcome, assessed using four different questions: pain intensity, limitation in activities of daily living (ADL), number of days with pain in the previous week and number of days limited in ADL. Distinct patterns of pain were analysed with quadratic latent class growth analysis. RESULTS: The final model was a 4-class model for NP and LBP. The 'recovering from mild baseline pain' is most common (76.3% of NP patients/58.3% of LBP patients) followed by the 'recovering from severe baseline pain' class (16.3% NP/29.8% LBP). They follow similar trajectories when considered over a period of 6 months. Pain at baseline, duration of complaints, functional status, limitations in ADL and the score on psychosocial scales were the variables that most contributed to distinguish between groups. CONCLUSIONS: Most patients with NP or LBP presenting in chiropractic care show a trajectory of symptoms characterized by persistent or fluctuating pain of low or medium intensity. Only a minority either experience a rapid complete recovery or develop chronic severe pain. SIGNIFICANCE: Ninety percentage of patients with neck pain or low back pain presenting to chiropractors have a 30% improvement within 6 weeks and then show a trajectory of symptoms characterized by persistent or fluctuating pain of low or medium intensity. Only a minority either experience a rapid complete recovery or develop chronic severe pain.

Cost-effectiveness of the psycho-educational blended (group and online) intervention HypoAware compared with usual care for people with Type 1 and insulin-treated Type 2 diabetes with problematic hypoglycaemia: analyses of a cluster-randomized controlled trial.

AIMS: To evaluate the cost-effectiveness of HypoAware, a blended (group and online) psycho-educational intervention based on the evidence-based Blood Glucose Awareness Training, in comparison with usual care in people with Type 1 and Type 2 diabetes with a high risk of severe hypoglycaemia. METHODS: We performed an economic evaluation, from a societal and healthcare perspective, that used data from a 6-month, multicentre, cluster-randomized controlled trial (n = 137). RESULTS: The proportion of people with at least one severe hypoglycaemic event per 6 months was 0.22 lower (95% CI -0.39 to -0.06) and the proportion of people with impaired hypoglycaemia awareness was 0.16 lower (95% CI -0.34 to 0.02) in the HypoAware group. There was no difference in quality-adjusted life-years (-0.0; 95% CI -0.05 to 0.05). The mean total societal costs in the HypoAware group were EUR708 higher than in the usual care group (95% CI -951 to 2298). The mean incremental cost per severe hypoglycaemic event prevented was EUR2,233. At a willingness-to-pay threshold of EUR20,000 per event prevented, the probability that HypoAware was cost-effective in comparison with usual care was 54% from a societal perspective and 55% from a healthcare perspective. For quality-adjusted life-years the incremental cost-effectiveness ratio was EUR119,360/quality-adjusted life-year gained and the probability of cost-effectiveness was low at all ceiling ratios. CONCLUSIONS: Based on the present study, we conclude that HypoAware is not cost-effective compared to usual care. Further research in less well-resourced settings and more severely affected patients is warranted. (Clinical Trials Registry no: Dutch Trial Register NTR4538.).

The cost-effectiveness and return-on-investment of a combined social and physical environmental intervention in office employees.

This study explored the cost-effectiveness and return-on-investment of a combined social and physical environmental worksite health promotion program compared with usual practice, and of both intervention conditions separately. Participants were randomized to the combined intervention (n = 92), social environmental intervention (n = 118), physical environmental intervention (n = 96), or control group (n = 106). The social environmental intervention consisted of group motivational interviewing and the physical environmental intervention of workplace modifications. Both interventions were aimed at improving physical activity and relaxation. Effects included need for recovery (NFR), general vitality and job satisfaction. Cost-effectiveness analyses were performed from the societal and employer's perspective, and return-on-investment analyses from the employer's perspective. Compared with usual practice, the combined intervention was significantly more effective in improving NFR (-8.4;95% CI:-14.6;-2.2) and significantly more expensive to the employer (3102; 95%CI:598;5969). All other between-group differences were non-significant. For NFR, the combined intervention became the preferred option at willingness-to-pays of ≥€170/point improvement (society) and ≥€300/point improvement (employer). For general vitality and job satisfaction, the interventions' maximum probabilities of cost-effective were low (≤0.55). All interventions had a negative return-on-investment. The combined intervention may be cost-effective for NFR depending on the decision-makers' willingness-to-pay. Both separate interventions are not cost-effective for NFR. All interventions were neither cost-effective for general vitality and job satisfaction, nor cost-saving to the employer.

Patient versus general population health state valuations: a case study of non-specific low back pain.

PURPOSE: The purpose of this study was twofold: (1) to compare non-specific low back pain (LBP) patients' health state valuations with those of the general population, and (2) to explore how aspects of health-related quality of life as measured by the EQ-5D-3L impact non-specific LBP patient valuations. METHODS: Data were used of a randomized controlled trial, including 483 non-specific LBP patients. Outcomes included the EQ-VAS and the EQ-5D-3L. Patient valuations were derived from the EQ-VAS. Population valuations were derived from the EQ-5D-3L using a Dutch VAS-based tariff. The difference between patient and population valuations was assessed using t tests. An OLS linear regression model was constructed to explore how various aspects of health-related quality of life as measured by the ED-5D-3L impact non-specific LBP patient valuations. RESULTS: Non-specific LBP patients valued their health states 0.098 (95% CI 0.082-0.115) points higher than the general population. Only 22.2% of the variance in patient valuations was explained by the patients' EQ-5D-3L health states (R 2 = 0.222). Non-specific LBP patients gave the most weight to the anxiety/depression dimension. CONCLUSIONS: This study demonstrated that non-specific LBP patients value their health states higher than members of the general population and that the choice of valuation method could have important implications for cost-effectiveness analyses and thus for clinical practice.

Rational and design of an individual participant data meta-analysis of spinal manipulative therapy for chronic low back pain-a protocol.

BACKGROUND: Chronic low back pain (LBP) is the leading cause of pain and disability, resulting in a major socioeconomic impact. The Cochrane Review which examined the effect of spinal manipulative therapy (SMT) for chronic LBP concluded that SMT is moderately effective, but was based on conventional meta-analysis of aggregate data. The use of individual participant data (IPD) from trials allows for a more precise estimate of the treatment effect and has the potential to identify moderators and/or mediators. The aim is (1) to assess the overall treatment effect of SMT for primary and secondary outcomes in adults with chronic LBP, (2) to determine possible moderation of baseline characteristics on treatment effect, (3) to identify characteristics of intervention (e.g., manipulation/mobilization) that influence the treatment effect, and (4) to identify mediators of treatment effects. METHODS: All trials included in the Cochrane Review on SMT for chronic LBP will be included which were published after the year 2000, and the search will be updated. No restrictions will be placed on the type of comparison or size of the study. Primary outcomes are pain intensity and physical functioning. A dataset will be compiled consisting of individual trials and variables included according to a predefined coding scheme. Variables to be included are descriptive of characteristics of the study, treatment, comparison, participant characteristics, and outcomes at all follow-up periods. A one-stage approach with a mixed model technique based on the intention-to-treat principle will be used for the analysis. Subsequent analyses will focus on treatment effect moderators and mediators. DISCUSSION: We will analyze IPD for LBP trials in which SMT is one of the interventions. IPD meta-analysis has been shown to be more reliable and valid than aggregate data meta-analysis, although this difference might also be attributed to the number of studies that can be used or the amount of data that can be utilized. Therefore, this project may identify important gaps in our knowledge with respect to prognostic factors of treatment effects. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015025714.

Systematic review of patient history and physical examination to diagnose chronic low back pain originating from the facet joints.

Patient history and physical examination are frequently used procedures to diagnose chronic low back pain (CLBP) originating from the facet joints, although the diagnostic accuracy is controversial. The aim of this systematic review is to determine the diagnostic accuracy of patient history and/or physical examination to identify CLBP originating from the facet joints using diagnostic blocks as reference standard. We searched MEDLINE, EMBASE, CINAHL, Web of Science and the Cochrane Collaboration database from inception until June 2016. Two review authors independently selected studies for inclusion, extracted data and assessed the risk of bias. We calculated sensitivity and specificity values, with 95% confidence intervals (95% CI). Twelve studies were included, in which 129 combinations of index tests and reference standards were presented. Most of these index tests have only been evaluated in single studies with a high risk of bias. Four studies evaluated the diagnostic accuracy of the Revel's criteria combination. Because of the clinical heterogeneity, results were not pooled. The published sensitivities ranged from 0.11 (95% CI 0.02-0.29) to 1.00 (95% CI 0.75-1.00), and the specificities ranged from 0.66 (95% CI 0.46-0.82) to 0.91 (95% CI 0.83-0.96). Due to clinical heterogeneity, the evidence for the diagnostic accuracy of patient history and/or physical examination to identify facet joint pain is inconclusive. Patient history and physical examination cannot be used to limit the need of a diagnostic block. The validity of the diagnostic facet joint block should be studied, and high quality studies are required to confirm the results of single studies. SIGNIFICANCE: Patient history and physical examination cannot be used to limit the need of a diagnostic block. The validity of the diagnostic facet joint block should be studied, and high quality studies are required to confirm the results of single studies.

Cost-effectiveness of manual therapy versus physiotherapy in patients with sub-acute and chronic neck pain: a randomised controlled trial.

PURPOSE: To evaluate the cost-effectiveness of manual therapy according to the Utrecht School (MTU) in comparison with physiotherapy (PT) in sub-acute and chronic non-specific neck pain patients from a societal perspective. METHODS: An economic evaluation was conducted alongside a 52-week randomized controlled trial, in which 90 patients were randomized to the MTU group and 91 to the PT group. Clinical outcomes included perceived recovery (yes/no), functional status (continuous and yes/no), and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective using self-reported questionnaires. Missing data were imputed using multiple imputation. To estimate statistical uncertainty, bootstrapping techniques were used. RESULTS: After 52 weeks, there were no significant between-group differences in clinical outcomes. During follow-up, intervention costs (ß:€-32; 95 %CI: -54 to -10) and healthcare costs (ß:€-126; 95 %CI: -235 to -32) were significantly lower in the MTU group than in the PT group, whereas unpaid productivity costs were significantly higher (ß:€186; 95 %CI:19-557). Societal costs did not significantly differ between groups (ß:€-96; 95 %CI:-1975-2022). For QALYs and functional status (yes/no), the maximum probability of MTU being cost-effective in comparison with PT was low (≤0.54). For perceived recovery (yes/no) and functional status (continuous), a large amount of money must be paid per additional unit of effect to reach a reasonable probability of cost-effectiveness. CONCLUSIONS: From a societal perspective, MTU was not cost-effective in comparison with PT in patients with sub-acute and chronic non-specific neck pain for perceived recovery, functional status, and QALYs. As no clear total societal cost and effect differences were found between MTU and PT, the decision about what intervention to administer, reimburse, and/or implement can be based on the preferences of the patient and the decision-maker at hand. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00713843.

Somatization is associated with worse outcome in a chiropractic patient population with neck pain and low back pain.

AIM: To determine if psychosocial factors are associated with outcome in patients with neck pain or low back pain. METHODS: In a prospective, multi-center chiropractic practice-based cohort study in Belgium and The Netherlands, 917 patients, of which 326 with neck pain and 591 with low back pain, completed self-administered questionnaires at baseline, following the second visit, and at 1, 3, 6 and 12 months. Psychosocial factors assessed at baseline were: distress, depression, anxiety and somatization via the Four Dimensional Symptom Questionnaire, patient's beliefs regarding the effect of physical activity and work on their complaint via the Fear Avoidance Beliefs Questionnaire, and social support via the Feij social support scale. Primary outcome measures were perceived recovery, pain intensity, and functional status which was measured with the Neck Disability Index and Oswestry Disability Index. A univariable regression analysis to estimate the relation between each psychological variable and outcome was followed by a multivariable multilevel regression analysis. RESULTS: There were no differences in baseline patient characteristics between the patient population from Belgium and the Netherlands. Somatization scores are consistently associated with perceived recovery, functional status and pain for both neck pain and low-back pain. Depression was associated with poorer functioning in patients with LBP. There was a small association between fear and function and pain for patients with neck pain or low-back pain. CONCLUSION: Somatization was the only variable consistently found to be associated with diminished perceived recovery, higher degree of neck or low back disability, and increased neck or low back pain.

Health economic evidence gaps and methodological constraints in low back pain and neck pain: Results of the Research Agenda for Health Economic Evaluation (RAHEE) project.

Despite the increased interest in economic evaluations, there are difficulties in applying the results of such studies in practice. Therefore, the "Research Agenda for Health Economic Evaluation" (RAHEE) project was initiated, which aimed to improve the use of health economic evidence in practice for the 10 highest burden conditions in the European Union (including low back pain [LBP] and neck pain [NP]). This was done by undertaking literature mapping and convening an Expert Panel meeting, during which the literature mapping results were discussed and evidence gaps and methodological constraints were identified. The current paper is a part of the RAHEE project and aimed to identify economic evidence gaps and methodological constraints in the LBP and NP literature, in particular. The literature mapping revealed that economic evidence was unavailable for various commonly used LBP and NP treatments (e.g., injections, traction, and discography). Even if economic evidence was available, many treatments were only evaluated in a single study or studies for the same intervention were highly heterogeneous in terms of their patient population, control condition, follow-up duration, setting, and/or economic perspective. Up until now, this has prevented economic evaluation results from being statistically pooled in the LBP and NP literature, and strong conclusions about the cost-effectiveness of LBP and NP treatments can therefore not be made. The Expert Panel identified the need for further high-quality economic evaluations, especially on surgery versus conservative care and competing treatment options for chronic LBP. Handling of uncertainty and reporting quality were considered the most important methodological challenges.

Multidisciplinary biopsychosocial rehabilitation for chronic low back pain: Cochrane systematic review and meta-analysis.

OBJECTIVE: To assess the long term effects of multidisciplinary biopsychosocial rehabilitation for patients with chronic low back pain. DESIGN: Systematic review and random effects meta-analysis of randomised controlled trials. DATA SOURCES: Electronic searches of Cochrane Back Review Group Trials Register, CENTRAL, Medline, Embase, PsycINFO, and CINAHL databases up to February 2014, supplemented by hand searching of reference lists and forward citation tracking of included trials. STUDY SELECTION CRITERIA: Trials published in full; participants with low back pain for more than three months; multidisciplinary rehabilitation involved a physical component and one or both of a psychological component or a social or work targeted component; multidisciplinary rehabilitation was delivered by healthcare professionals from at least two different professional backgrounds; multidisciplinary rehabilitation was compared with a non- multidisciplinary intervention. RESULTS: Forty one trials included a total of 6858 participants with a mean duration of pain of more than one year who often had failed previous treatment. Sixteen trials provided moderate quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.21, 95% confidence interval 0.04 to 0.37; equivalent to 0.5 points in a 10 point pain scale) and disability (0.23, 0.06 to 0.40; equivalent to 1.5 points in a 24 point Roland-Morris index) compared with usual care. Nineteen trials provided low quality evidence that multidisciplinary rehabilitation decreased pain (standardised mean difference 0.51, -0.01 to 1.04) and disability (0.68, 0.16 to 1.19) compared with physical treatments, but significant statistical heterogeneity across trials was present. Eight trials provided moderate quality evidence that multidisciplinary rehabilitation improves the odds of being at work one year after intervention (odds ratio 1.87, 95% confidence interval 1.39 to 2.53) compared with physical treatments. Seven trials provided moderate quality evidence that multidisciplinary rehabilitation does not improve the odds of being at work (odds ratio 1.04, 0.73 to 1.47) compared with usual care. Two trials that compared multidisciplinary rehabilitation with surgery found little difference in outcomes and an increased risk of adverse events with surgery. CONCLUSIONS: Multidisciplinary biopsychosocial rehabilitation interventions were more effective than usual care (moderate quality evidence) and physical treatments (low quality evidence) in decreasing pain and disability in people with chronic low back pain. For work outcomes, multidisciplinary rehabilitation seems to be more effective than physical treatment but not more effective than usual care.

Reliability, responsiveness and interpretability of the neck disability index-Dutch version in primary care.

PURPOSE: To establish an evidence-based recommendation for the pragmatic use of the Neck Disability Index-Dutch Version (NDI-DV) in primary care based on an assessment of the reliability, the responsiveness, and the interpretability of the NDI-DV. STUDY DESIGN AND SETTING/METHODS: At baseline, the NDI-DV was completed by 337 patients with neck pain presenting to 97 chiropractic clinics in Belgium and the Netherlands. Three months after inclusion, 265 patients provided data to assess the responsiveness and interpretability. Reliability was assessed in 155 patients (retested after 10 days) by calculating the intra-class correlation coefficient for agreement (ICCagreement) and the measurement error (standard error of measurement, SEM), the latter resulting in the smallest detectable change (SDC). The minimal important change (MIC) was assessed by the anchor-based MIC distribution using self-reported perceived recovery as anchor. We tested interpretability by relating SDC to MIC. RESULTS: The ICCagreement was 0.88. The SEMagreement was 1.95 resulting in a SDC of 5.40. The NDI-DV appeared to be responsive, being able to distinguish improved from stable patients with an area under the curve of 0.85. The MIC was 4.50. CONCLUSION: The NDI-DV has good reliability and responsiveness and may be used in clinical practice in Belgium and the Netherlands. A change score of 5 is important for patients, but has a 7 % chance to be due to measurement error.

Characteristics of older patients with back pain in general practice: BACE cohort study.

BACKGROUND: Although back pain is common among older people, limited information is available about the characteristics of these patients in primary care. Earlier research suggests that the severity of back symptoms increases with older age. METHODS: Patients aged >55 years visiting a general practitioner with a new episode of back pain were included in the BACE study. Information on patients' characteristics, characteristics of the complaint and physical examination were derived from the baseline measurement. Cross-sectional differences between patients aged >55-74 and ≥75 years were analysed using an unpaired t-test, Mann-Whitney U-test or a chi-square test. RESULTS: A total of 675 back pain patients were included in the BACE study, with a median age of 65 (interquartile range 60-71) years. Patients aged >55-74 years had a mean disability score (measured with the Roland Disability Questionnaire) of 9.4 [standard deviation (SD) 5.8] compared with 12.1 (SD 5.5) in patients aged ≥75 years (p ≤ 0.01). The older group reported more additional musculoskeletal disorders and more often had low bone quality (based on ultrasound measurement of the heel) than patients aged >55-74 years. Average back pain severity over the previous week showed no difference (p = 0.11) between the age groups, but severity of back pain at the moment of filling in the questionnaire was higher (p = 0.03) in the older age group. CONCLUSIONS: In this study, older back pain patients reported more disabilities and co-morbidity. However, the clinical relevance of these differences for the course of the back pain episode in older patients remains a subject for further research.