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 .

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.

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 ).

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.

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 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.

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.

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.

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.

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.

Multifactorial evaluation and treatment of persons with a high risk of recurrent falling was not cost-effective.

SUMMARY: This study evaluated the cost-effectiveness of multifactorial evaluation and treatment of fall risk factors in community-dwelling older persons at high risk of falling. The intervention and usual care groups did not differ in fall risk or costs. The multifactorial approach was not cost-effective compared to usual care in this group. INTRODUCTION: International guidelines recommend multifactorial evaluation and tailored treatment of risk factors to reduce falling in older persons. The cost-effectiveness may be enhanced in high-risk persons. Our study evaluates the cost-effectiveness of multifactorial evaluation and treatment of fall risk factors in community-dwelling older persons at high risk of recurrent falling. METHODS: An economic evaluation was conducted alongside a randomised controlled trial. Participants (≥65 years) with a high risk of recurrent falling were randomised into an intervention (n = 106) and usual care group (n = 111). The intervention consisted of multifactorial assessment and treatment of fall risk factors. Clinical outcomes were proportions of fallers and utility during 1 year. Costs were measured using questionnaires at 3, 6 and 12 months after baseline and valued using cost prices, if available, and guideline prices. Differences in costs and cost-effectiveness were analysed using bootstrapping. Cost-effectiveness planes and acceptability curves were presented. RESULTS: During 1 year, 52% and 56% of intervention and usual care participants reported at least one fall, respectively. The clinical outcome measures did not differ between the two groups. The mean costs were Euro 7,740 (SD 9,129) in the intervention group and Euro 6,838 (SD 8,623) in the usual care group (mean difference Euro 902, bootstrapped 95% CI: -1,534 to 3,357). Cost-effectiveness planes and acceptability curves indicated that multifactorial evaluation and treatment of fall risk factors was not cost-effective compared with usual care. CONCLUSIONS: Multifactorial evaluation and treatment of persons with a high risk of recurrent falling was not cost-effective compared to usual care.

Inflammatory bowel disease: a systematic review on the value of diagnostic testing in primary care.

AIM: The clinical presentation of inflammatory bowel disease in primary care represents a diagnostic challenge as its symptoms are heterogeneous and common. To assist the primary care physician, we have summarized the available evidence on diagnostic tests in patients with abdominal symptoms. METHOD: We searched PubMed and Embase and screened references. Studies were selected if the design was a primary diagnostic study. Patients were adults attending with nonacute abdominal symptoms. Tests included clinical assessment, blood or faecal tests or abdominal ultrasonography. Quality assessment using a modified version of the QUADAS tool and data extraction was performed by two reviewers independently. Diagnostic two-by-two tables and pooled estimates of sensitivity and specificity are given. We refrained from pooling when there was considerable clinical or statistical heterogeneity. RESULTS: A total of 24 studies were included. While the diagnostic performance of the individual symptoms was highly variable (range sensitivity 0.0-0.96, specificity 0.09-1.0), the performance of symptom-based classification systems was both more consistent and better (sensitivity 0.65-1.0, specificity 0.17-0.82). Among faecal and blood tests, calprotectin was studied most frequently and showed the best results (sensitivity 0.61-1.0, specificity 0.71-1.0). Statistical pooling for ultrasonography resulted in a sensitivity of 0.73 (0.65-0.80) and a specificity of 0.95 (0.91-0.97). CONCLUSION: Although calprotectin and ultrasonography showed consistent and promising findings, none of the studies was performed in primary care. To assist primary care physicians in diagnostic decision making, we urgently need high quality studies performed in primary care.

A systematic review on the effectiveness of pharmacological interventions for chronic non-specific low-back pain.

The objective of this review was to determine the effectiveness of pharmacological interventions [i.e., non-steroid anti-inflammatory drugs (NSAIDs), muscle relaxants, antidepressants, and opioids] for non-specific chronic low-back pain (LBP). Existing Cochrane reviews for the four interventions were screened for studies fulfilling the inclusion criteria. Then, the literature searches were updated. Only randomized controlled trials on adults (≥18 years) with chronic (≥12 weeks) non-specific LBP and evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work) were included. The GRADE approach was used to determine the quality of evidence. A total of 17 randomized controlled trials was included: NSAIDs (n = 4), antidepressants (n = 5), and opioids (n = 8). No studies were found for muscle relaxants; 14 studies had a low risk of bias. The studies only reported effects on the short term (<3 months). The overall quality of the evidence was low. NSAIDs and opioids seem to lead to a somewhat higher relief in pain on the short term, as compared to placebo, in patients with non-specific chronic low back pain; opioids seem to have a small effect in improving function for a selection of patients who responded with an exacerbation of their symptoms after stopping their medication. However, both types of medication show more adverse effects than placebo. There seems to be no difference in effect between antidepressants and placebo in patients with non-specific chronic LBP.

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.

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.

Lumbar supports for prevention and treatment of low back pain.

BACKGROUND: Lumbar supports are used in the treatment of low-back pain patients, to prevent the onset of low-back pain (primary prevention) or to prevent recurrences of a low-back pain episode (secondary prevention). OBJECTIVES: To assess the effects of lumbar supports for prevention and treatment of non-specific low-back pain. SEARCH STRATEGY: We updated the search in the Cochrane Central Register of Controlled Trials, PubMed, EMBASE, and CINAHL to December 2006. We also screened references given in relevant reviews and identified trials, and contacted experts to identify additional RCTs. SELECTION CRITERIA: Randomized controlled trials that reported on any type of lumbar supports as preventive or therapeutic intervention for non-specific low-back pain. DATA COLLECTION AND ANALYSIS: One review author generated the electronic search. Two review authors independently identified trials that met the inclusion criteria. One review author extracted data on the study population, interventions, and final results. The methodological quality and the clinical relevance were independently assessed by two review authors. Because it was not possible to perform a quantitative analysis, we performed a qualitative analysis in which the strength of evidence on the effectiveness of lumbar supports was classified as strong, moderate, limited, conflicting, or no evidence. MAIN RESULTS: Seven preventive studies (14,437 people) and eight treatment studies (1361 people) were included in this updated review. Overall, the methodological quality of the studies was rather low. Only five of the fifteen studies met 50% or more of the internal validity items. There was moderate evidence that lumbar supports are not more effective than no intervention or training in preventing low-back pain, and conflicting evidence whether lumbar supports are effective supplements to other preventive interventions. It is still unclear if lumbar supports are more effective than no or other interventions for the treatment of low-back pain. AUTHORS' CONCLUSIONS: There is moderate evidence that lumbar supports are not more effective than no intervention or training in preventing low-back pain, and conflicting evidence whether they are effective supplements to other preventive interventions. It remains unclear whether lumbar supports are more effective than no or other interventions for treating low-back pain. There is still a need for high quality randomized trials on the effectiveness of lumbar supports. One of the most essential issues to tackle in these future trials seems to be the realization of an adequate compliance. Special attention should be paid to different outcome measures, types of patients and types of lumbar support.

Antidepressants for non-specific low back pain.

BACKGROUND: Antidepressants are commonly used in the management of low-back pain. However, their use is controversial. OBJECTIVES: The aim of this review was to determine whether antidepressants are more effective than placebo for the treatment of non-specific low-back pain. SEARCH STRATEGY: Randomised controlled trials were identified from MEDLINE and EMBASE (to September 2007), PsycINFO to June 2006, the Cochrane Central Register of Controlled Trials 2006, issue 2, and previous systematic reviews. SELECTION CRITERIA: We included randomised controlled trials that compared antidepressant medication and placebo for patients with non-specific low-back pain, and used at least one clinically relevant outcome measure. DATA COLLECTION AND ANALYSIS: Two blinded review authors independently extracted data and assessed the methodological quality of the trials. Meta-analyses were used to examine the effect of antidepressants on pain, depression and function, and the effect of antidepressant type on pain. To account for studies that could not be pooled, additional qualitative analyses were performed using the levels of evidence recommended by the Cochrane Back Review Group. MAIN RESULTS: Ten trials that compared antidepressants with placebo were included in this review. The pooled analyses showed no difference in pain relief (six trials; standardized mean difference (SMD) -0.06 (95% confidence interval (CI) -0.28 to 0.16)) or depression (two trials; SMD 0.06 (95% CI -0.29 to 0.40)) between antidepressant and placebo treatments. The qualitative analyses found conflicting evidence on the effect of antidepressants on pain intensity in chronic low-back pain, and no clear evidence that antidepressants reduce depression in chronic low-back pain patients. Two pooled analyses showed no difference in pain relief between different types of antidepressants and placebo. Our findings were not altered by the sensitivity analyses which varied the level of methodological quality required for inclusion in the meta-analyses to allow data from additional trials to be examined. Two additional trials were identified in September 2007 and await assessment. AUTHORS' CONCLUSIONS: There is no clear evidence that antidepressants are more effective than placebo in the management of patients with chronic low-back pain. These findings do not imply that severely depressed patients with back pain should not be treated with antidepressants; furthermore, there is evidence for their use in other forms of chronic pain.

Individual patient education for low back pain.

BACKGROUND: While many different types of patient education are widely used, the effect of individual patient education for low-back pain (LBP) has not yet been systematically reviewed. OBJECTIVES: To determine whether individual patient education is effective in the treatment of non-specific low-back pain and which type is most effective. SEARCH STRATEGY: A computerized literature search of MEDLINE (1966 to July 2006), EMBASE (1988 to July 2006), CINAHL (1982 to July 2006), PsycINFO (1984 to July 2006), and the Cochrane Central Register of Controlled Trials (The Cochrane Library 2006, Issue 2) was performed. References cited in the identified articles were screened. SELECTION CRITERIA: Studies were selected if the design was a randomised controlled trial; if patients experienced LBP; if the type of intervention concerned individual patient education, and if the publication was written in English, German, or Dutch. DATA COLLECTION AND ANALYSIS: The methodological quality was independently assessed by two review authors. Articles that met at least 50% of the quality criteria were considered high quality. Main outcome measures were pain intensity, global measure of improvement, back pain-specific functional status, return-to-work, and generic functional status. Analysis comprised a qualitative analysis. Evidence was classified as strong, moderate, limited, conflicting or no evidence. MAIN RESULTS: Of the 24 studies included in this review, 14 (58%) were of high quality. Individual patient education was compared with no intervention in 12 studies; with non-educational interventions in 11 studies; and with other individual educational interventions in eight studies. Results showed that for patients with subacute LBP, there is strong evidence that an individual 2.5 hour oral educational session is more effective on short-term and long-term return-to-work than no intervention. Educational interventions that were less intensive were not more effective than no intervention. Furthermore, there is strong evidence that individual education for patients with (sub)acute LBP is as effective as non-educational interventions on long-term pain and global improvement and that for chronic patients, individual education is less effective for back pain-specific function when compared to more intensive interventions. Comparison of different types of individual education did not show significant differences. AUTHORS' CONCLUSIONS: For patients with acute or subacute LBP, intensive patient education seems to be effective. For patients with chronic LBP, the effectiveness of individual education is still unclear.

Non-steroidal anti-inflammatory drugs for low back pain.

BACKGROUND: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are widely used for patients with low-back pain. Selective COX-2 inhibitors are currently available and used for patients with low-back pain. OBJECTIVES: The objective was to assess the effects of NSAIDs and COX-2 inhibitors in the treatment of non-specific low-back pain and to assess which type of NSAID is most effective. SEARCH STRATEGY: We searched the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Trials up to and including June 2007 if reported in English, Dutch or German. We also screened references given in relevant reviews and identified trials. SELECTION CRITERIA: Randomised trials and double-blind controlled trials of NSAIDs in non-specific low-back pain with or without sciatica were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed methodological quality. All studies were also assessed on clinical relevance, from which no further interpretations or conclusions were drawn. If data were considered clinically homogeneous, a meta-analysis was performed. If data were lacking for clinically homogeneous trials, a qualitative analysis was performed using a rating system with four levels of evidence (strong, moderate, limited, no evidence). MAIN RESULTS: In total, 65 trials (total number of patients = 11,237) were included in this review. Twenty-eight trials (42%) were considered high quality. Statistically significant effects were found in favour of NSAIDs compared to placebo, but at the cost of statistically significant more side effects. There is moderate evidence that NSAIDs are not more effective than paracetamol for acute low-back pain, but paracetamol had fewer side effects. There is moderate evidence that NSAIDs are not more effective than other drugs for acute low-back pain. There is strong evidence that various types of NSAIDs, including COX-2 NSAIDs, are equally effective for acute low-back pain. COX-2 NSAIDs had statistically significantly fewer side-effects than traditional NSAIDs. AUTHORS' CONCLUSIONS: The evidence from the 65 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute and chronic low-back pain without sciatica. However, effect sizes are small. Furthermore, there does not seem to be a specific type of NSAID which is clearly more effective than others. The selective COX-2 inhibitors showed fewer side effects compared to traditional NSAIDs in the RCTs included in this review. However, recent studies have shown that COX-2 inhibitors are associated with increased cardiovascular risks in specific patient populations.