Previous reviews of randomised controlled trials (RCTs) for low-back pain (LBP) have failed to identify any positive trend in study quality with more recent years of publication. This study aimed to identify and describe trends over time in the study design characteristics and risk of bias in chronic LBP trials performed over the past 30 years.
One fifty-seven randomised trials of interventions for chronic LBP were extracted from recently published systematic reviews. The reviews included RCTs on physical and rehabilitation interventions, injection therapy and denervation procedures, complementary and alternative therapies and pharmacological interventions for chronic LBP. Study level data were extracted and analysed for trends associated with year of publication.
Overall, the mean sample size in the RCTs was 141 (median 70; range 17–3093). There was a slight increase in the median number of risk of bias criteria fulfilled from trials published prior to 1995 to those published after 1996. The analysis showed that in more recent years RCTs of medical interventions were more likely to be successfully blinded than RCTs of non-medical interventions.
The continuing uncertainty regarding the efficacy of many interventions for chronic LBP again stresses the need for large RCTs with low risk of bias. Further research is needed into specific risks of bias within the RCTs for chronic LBP and the effect they have on the plausibility of the results.
Back pain; Bias; Methodology; Randomised trials
In about 5% of all cases LBP is associated with serious underlying pathology requiring diagnostic confirmation and directed treatment. Magnetic resonance imaging (MRI) is often used for this diagnostic purpose yet its role remains controversial. Consequently, this review aimed to summarize the available evidence on the diagnostic accuracy of MRI for identifying lumbar spinal pathology in adult low back pain (LPB) or sciatica patients.
MEDLINE, EMBASE and CINAHL were searched (until December 2009) for observational studies assessing the diagnostic accuracy of MRI compared to a reference test for the identification of lumbar spinal pathology. Two reviewers independently selected studies for inclusion, extracted data and assessed methodological quality. Pooled summary estimates of sensitivity and specificity with 95% confidence intervals were calculated for homogenous subsets of studies.
Eight studies were included in this review. Strata were defined for separate pathologies i.e. lumbar disc herniation (HNP) and spinal stenosis. Five studies comparing MRI to findings at the surgery for identifying HNP were included in a meta-analysis. Pooled analysis resulted in a summary estimate of sensitivity of 75% (95% CI 65–83%) and specificity of 77% (95% CI 61–88%). For spinal stenosis pooling was not possible.
The results suggest that a considerable proportion of patients may be classified incorrectly by MRI for HNP and spinal stenosis. However, the evidence for the diagnostic accuracy of MRI found by this review is not conclusive, since the results could be distorted due to the limited number of studies and large heterogeneity.
Diagnostic accuracy; Systematic review; MRI; Low back pain; Diagnostic imaging
Mental health problems are common and are associated with increased disability and health care costs. Problem-Solving Treatment (PST) delivered to these patients by nurses in primary care might be efficient. The aim of this study was to evaluate the cost-effectiveness of PST by mental health nurses compared with usual care (UC) by the general practitioner for primary care patients with mental health problems.
An economic evaluation from a societal perspective was performed alongside a randomized clinical trial. Patients with a positive General Health Questionnaire score (score ≥ 4) and who visited their general practitioner at least three times during the past 6 months were eligible. Outcome measures were improvement on the Hospital Anxiety and Depression Scale and QALYs based on the EQ-5D. Resource use was measured using a validated questionnaire. Missing cost and effect data were imputed using multiple imputation techniques. Bootstrapping was used to analyze costs and cost-effectiveness of PST compared with UC.
There were no statistically significant differences in clinical outcomes at 9 months. Mean total costs were €4795 in the PST group and €6857 in the UC group. Costs were not statistically significantly different between the two groups (95% CI -4698;359). The cost-effectiveness analysis showed that PST was cost-effective in comparison with UC. Sensitivity analyses confirmed these findings.
PST delivered by nurses seems cost-effective in comparison with UC. However, these results should be interpreted with caution, since the difference in total costs was mainly caused by 3 outliers with extremely high indirect costs in the UC group.
Nederlands Trial Register ISRCTN51021015
Costs and cost analysis; Problem-solving treatment; Nurses; Depression; Anxiety; Primary health care
The additional benefit of lifestyle interventions in patients receiving cardioprotective drug treatment to improve cardiovascular risk profile is not fully established.
The objective was to evaluate the effectiveness of a target-driven multidisciplinary structured lifestyle intervention programme of 6 months duration aimed at maximum reduction of cardiovascular risk factors in patients with cardiovascular disease (CVD) compared with usual care.
A single centre, two arm, parallel group randomised controlled trial was performed. Patients with stable established CVD and at least one lifestyle-related risk factor were recruited from the vascular and cardiology outpatient departments of the university hospital. Blocked randomisation was used to allocate patients to the intervention (n = 71) or control group (n = 75) using an on-site computer system combined with allocations in computer-generated tables of random numbers kept in a locked computer file. The intervention group received the comprehensive lifestyle intervention offered in a specialised outpatient clinic in addition to usual care. The control group continued to receive usual care. Outcome measures were the lifestyle-related cardiovascular risk factors: smoking, physical activity, physical fitness, diet, blood pressure, plasma total/HDL/LDL cholesterol concentrations, BMI, waist circumference, and changes in medication.
The intervention led to increased physical activity/fitness levels and an improved cardiovascular risk factor profile (reduced BMI and waist circumference). In this setting, cardiovascular risk management for blood pressure and lipid levels by prophylactic treatment for CVD in usual care was already close to optimal as reflected in baseline levels. There was no significant improvement in any other risk factor.
Even in CVD patients receiving good clinical care and using cardioprotective drug treatment, a comprehensive lifestyle intervention had a beneficial effect on some cardiovascular risk factors. In the present era of cardiovascular therapy and with the increasing numbers of overweight and physically inactive patients, this study confirms the importance of risk factor control through lifestyle modification as a supplement to more intensified drug treatment in patients with CVD.
ISRCTN69776211 at http://www.controlled-trials.com
Cardiovascular diseases; Lifestyle intervention; Smoking; Physical activity; Diet; Health behaviour; Randomised controlled trial; Cardiology; Therapy; Cardiovascular risk management
Disc herniation with sciatica accounts for five percent of low-back disorders but is one of the most common reasons for spine surgery. The goal of this study was to update the Cochrane review on the effect of surgical techniques for sciatica due to disc herniation, which was last updated in 2007.
Materials and methods
In April 2011, we conducted a comprehensive search in CENTRAL, MEDLINE, EMBASE, CINAHL, PEDRO, ICL, and trial registries. We also checked the reference lists and citation tracking results of each retrieved article. Only randomized controlled trials (RCT) of the surgical management of sciatica due to disc herniation were included. Comparisons including chemonucleolysis and prevention of scar tissue or comparisons against conservative treatment were excluded. Two review authors independently selected studies, assessed risk of bias of the studies and extracted data. Quality of evidence was graded according to the GRADE approach.
Seven studies from the original Cochrane review were included and nine additional studies were found. In total, 16 studies were included, of which four had a low risk of bias. Studies showed that microscopic discectomy results in a significantly, but not clinically relevant longer operation time of 12 min (95 % CI 2–22) and shorter incision of 24 mm (95 % CI 7–40) compared with open discectomy, but did not find any clinically relevant superiority of either technique on clinical results. There were conflicting results regarding the comparison of tubular discectomy versus microscopic discectomy for back pain and surgical duration.
Due to the limited amount and quality of evidence, no firm conclusions on effectiveness of the current surgical techniques being open discectomy, microscopic discectomy, and tubular discectomy compared with each other can be drawn. Those differences in leg or back pain scores, operation time, and incision length that were found are clinically insignificant. Large, high-quality studies are needed, which examine not only effectiveness but cost-effectiveness as well.
Herniated disc; Sciatica; Surgery; Discectomy; Systematic review
Diabetes during pregnancy can lead to severe risks for both mother and fetus when it is not managed properly. The use of rigorously developed guidelines with a robust implementation process can have a positive influence on the management of diabetes during pregnancy. This study aims to compare recommendations and assess the quality of clinical guidelines on gestational diabetes mellitus (GDM) and pre-existing diabetes mellitus during pregnancy.
Guidelines were selected by searching PubMed, the Guideline Clearing House and Google. All guidelines developed since 2000 on diabetes during pregnancy in English or Dutch were considered. Recommendations of the guidelines were compared. Furthermore, the quality was assessed by two authors independently, using the AGREE instrument.
Eight guidelines were included. According to the AGREE instrument, the quality of most guidelines was low. The domains editorial independence, stakeholder involvement and rigour of development had the lowest scores. Recommendations were mainly comparable on glycemic control, preconceptional counseling and prenatal care and labour. Differences between recommendations were found for screening on GDM and induction of labour.
The quality of most guidelines concerning the management of diabetes during pregnancy needs to be improved. A more systematic approach in the development of these guidelines, more attention for updating procedures and piloting of the guidelines and involvement of target users and patients is recommended.
Clinical guidelines; Diabetes mellitus; Gestational diabetes; Pregnancy
Various conservative interventions have been used for the treatment of non-specific neck pain. The aim of this systematic review was to investigate the cost-effectiveness of conservative treatments for non-specific neck pain.
Clinical and economic electronic databases, reference lists and authors’ databases were searched up to 13 January 2011. Two reviewers independently selected studies for inclusion, performed the risk of bias assessment and data extraction.
A total of five economic evaluations met the inclusion criteria. All studies were conducted alongside randomised controlled trials and included a cost-utility analysis, and four studies also conducted a cost-effectiveness analysis. Most often, the economic evaluation was conducted from a societal or a health-care perspective. One study found that manual therapy was dominant over physiotherapy and general practitioner care, whilst behavioural graded activity was not cost-effective compared to manual therapy. The combination of advice and exercise with manual therapy was not cost-effective compared to advice and exercise only. One study found that acupuncture was cost-effective compared to a delayed acupuncture intervention, and another study found no differences on cost-effectiveness between a brief physiotherapy intervention compared to usual physiotherapy. Pooling of the data was not possible as heterogeneity existed between the studies on participants, interventions, controls, outcomes, follow-up duration and context related socio-political differences.
At present, the limited number of studies and the heterogeneity between studies warrant no definite conclusions on the cost-effectiveness of conservative treatments for non-specific neck pain.
Systematic review; Cost-effectiveness; Neck pain; Conservative treatment; Economic evaluation
Identifying relevant subgroups in patients with low back pain (LBP) is considered important to guide physical therapy practice and to improve outcomes. The aim of the present study was to assess the cost-effectiveness of a modified version of Delitto’s classification-based treatment approach compared with usual physical therapy care in patients with sub-acute and chronic LBP with 1 year follow-up.
All patients were classified using the modified version of Delitto’s classification-based system and then randomly assigned to receive either classification-based treatment or usual physical therapy care. The main clinical outcomes measured were; global perceived effect, intensity of pain, functional disability and quality of life. Costs were measured from a societal perspective. Multiple imputations were used for missing data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated.
In total, 156 patients were included. The outcome analyses showed a significantly better outcome on global perceived effect favoring the classification-based approach, and no differences between the groups on pain, disability and quality-adjusted life-years. Mean total societal costs for the classification-based group were €2,287, and for the usual physical therapy care group €2,020. The difference was €266 (95% CI €-720 to €1,612) and not statistically significant. Cost-effectiveness analyses showed that the classification-based approach was not cost-effective in comparison with usual physical therapy care for any clinical outcome measure.
The classification-based treatment approach as used in this study was not cost-effective in comparison with usual physical therapy care in a population of patients with sub-acute and chronic LBP.
Low back pain; Economic evaluation; Cost-effectiveness analysis; RCT; Classification
In low back pain if serious pathology is suspected diagnostic imaging could be performed. One of the imaging techniques available for this purpose is computed tomography (CT), however, insight in the diagnostic performance of CT is unclear.
Diagnostic systematic review. Studies assessing the diagnostic accuracy of CT in adult patients suggested having low back pain caused by specific pathology were selected. Two review authors independently selected studies for inclusion, extracted data and assessed risk of bias. Pooled summary estimates of sensitivity and specificity with 95% CI were calculated.
Seven studies were included, all describing the diagnostic accuracy of CT in identifying lumbar disc herniation. Six studies used surgical findings as the reference standard and were considered sufficiently homogenous to carry out a meta-analysis. The pooled summary estimate of sensitivity was 77.4% and specificity was 73.7%.
We found no studies evaluating the accuracy of CT for pathologies such as vertebral cancer, infection and fractures and this remains unclear. Our results should be interpreted with some caution. Sensitivity and specificity, regarding the detection of lumbar disc herniation, showed that a substantial part of the patients is still classified as false-negative and false-positive. In future, the diagnostic performance of CT must be assessed in high quality prospective cohort studies with an unselected population of patients with low back pain.
Computed tomography; Low back pain; Diagnostic imaging; Systematic review
Although back complaints are common among older people, limited information is available in the literature about the clinical course of back pain in older people and the identification of older persons at risk for the transition from acute back complaints to chronic back pain.
The aim of this study is to assess the course of back complaints and identify prognostic factors for the transition from acute back complaints to chronic back complaints in older people who visit a primary health care physician.
The design is a prospective cohort study with one-year follow-up. There will be no interference with usual care. Patients older than 55 years who consult a primary health care physician with a new episode of back complaints will be included in this study.
Data will be collected using a questionnaire, physical examination and X-ray at baseline, and follow-up questionnaires after 6 weeks and 3, 6, 9 and 12 months.
The study 'Back Complaints in the Elders' (BACE) will take place in different countries: starting in the Netherlands, Brazil and Australia. The research groups collaborate in the BACE consortium. The design and basic objectives of the study will be the same across the studies.
This consortium is a collaboration between different research groups, aiming to provide insight into the course of back complaints in older people and to identify prognostic factors for the transition from acute back complaints to chronic back complaints in older persons. The BACE consortium allows to investigate differences between older people with back complaints and the health care systems in the different countries and to increase the statistical power by enabling meta-analyses using the individual patient data. Additional research groups worldwide are invited to join the BACE consortium.
Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting.
Methods and design
An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up.
This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS.
Trial registration number: NTR2575
Chronic non-specific low-back pain (LBP) is one of the most common and expensive musculoskeletal disorders in industrialized countries. Similar to other countries in the world, LBP is a common health and socioeconomic problem in Iran. One of the most widely used modalities in the field of physiotherapy for treating LBP is therapeutic ultrasound. Despite its common use, there is still inconclusive evidence to support its effectiveness in this group of patients. This randomised trial will evaluate the effectiveness of continuous ultrasound in addition to exercise therapy in patients with chronic LBP.
Methods and design
A total of 46 patients, between the ages 18 and 65 years old who have had LBP for more than three months will be recruited from university hospitals. Participants will be randomized to receive continuous ultrasound plus exercise therapy or placebo ultrasound plus exercise therapy. These groups will be treated for 10 sessions during a period of 4 weeks. Primary outcome measures will be functional disability and pain intensity. Lumbar flexion and extension range of motion, as well as changes in electromyography muscle fatigue indices, will be measured as secondary outcomes. All outcome measures will be measured at baseline, after completion of the treatment sessions, and after one month.
The results of this trial will help to provide some evidence regarding the use of continuous ultrasound in chronic LBP patients. This should lead to a more evidence-based approach to clinical decision making regarding the use of ultrasound for LBP.
Netherlands Trial Register (NTR): NTR2251
Behavioural problems are common in nursing home residents with dementia and they often are burdensome for both residents and nursing staff. In this study, the effectiveness and cost-effectiveness of a new care programme for managing behavioural problems will be evaluated.
The care programme is based on Dutch national guidelines. It will consist of four steps: detection, analysis, treatment and evaluation. A stepped wedge design will be used. A total of 14 dementia special care units will implement the care programme. The primary outcome is behavioural problems. Secondary outcomes will include quality of life, prescription rate of antipsychotics, use of physical restraints and workload and job satisfaction of nursing staff. The effect of the care programme will be estimated using multilevel linear regression analysis. An economic evaluation from a societal perspective will also be carried out.
The care programme is expected to be cost-effective and effective in decreasing behavioural problems, workload of nursing staff and in increasing quality of life of residents.
The Netherlands National Trial Register (NTR). Trial number: NTR 2141
Healthcare costs for low back pain (LBP) are increasing rapidly. Hence, it is important to provide treatments that are effective and cost-effective. The purpose of this systematic review was to investigate the cost-effectiveness of guideline-endorsed treatments for LBP. We searched nine clinical and economic electronic databases and the reference list of relevant systematic reviews and included studies for eligible studies. Economic evaluations conducted alongside randomised controlled trials investigating treatments for LBP endorsed by the guideline of the American College of Physicians and the American Pain Society were included. Two independent reviewers screened search results and extracted data. Data extracted included the type and perspective of the economic evaluation, the treatment comparators, and the relative cost-effectiveness of the treatment comparators. Twenty-six studies were included. Most studies found that interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation or cognitive-behavioural therapy were cost-effective in people with sub-acute or chronic LBP. Massage alone was unlikely to be cost-effective. There were inconsistent results on the cost-effectiveness of advice, insufficient evidence on spinal manipulation for people with acute LBP, and no evidence on the cost-effectiveness of medications, yoga or relaxation. This review found evidence supporting the cost-effectiveness of the guideline-endorsed treatments of interdisciplinary rehabilitation, exercise, acupuncture, spinal manipulation and cognitive-behavioural therapy for sub-acute or chronic LBP. There is little or inconsistent evidence for other treatments endorsed in the guideline.
Low back pain; Cost-effectiveness analysis; Systematic review
Care from a general practitioner (GP) is one of the most frequently utilised healthcare services for people with low back pain and only a small proportion of those with low back pain who seek care from a GP are referred to other services. The aim of this systematic review was to evaluate the evidence on cost-effectiveness of GP care in non-specific low back pain. We searched clinical and economic electronic databases, and the reference list of relevant systematic reviews and included studies to June 2010. Economic evaluations conducted alongside randomised controlled trials with at least one GP care arm were eligible for inclusion. Two reviewers independently screened search results and extracted data. Eleven studies were included; the majority of which conducted a cost-effectiveness or cost-utility analysis. Most studies investigated the cost-effectiveness of usual GP care. Adding advice, education and exercise, or exercise and behavioural counselling, to usual GP care was more cost-effective than usual GP care alone. Clinical rehabilitation and/or occupational intervention, and acupuncture were more cost-effective than usual GP care. One study investigated the cost-effectiveness of guideline-based GP care, and found that adding exercise and/or spinal manipulation was more cost-effective than guideline-based GP care alone. In conclusion, GP care alone did not appear to be the most cost-effective treatment option for low back pain. GPs can improve the cost-effectiveness of their treatment by referring their patients for additional services, such as advice and exercise, or by providing the services themselves.
Low back pain; Cost-effectiveness analysis; Primary health care; Systematic review
Objective To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain.
Design Economic evaluation alongside a randomised controlled trial with 12 months’ follow-up.
Setting Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9.
Participants 134 adults aged 18-65 sick listed because of chronic low back pain: 66 were randomised to integrated care and 68 to usual care.
Interventions Integrated care consisted of a workplace intervention based on participatory ergonomics, with involvement of a supervisor, and a graded activity programme based on cognitive behavioural principles. Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines.
Main outcome measures The primary outcome was duration until sustainable return to work. The secondary outcome was quality adjusted life years (QALYs), measured using EuroQol.
Results Total costs in the integrated care group (£13 165, SD £13 600) were significantly lower than in the usual care group (£18 475, SD £13 616). Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained. The cost-benefit analyses showed that every £1 invested in integrated care would return an estimated £26. The net societal benefit of integrated care compared with usual care was £5744.
Conclusions Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs, increase effectiveness of care, improve quality of life, and improve function on a broad scale. Integrated care therefore has large gains for patients and society as well as for employers.
Shoulder complaints are common in primary care and have unfavourable long term prognosis. Our objective was to evaluate the clinical effectiveness of manipulative therapy of the cervicothoracic spine and the adjacent ribs in addition to usual medical care (UMC) by the general practitioner in the treatment of shoulder complaints.
This economic evaluation was conducted alongside a randomized trial in primary care. Included were 150 patients with shoulder complaints and a dysfunction of the cervicothoracic spine and adjacent ribs. Patients were treated with UMC (NSAID's, corticosteroid injection or referral to physical therapy) and were allocated at random (yes/no) to manipulative therapy (manipulation and mobilization). Patient perceived recovery, severity of main complaint, shoulder pain, disability and general health were outcome measures. Data about direct and indirect costs were collected by means of a cost diary.
Manipulative therapy as add-on to UMC accelerated recovery on all outcome measures included. At 26 weeks after randomization, both groups reported similar recovery rates (41% vs. 38%), but the difference between groups in improvement of severity of the main complaint, shoulder pain and disability sustained. Compared to the UMC group the total costs were higher in the manipulative group (€1167 vs. €555). This is explained mainly by the costs of the manipulative therapy itself and the higher costs due sick leave from work. The cost effectiveness ratio showed that additional manipulative treatment is more costly but also more effective than UMC alone. The cost-effectiveness acceptability curve shows that a 50%-probability of recovery with AMT within 6 months after initiation of treatment is achieved at €2876.
Manipulative therapy in addition to UMC accelerates recovery and is more effective than UMC alone on the long term, but is associated with higher costs.
International Standard Randomized Controlled Trial Number Register
The aim of the present study was to evaluate the cost-effectiveness of tailored print communication (TPC), telephone motivational interviewing (TMI), a combination of the two, and no intervention on two outcomes in adults aged 45 to 70, half of them having hypertension: increasing the number of public health guidelines met for three behaviors (physical activity and fruit and vegetable consumption), and impact on quality adjusted life years (QALYs).
Participants (n = 1,629) from 23 Dutch general practices were randomized into one of four groups, which received 4 TPCs, 4 TMIs, 2 of each (combined), or no intervention (control), respectively. The self-reported outcomes, measured at baseline and 73 weeks follow-up (7 months after the last intervention component), were difference in total number of guidelines met at follow-up compared to baseline, and number of QALYs experienced over 73 weeks. The costs of implementing the intervention were estimated using a bottom-up approach.
At 73 weeks follow-up participants showed increased adherence with 0.62 (TPC), 0.40 (TMI), 0.50 (combined), and 0.26 (control) guidelines compared to baseline, and experienced 1.09, 1.08, 1.08, and 1.07 QALYs, respectively. The costs for the control group were considered to be zero. TMI was more expensive (€107 per person) than both the combined intervention (€80) and TPC (€57). The control condition was most cost-effective for lower ceiling ratios, while TPC had the highest probability of being most cost-effective for higher ceiling ratios (more than €160 per additional guideline met, and €2,851 for each individual QALY).
For low society's willingness to pay, the control group was most cost-effective for the number of QALYs experienced over 73 weeks. This also applied to the increase in the number of guidelines met at lower ceiling ratios, whereas at higher ceiling ratios, TPC had a higher probability of being more cost-effective than the TMI, combined or control conditions. This also seemed to apply for QALYs experienced over 73 weeks. More research is needed on the long-term efficacy of both TPC and TMI, as well as on how to increase their cost-effectiveness.
Dutch Trial Register NTR1068
Objectives: To investigate the methods used to estimate the indirect costs of health-related productivity in economic evaluations from a company’s perspective. Methods: The primary literature search was conducted in Medline and Embase. Supplemental searches were conducted in the Cochrane NHS Economic Evaluation Database, the National Institute for Occupational Safety and Health database, the Ryerson International Labour, Occupational Safety and Health Index database, scans of reference lists and researcher’s own literature database. Article selection was conducted independently by two researchers based on title, keywords, and abstract, and if needed, full text. Differences were resolved by a consensus procedure. Articles were selected based on seven criteria addressing study population, type of intervention, comparative intervention, outcome, costs, language and perspective, respectively. Characteristics of the measurement and valuation of health-related productivity were extracted and analyzed descriptively. Results: A total of 34 studies were included. Costs of health-related productivity were estimated using (a combination of) data related to sick leave, compensated sick leave, light or modified duty or work presenteeism. Data were collected from different sources (e.g. administrative databases, worker self-report, supervisors) and by different methods (e.g. questionnaires, interviews). Valuation varied in terms of reported time units, composition and source of the corresponding price weights, and whether additional elements, such as replacement costs, were included. Conclusions: Methods for measuring and valuing health-related productivity vary widely, hindering comparability of results and decision-making. We provide suggestions for improvement.
Systematic review; Work; Methodology; Measurement; Valuation; Company
Low back pain (LBP) is a common and disabling disorder in western society. The management of LBP comprises a range of different intervention strategies including surgery, drug therapy, and non-medical interventions. The objective of the present study is to determine the effectiveness of physical and rehabilitation interventions (i.e. exercise therapy, back school, transcutaneous electrical nerve stimulation (TENS), low level laser therapy, education, massage, behavioural treatment, traction, multidisciplinary treatment, lumbar supports, and heat/cold therapy) for chronic LBP. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to 22 December 2008. Existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria. The search strategy outlined by the Cochrane Back Review Groups (CBRG) was followed. The following were included for selection criteria: (1) randomized controlled trials, (2) adult (≥18 years) population with chronic (≥12 weeks) non-specific LBP, and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias, and outcomes at short, intermediate, and long-term follow-up. The GRADE approach was used to determine the quality of evidence. In total 83 randomized controlled trials met the inclusion criteria: exercise therapy (n = 37), back school (n = 5), TENS (n = 6), low level laser therapy (n = 3), behavioural treatment (n = 21), patient education (n = 1), traction (n = 1), and multidisciplinary treatment (n = 6). Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. Behavioural treatment was found to be effective in reducing pain intensity at short-term follow-up compared to no treatment/waiting list controls. Finally, multidisciplinary treatment was found to reduce pain intensity and disability at short-term follow-up compared to no treatment/waiting list controls. Overall, the level of evidence was low. Evidence from randomized controlled trials demonstrates that there is low quality evidence for the effectiveness of exercise therapy compared to usual care, there is low evidence for the effectiveness of behavioural therapy compared to no treatment and there is moderate evidence for the effectiveness of a multidisciplinary treatment compared to no treatment and other active treatments at reducing pain at short-term in the treatment of chronic low back pain. Based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusion on the clinical effect of back schools, low-level laser therapy, patient education, massage, traction, superficial heat/cold, and lumbar supports for chronic LBP.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-010-1518-3) contains supplementary material, which is available to authorized users.
Systematic review; Exercise; Back school; TENS; Education; Multidisciplinary; Behavioural; Effectiveness of interventions; Efficacy; Low back pain; Meta-analyses; Treatment effects; Rehabilitation; Conservative
The objective of this study is to evaluate the effectiveness and safety of total disc replacement surgery compared with spinal fusion in patients with symptomatic lumbar disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total disc replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the total disc replacement was compared with lumbar fusion techniques. The Charité trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charité artificial disc was non-inferior to the BAK® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The Prodisc artificial disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the total disc replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charité is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR.
Degenerative disc degeneration; Low back pain; Total disc replacement; Systematic review
Injection therapy and denervation procedures are commonly used in the management of chronic low-back pain (LBP) despite uncertainty regarding their effectiveness and safety. To provide an evaluation of the current evidence associated with the use of these procedures, a systematic review was performed. Existing systematic reviews were screened, and the Cochrane Back Review Group trial register was searched for randomized controlled trials (RCTs) fulfilling the inclusion criteria. Studies were included if they recruited adults with chronic LBP, evaluated the use of injection therapy or denervation procedures and measured at least one clinically relevant outcome (such as pain or functional status). Two review authors independently assessed studies for eligibility and risk of bias (RoB). A meta-analysis was performed with clinically homogeneous studies, and the GRADE approach was used to determine the quality of evidence. In total, 27 RCTs were included, 14 on injection therapy and 13 on denervation procedures. 18 (66%) of the studies were determined to have a low RoB. Because of clinical heterogeneity, only two comparisons could be pooled. Overall, there is only low to very low quality evidence to support the use of injection therapy and denervation procedures over placebo or other treatments for patients with chronic LBP. However, it cannot be ruled out that in carefully selected patients, some injection therapy or denervation procedures may be of benefit.
Injection; Back pain; Denervation; Review
Systematic reviews have shown that exercise therapy and spinal manipulation are both more effective for low back pain (LBP) than no treatment at all. However, the effects are at best modest. To enhance the clinical outcomes, recommendations are to improve the patient selection process, and to identify relevant subgroups to guide clinical decision-making. One of the systems that has potentials to improve clinical decision-making is a treatment-based classification system that is intended to identify those patients who are most likely to respond to direction-specific exercises, manipulation, or stabilisation exercises.
The primary aim of this randomised controlled trial will be to assess the effectiveness of a classification-based system. A sample of 150 patients with subacute and chronic LBP who attend a private physical therapy clinic for treatment will be recruited. At baseline, all participants will undergo a standard evaluation by trained research physical therapists and will be classified into one of the following subgroups: direction-specific exercises, manipulation, or stabilisation. The patient will not be informed about the results of the examination. Patients will be randomly assigned to classification-based treatment or usual care according to the Dutch LBP guidelines, and will complete questionnaires at baseline, and 8, 26, and 52 weeks after the start of the treatment. The primary outcomes will be general perceived recovery, functional status, and pain intensity. Alongside this trial, an economic evaluation of cost-effectiveness and cost-utility will be conducted from a societal perspective.
The present study will contribute to our knowledge about the effectiveness and cost-effectiveness of classification-based treatment in patients with LBP.
Trial registration number: NTR1176
The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to December 22, 2008. Randomised controlled trials (RCTs) of adults with chronic non-specific LBP, which evaluated at least one clinically relevant, patient-centred outcome measure were included. Two authors working independently from one another assessed the risk of bias using the criteria recommended by the CBRG and extracted the data. The data were pooled when clinically homogeneous and statistically possible or were otherwise qualitatively described. GRADE was used to determine the quality of the evidence. In total, 35 RCTs (8 SMT, 20 acupuncture, 7 herbal medicine), which examined 8,298 patients, fulfilled the inclusion criteria. Approximately half of these (2 SMT, 8 acupuncture, 7 herbal medicine) were thought to have a low risk of bias. In general, the pooled effects for the studied interventions demonstrated short-term relief or improvement only. The lack of studies with a low-risk of bias, especially in regard to SMT precludes any strong conclusions; however, the principal findings, which are based upon low- to very-low-quality evidence, suggest that SMT does not provide a more clinically beneficial effect compared with sham, passive modalities or any other intervention for treatment of chronic low-back pain. There is evidence, however, that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Although there are some good results for individual herbal medicines in short-term individual trials, the lack of homogeneity across studies did not allow for a pooled estimate of the effect. In general, these results are in agreement with other recent systematic reviews on SMT, but in contrast with others. These results are also in agreement with recent reviews on acupuncture and herbal medicine. Randomized trials with a low risk of bias and adequate sample sizes are direly needed.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-010-1356-3) contains supplementary material, which is available to authorized users.
Systematic review; Spinal manipulative therapy; Acupuncture; Herbal medicine; Low-back pain