Abstract
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.
Introduction
Low back pain (LBP) and neck pain (NP) are widespread health problems and major causes of disability . Lifetime prevalence estimates of LBP and NP range from 60% to 70% and 14% to 71%, respectively . In the European Union (EU), LBP represents the second highest cause of morbidity measured by disability-adjusted life years and NP the tenth highest cause . The economic impact of LBP and NP is considerable. In the United Kingdom, for example, the total annual societal cost of back pain was estimated to be £12.3 billion . In the Netherlands, the total annual societal cost of back pain and NP was estimated to be €3.5 billion and $0.7 billion, respectively . In all these estimates, the majority of costs were attributed to productivity losses .
The high prevalence and economic burden of LBP and NP have spawned the development of a broad range of treatments . As resources are scarce, however, healthcare decision-makers increasingly call upon their advisors and researchers to not only demonstrate that such treatments are effective but also efficient in terms of their resource implications. Economic evaluations can provide this information by comparing alternative treatments in terms of both their costs and health effects .
In recent years, economic evaluations have become more and more integrated in the planning of many European health systems . At the same time, the availability of health economic evidence has increased dramatically, as evidenced by the large number of citations in specialist health economic databases. As early as 2005, for example, the NHS Economic Evaluation Database and Health Economic Evaluation Database counted over 16,000 and 31,750 citations, respectively .
Despite the increased interest in economic evaluations and the growing body of health economic evidence, there are difficulties in applying the evidence in practice. Reasons for this include a lack of understanding of economic evaluation methods, a lack of time to find and appraise evidence when decisions are needed quickly, timeliness of published evidence, and a perception among decision-makers that economic evidence may be biased or based on inappropriate assumptions. In addition, relevant economic evidence may simply not be available .
The “Research Agenda for Health Economic Evaluation” (RAHEE) project was initiated by the World Health Organization in partnership with the European Commission Consumer, Health, Agriculture and Food executive Agency. The aim was to identify gaps in the economic evidence for health interventions, and translational and methodological challenges that, if addressed, could improve the use of health economic evidence in practice . The results of the RAHEE project form the basis of a research agenda on health economic evaluations for the EU. The project focused on the 10 conditions with the highest burden of illness in the EU , and crosscutting methodological and translational issues. The current paper has arisen as part of the RAHEE project and aimed to identify economic evidence gaps and methodological constraints in the LBP and NP literature.
Methods
To examine the extent of economic evidence available for LBP and NP, a literature-mapping process was undertaken depending on two components. First, treatment modalities used in routine clinical practice for LBP and NP were categorized and summarized according to a clinical guidelines database, producing treatment stratification tables. Second, all economic evidences for the management of LBP or NP indexed by a major biomedical literature database (MEDLINE accessed through PubMed) were identified and placed into the appropriate sections of the treatment stratification tables, and the available evidence for each treatment was summarized narratively .
Similar exercises were undertaken for all focus areas of the RAHEE project. Subsequently, a public consultation was held and an Expert Panel of leading health economists and public health experts was assembled .
Treatment stratification tables
As a framework for considering the economic evidence, treatment stratification tables for the management of LBP and NP were produced. For both conditions, the Up-to-Date database ( ) was searched for clinical guidelines and expert opinions, which were synthesized in a table. The LBP and NP tables were structured first by disease characteristics (i.e., acute, subacute/chronic) and subsequently by treatment characteristics (e.g., Pharmacology, Activity and Physical Treatments) .
Literature search
Relevant reviews and primary studies were identified by searching MEDLINE (accessed through PubMed) using the following MeSH terms: “Cost-Benefit Analysis [N03.219.151.125],” “Economics, Pharmaceutical [N03.219.390],” “Technology Assessment, Biomedical [N03.880]” (including “Technology, High-Cost [N03.880.502]”), “Low Back Pain [D.017.116],” and “Neck Pain [D.019.547].” The search was conducted in August 2014. Identified titles and abstracts were screened by one reviewer, and, if necessary, full texts were retrieved to determine eligibility for inclusion. Inclusion criteria were full economic evaluation of an LBP and/or NP treatment (i.e., cost–benefit, cost-effectiveness, cost–utility) or review addressing economic evaluations of LBP and/or NP treatments and English abstract. Studies without an integrated effectiveness component (e.g., cost of illness, cost of treatment) were excluded. Geographical limitations were not imposed. Reviews had to be published after January 1, 2009, but for primary studies, there was no cut-off year .
Evidence review, public consultation, and Expert Panel meeting
A literature database was constructed, in which all of the included reviews and primary studies were placed in the aforementioned treatment stratification tables. Studies were categorized according to all comparators included . Narrative reviews were produced to summarize the available evidence for LBP and NP separately. The narrative reviews were open for public consultation between November 25th and December 29th, 2014. Comments received through the public consultation were incorporated in the final versions of the narrative reviews . Subsequently, high-level public health experts were invited to join the RAHEE Expert Panel in order to provide links with the policy cycle . The Expert Panel assembled in Brussels, from February 3rd to February 5th, 2015, for a meeting where the results of the literature mapping were discussed. Discussions focused on limitations of the existing evidence, evidence gaps, and methodological constraints arising from the literature .
Methods
To examine the extent of economic evidence available for LBP and NP, a literature-mapping process was undertaken depending on two components. First, treatment modalities used in routine clinical practice for LBP and NP were categorized and summarized according to a clinical guidelines database, producing treatment stratification tables. Second, all economic evidences for the management of LBP or NP indexed by a major biomedical literature database (MEDLINE accessed through PubMed) were identified and placed into the appropriate sections of the treatment stratification tables, and the available evidence for each treatment was summarized narratively .
Similar exercises were undertaken for all focus areas of the RAHEE project. Subsequently, a public consultation was held and an Expert Panel of leading health economists and public health experts was assembled .
Treatment stratification tables
As a framework for considering the economic evidence, treatment stratification tables for the management of LBP and NP were produced. For both conditions, the Up-to-Date database ( ) was searched for clinical guidelines and expert opinions, which were synthesized in a table. The LBP and NP tables were structured first by disease characteristics (i.e., acute, subacute/chronic) and subsequently by treatment characteristics (e.g., Pharmacology, Activity and Physical Treatments) .
Literature search
Relevant reviews and primary studies were identified by searching MEDLINE (accessed through PubMed) using the following MeSH terms: “Cost-Benefit Analysis [N03.219.151.125],” “Economics, Pharmaceutical [N03.219.390],” “Technology Assessment, Biomedical [N03.880]” (including “Technology, High-Cost [N03.880.502]”), “Low Back Pain [D.017.116],” and “Neck Pain [D.019.547].” The search was conducted in August 2014. Identified titles and abstracts were screened by one reviewer, and, if necessary, full texts were retrieved to determine eligibility for inclusion. Inclusion criteria were full economic evaluation of an LBP and/or NP treatment (i.e., cost–benefit, cost-effectiveness, cost–utility) or review addressing economic evaluations of LBP and/or NP treatments and English abstract. Studies without an integrated effectiveness component (e.g., cost of illness, cost of treatment) were excluded. Geographical limitations were not imposed. Reviews had to be published after January 1, 2009, but for primary studies, there was no cut-off year .
Evidence review, public consultation, and Expert Panel meeting
A literature database was constructed, in which all of the included reviews and primary studies were placed in the aforementioned treatment stratification tables. Studies were categorized according to all comparators included . Narrative reviews were produced to summarize the available evidence for LBP and NP separately. The narrative reviews were open for public consultation between November 25th and December 29th, 2014. Comments received through the public consultation were incorporated in the final versions of the narrative reviews . Subsequently, high-level public health experts were invited to join the RAHEE Expert Panel in order to provide links with the policy cycle . The Expert Panel assembled in Brussels, from February 3rd to February 5th, 2015, for a meeting where the results of the literature mapping were discussed. Discussions focused on limitations of the existing evidence, evidence gaps, and methodological constraints arising from the literature .
Results
A detailed description of the RAHEE project’s results can be found elsewhere , including the full evidence mapping for LBP and NP. Below, the LBP and NP treatment stratification tables are discussed and a summary is provided of the evidence mapping for LBP and NP.
Treatment stratification tables
Three treatment stratification tables were developed:
- •
Acute LBP , 18 treatment modalities including “Pharmacological Interventions,” “Activity and Physical Treatments,” and “Injections” ( Table 1 ).
Table 1
Reviews and primary studies identified for various acute LBP treatment modalities (n = 18).
Acute low back pain treatment options
Primary studies
Reviews
Pharmacology
Acetaminophen
1
0
Muscle relaxants
0
0
Nonsteroidal anti-inflammatory medications: ketorolac, meperidine, ibuprofen, naproxen
1
0
Opioids
0
0
Activity and physical treatments
Acupuncture
1
0
Cold/heat (heat wrap)
1
0
Corsets/braces
0
0
Massage therapy
0
0
Mattress recommendations
0
0
Physical therapy/exercise program
2
0
Spinal manipulation
2
2
Traction
0
0
Yoga
0
0
Injections into trigger points, epidural space, facet joint, or sacroiliac joint
Botulinum toxin
0
0
Local anesthetics
0
0
Oxygen–ozone mixtures
0
0
Proliferant-sclerosing solutions (known as prolotherapy or sclerotherapy)
0
0
TNF-alpha inhibitors
0
0
- •
Subacute/chronic LBP , 46 treatment modalities including “Pharmacological Interventions,” “Activity and Physical Treatments,” “Psychological and Multidisciplinary Interventions,” “Physical Modalities,” “Interventional Diagnostic Procedures,” “Injections,” “Electrothermal and Radiofrequency Therapies,” and “Surgical Treatment” ( Table 2 ).
Table 2
Reviews and primary studies identified for various subacute and chronic LBP treatment modalities (n = 46).
Subacute/Chronic low back pain treatment options
Primary studies
Reviews
Pharmacology
Antidepressants: trazodone, duloxetine, tricyclic antidepressants
2
0
Antiepileptics: gabapentin, pregabalin, topiramate
0
0
Anti-TNF-alpha therapy
0
0
Benzodiazepines: tetrazepam
0
0
Glucosamine
0
0
Herbal therapies: Harpagophytym procumbens (Devil’s claw), Salix alba (White willow bark), and topical Sapsicum frutescens (Cayenne)
0
0
Local anesthetics: lidocaine patches
0
0
Muscle relaxants: cyclobenzaprine, flupirtine, tolperisone, carisoprodol, meprobamate
1
0
Nonsteroidal anti-inflammatory medications: acetaminophen, ketorolac, meperidine, ibuprofen, naproxen
1
0
Opioids: tramadol, codeine phosphate/acetaminophen
2
0
Steroids: methylprednisolone
0
0
Activity and physical treatments
Acupuncture
6
3
Back schools
2
3
Exercise therapy/physical therapy
21
4
Massage therapy
1
1
Spinal manipulation
5
4
Traction/corsets/braces
3
0
Yoga
1
0
Psychological and multidisciplinary interventions
Cognitive-behavioral therapy
15
3
Functional restoration
0
0
Interdisciplinary rehabilitation
0
0
Physical modalities
Interferential therapy
0
0
Low-level laser therapy
0
0
Pulsed short-wave diathermy
0
0
Traction
0
0
Transcutaneous or percutaneous electrical nerve stimulation
2
1
Therapeutic ultrasound
0
0
Interventional diagnostic procedures
Diagnostic nerve root blocks
0
0
Discography
0
0
Facet joint blocks
1
0
Sacroiliac joint blocks
0
0
Injections
Epidural: glucocorticoids, etanercept
0
0
Facet joint: glucocorticoids, etanercept
0
0
Intradiscal: glucocorticoids, etanercept, chemonucleolysis, methylene blue
0
0
Local or trigger point: glucocorticoids, etanercept
0
0
Medial branch block: glucocorticoids, etanercept
0
0
Piriformis syndrome: glucocorticoids
0
0
Paravertebral: botulinum toxin
0
0
Sacroiliac joint: glucocorticoids, etanercept
0
0
Electrothermal and radiofrequency therapies
Intradiscal therapy: Intradiscal electrothermal therapy and percutaneous intradiscal radiofrequency thermocoagulation
1
0
Prolotherapy
0
0
Radiofrequency denervation
2
0
Surgical treatment
Lumbar disc replacement
2
0
Microdiscectomy
2
1
Spinal fusion
7
2
Standard open discectomy
2
1 Related posts:
Evidence and methods in back pain research
Clinical guidelines for low back pain: A critical review of consensus and inconsistencies across three major guidelines
The prevalence, risk factors, prognosis and treatment for back pain in children and adolescents: An overview of systematic reviews
Causal mechanisms in the clinical course and treatment of back pain
Developing implementation science to improve the translation of research to address low back pain: A critical review
Decision support tools in low back pain
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