Review ArticleCan cost utility evaluations inform decision making about interventions for low back pain?
Introduction
A recent study in the United States estimated that annual direct medical costs for spine problems—including low back pain (LBP)—had doubled from $52 to $102 billion in only 7 years, whereas the proportion of persons with spine problems reporting limitations in activities of daily living rose nearly 20% for the same period [1]. These findings highlight the challenges faced by those involved in the management of LBP, including general practitioners (GP), specialist physicians from a variety of disciplines, allied health providers, complementary and alternative medicine (CAM) providers, as well as patients, third-party payers, and policy makers. Every day, stakeholders are faced with selecting from among the hundreds of available interventions, such as medication, education, physical therapy, manual therapy, exercise therapy, cognitive behavioral therapy, injections, surgery, and CAM [2]. Although all claim to improve LBP, they often lack strong evidence to support their efficacy and safety [2].
When faced with such difficult choices, the consideration of cost-effectiveness could perhaps be used to guide these decisions. Some have even suggested that cost-effectiveness be given priority over clinical effectiveness when confronted with numerous comparable interventions [3]. Cost utility analysis (CUA) examines cost-effectiveness using health outcomes valued using scores that typically range from 0 (worst health) to 1 (best health). Depending on how they are obtained, these scores can be viewed as “utility,” which measures one's preference for certain states of health. Utility is often estimated from instruments such as the short form 36 (SF-36) or the EuroQOL (EQ-5D) [4]. By combining utility with survival it is possible to calculate quality-adjusted life year (QALY), a popular outcome for CUAs [5].
For example, the health of a patient who survives 2 years with severe LBP at a utility of 0.5 would be rated at 1.0 QALYs. If an intervention were to increase utility to 0.75 over that period, the patient would gain 0.5 QALYs. By estimating the cost implications of that intervention (eg, physician charges, facility fees, supplies), it would be possible to estimate the incremental cost per QALY gained. If the intervention cited in the example had net costs of $10,000, its incremental cost utility would be $20,000 per QALY. Although the desirable economic efficiency of interventions remains undefined, government agencies have operationalized a threshold [6]. In the United Kingdom, for instance, the National Institute for Clinical Excellence has decided that interventions costing more than 30,000 pounds (∼50,000 US dollars [USD]) per QALY are not cost effective [7]. In the United States, no such formal threshold exists and there have been calls to avoid using one; values as high as $100,000 per QALY have been discussed [6].
By measuring utility and costs in a randomized controlled trial (RCT), it is possible to compare the efficiency of two or more interventions. When one intervention generates lower net costs and provides more QALYs, it is said to “dominate” the other. If it not only generates higher net costs but also provides more QALYs, then the incremental cost-effectiveness ratio (ICER) expresses its efficiency relative to the other intervention. The ICER is defined as the difference in costs between two interventions divided by the difference in the value of health gains between those interventions [8]. Because there is often uncertainty about cost estimates and utility scores, researchers will also report results as the cumulative frequency with which various analyses using different values result in an ICER below a particular value, often termed the willingness-to-pay threshold [9].
The primary objective of this study was to summarize the methods and results of CUAs based on clinical trials of interventions for LBP to determine whether this information could help inform decision makers about which treatment approach is preferred from a cost-effectiveness viewpoint. Secondary objectives were to outline important methodological and reporting issues pertinent to interpreting results of CUAs and to identify the areas of priority research for future CUAs.
Section snippets
Search
A search of the MEDLINE database was conducted on January 14, 2009, using the Ovid interface to combine medical subject headings with modifiers and free-text terms. A search of the National Health Service Economic Evaluation Database (NHS EED) was also conducted using the terms “back pain.”
Screening
Search results were screened independently by two reviewers (SD, DMR) for relevance. Level 1 screening was based on available search results (eg, title, keywords, abstract) to determine whether the citation
Searching and screening
The MEDLINE search yielded 234 citations, of which 189 were deemed irrelevant, 18 were potentially relevant [6], [7], [8], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21], [22], [23], [24], and 27 were of uncertain relevance [3], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38], [39], [40], [41], [42], [43], [44], [45], [46], [47], [48], [49], [50]. The NHS EED search yielded 140 citations, of which 51 were duplicates, 86 were irrelevant,
Discussion
Given the large number of RCTs published on interventions for LBP in the past decade, it was disappointing to uncover only 15 CUAs. These findings confirmed the general paucity of data related to cost-effectiveness in this clinical area [18]. There were only two CUAs from the United States, consistent with the findings from a recent review of cost of LBP studies [54]. Possible explanations for the low number of studies on this topic include inadequate research funding, lack of awareness as to
Conclusions
Although several CUAs of interventions for LBP were identified and reviewed, their clinical heterogeneity, methodological heterogeneity, and poor reporting made it difficult to draw firm conclusions as to the most cost-effective treatment approach for this challenging condition. Findings from some studies suggested that certain types of fusion surgery are superior to other surgical approaches, whereas other studies reported that intensive rehabilitation was superior to fusion surgery.
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FDA device/drug status: not applicable.
Author disclosures: SH (royalties, multiple publishing companies; stock ownership, Palladian Health; consulting, Palladian Health, NCMIC Foundation, New York University; speaking/teaching arrangement, multiple organizations; trips/travel, multiple meetings per prior field; scientific advisory board, NYCC; other office, WFC Research Council); SD (consultant, Palladian Health).
This study was partially funded by an unrestricted research grant provided to the primary author (SD) from the NCMIC Foundation.