Update of Markov Model on the Cost-effectiveness of Nonpharmacologic Interventions for Chronic Low Back Pain Compared to Usual Care.

STUDY DESIGN: Markov model. OBJECTIVE: Further validity test of a previously published model. SUMMARY OF BACKGROUND DATA: The previous model was built using data from ten randomized trials and examined the 1-year effectiveness and cost-effectiveness of 17 nonpharmacologic interventions for chronic low back pain (CLBP), each compared to usual care alone. This update incorporated data from five additional trials. METHODS: Based on transition probabilities that were estimated using patient-level trial data, a hypothetical cohort of CLBP patients transitioned over time among four defined health states: high-impact chronic pain with substantial activity limitations; higher (moderate-impact) and lower (low-impact) pain without activity limitations; and no pain. As patients transitioned among health states, they accumulated quality-adjusted life-years, as well as healthcare and productivity costs. Costs and effects were calculated incremental to each study's version of usual care. RESULTS: From the societal perspective and assuming a typical patient mix (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain), most interventions-including those newly added-were cost-effective (<$50,000/QALY) and demonstrated cost savings. From the payer perspective, fewer were cost-saving, but the same number were cost-effective. Results for the new studies generally mirrored others using the same interventions-for example, cognitive behavioral therapy (CBT) and physical therapy. A new acupuncture study had similar effectiveness to other acupuncture studies, but higher usual care costs, resulting in higher cost savings. Two new yoga studies' results were similar, but both differed from those of the original yoga study. Mindfulness-based stress reduction was similar to CBT for a typical patient mix but was twice as effective for those with high-impact chronic pain. CONCLUSION: Markov modeling facilitates comparisons across interventions not directly compared in trials, using consistent outcome measures after balancing the baseline mix of patients. Outcomes also differed by pain impact level, emphasizing the need to measure CLBP subgroups. LEVEL OF EVIDENCE: N/A.

The impact of patient preferences and costs on the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain.

BACKGROUND: Although the delivery of appropriate healthcare is an important goal, the definition of what constitutes appropriate care is not always agreed upon. The RAND/UCLA Appropriateness Method is one of the most well-known and used approaches to define care appropriateness from the clinical perspective-i.e., that the expected effectiveness of a treatment exceeds its expected risks. However, patient preferences (the patient perspective) and costs (the healthcare system perspective) are also important determinants of appropriateness and should be considered. METHODS: We examined the impact of including information on patient preferences and cost on expert panel ratings of clinical appropriateness for spinal mobilization and manipulation for chronic low back pain and chronic neck pain. RESULTS: The majority of panelists thought patient preferences were important to consider in determining appropriateness and that their inclusion could change ratings, and half thought the same about cost. However, few actually changed their appropriateness ratings based on the information presented on patient preferences regarding the use of these therapies and their costs. This could be because the panel received information on average patient preferences for spinal mobilization and manipulation whereas some panelists commented that appropriateness should be determined based on the preferences of individual patients. Also, because these therapies are not expensive, their ratings may not be cost sensitive. The panelists also generally agreed that preferences and costs would only impact their ratings if the therapies were considered clinically appropriate. CONCLUSIONS: This study found that the information presented on patient preferences and costs for spinal mobilization and manipulation had little impact on the rated appropriateness of these therapies for chronic low back pain and chronic neck pain. Although it was generally agreed that patient preferences and costs were important to the appropriateness of M/M for CLBP and CNP, it seems that what would be most important were the preferences of the individual patient, not patients in general, and large cost differentials.

Health Care Costs and Opioid Use Associated With High-impact Chronic Spinal Pain in the United States.

STUDY DESIGN: A descriptive analysis of secondary data. OBJECTIVE: The aim of this study was to estimate health care costs and opioid use for those with high-impact chronic spinal (back and neck) pain. SUMMARY OF BACKGROUND DATA: The US National Pain Strategy introduced a focus on high-impact chronic pain-that is, chronic pain associated with work, social, and self-care restrictions. Chronic neck and low-back pain are common, costly, and associated with long-term opioid use. Although chronic pain is not homogenous, most estimates of its costs are averages that ignore severity (impact). METHODS: We used 2003 to 2015 Medical Expenditures Panel Survey (MEPS) data to identify individuals with chronic spinal pain, their health care expenditures, and use of opioids. We developed prediction models to identify those with high- versus moderate- and low-impact chronic spinal pain based on the variables available in MEPS. RESULTS: We found that overall and spine-related health care costs, and the use and dosage of opioids increased significantly with chronic pain impact levels. Overall and spine-related annual per person health care costs for those with high-impact chronic pain ($14,661 SE: $814; and $5979 SE: $471, respectively) were more than double that of those with low-impact, but still clinically significant, chronic pain ($6371 SE: $557; and $2300 SE: $328). Those with high-impact chronic spinal pain also use spine-related opioids at a rate almost four times that of those with low-impact pain (48.4% vs. 12.4%), and on average use over five times the morphine equivalent daily dose (MEDD) in mg (15.3 SE: 1.4 vs. 2.7 SE: 0.6). Opioid use and dosing increased significantly across years, but the increase in inflation-adjusted health care costs was not statistically significant. CONCLUSION: Although most studies of chronic spinal pain do not differentiate participants by the impact of their chronic pain, these estimates highlight the importance of identifying chronic pain levels and focusing on those with high-impact chronic pain. LEVEL OF EVIDENCE: 3.

Patient Willingness to Pay for Reductions in Chronic Low Back Pain and Chronic Neck Pain.

Many recommended nonpharmacologic therapies for patients with chronic spinal pain require visits to providers such as acupuncturists and chiropractors. Little information is available to inform third-party payers' coverage policies regarding ongoing use of these therapies. This study offers contingent valuation-based estimates of patient willingness to pay (WTP) for pain reductions from a large (n = 1,583) sample of patients using ongoing chiropractic care to manage their chronic low back and neck pain. Average WTP estimates were $45.98 (45.8) per month per 1-point reduction in current pain for chronic low back pain and $37.32 (38.0) for chronic neck pain. These estimates met a variety of validity checks including that individuals' values define a downward-sloping demand curve for these services. Comparing these WTP estimates with patients' actual use of chiropractic care over the next 3 months indicates that these patients are likely "buying" perceived pain reductions from what they believe their pain would have been if they didn't see their chiropractor-that is, they value maintenance of their current mild pain levels. These results provide some evidence for copay levels and their relationship to patient demand, but call into question ongoing coverage policies that require the documentation of continued improvement or of experienced clinical deterioration with treatment withdrawal. PERSPECTIVE: This study provides estimates of reported WTP for pain reduction from a large sample of patients using chiropractic care to manage their chronic spinal pain and compares these estimates to what these patients do for care over the next 3 months, to inform coverage policies for ongoing care.

Are Nonpharmacologic Interventions for Chronic Low Back Pain More Cost Effective Than Usual Care? Proof of Concept Results From a Markov Model.

STUDY DESIGN: Markov model. OBJECTIVE: Examine the 1-year effectiveness and cost-effectiveness (societal and payer perspectives) of adding nonpharmacologic interventions for chronic low back pain (CLBP) to usual care using a decision analytic model-based approach. SUMMARY OF BACKGROUND DATA: Treatment guidelines now recommend many safe and effective nonpharmacologic interventions for CLBP. However, little is known regarding their effectiveness in subpopulations (e.g., high-impact chronic pain patients), nor about their cost-effectiveness. METHODS: The model included four health states: high-impact chronic pain (substantial activity limitations); no pain; and two others without activity limitations, but with higher (moderate-impact) or lower (low-impact) pain. We estimated intervention-specific transition probabilities for these health states using individual patient-level data from 10 large randomized trials covering 17 nonpharmacologic therapies. The model was run for nine 6-week cycles to approximate a 1-year time horizon. Quality-adjusted life-year weights were based on six-dimensional health state short form scores; healthcare costs were based on 2003 to 2015 Medical Expenditure Panel Survey data; and lost productivity costs used in the societal perspective were based on reported absenteeism. Results were generated for two target populations: (1) a typical baseline mix of patients with CLBP (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain) and (2) high-impact chronic pain patients. RESULTS: From the societal perspective, all but two of the therapies were cost effective (<$50,000/quality-adjusted life-year) for a typical patient mix and most were cost saving. From the payer perspective fewer were cost saving, but the same number was cost-effective. Assuming all patients in the model have high-impact chronic pain increases the effectiveness and cost-effectiveness of most, but not all, therapies indicating that substantial benefits are possible in this subpopulation. CONCLUSION: Modeling leverages the evidence produced from clinical trials to provide more information than is available in the published studies. We recommend modeling for all existing studies of nonpharmacologic interventions for CLBP. LEVEL OF EVIDENCE: 4.

Researching the Appropriateness of Care in the Complementary and Integrative Health Professions Part 2: What Every Researcher and Practitioner Should Know About the Health Insurance Portability and Accountability Act and Practice-based Research in the United States.

OBJECTIVE: This paper describes a process for ensuring and documenting Health Insurance Portability and Accountability Act (HIPAA) compliance in clinical practice-based research. METHODS: The Center of Excellence for Research in Complementary and Alternative Medicine was funded by National Center for Complementary and Integrative Health to develop the methods for researching the appropriateness of care in complementary and integrative health, which previously was known as complementary and alternative medicine. We recruited 125 participating chiropractic clinics for enrolling patients and gathering their data via the online surveys. Chiropractic clinics completed the following: (1) obtained the files of patients who provided prior consent (the prospective sample), (2) obtained the files of the patients selected randomly using specified randomization procedures (the retrospective sample), and (3) transferred all patient data to the RAND Corporation via an encrypted file. RESULTS: Most of the doctors of chiropractic from clinical practices had no concerns about obtaining and transferring the files of patients who provided informed consent. However, some doctors were uneasy about allowing the researchers to access the randomly selected files of patients who had not provided prior authorization. This led us to develop a set of forms to provide clinics about HIPAA compliance. CONCLUSION: For this study, we provided clinics with information about the rules under HIPAA, demonstrated how the study complied with those rules, explained the logic behind the necessity for collecting files from both the prospective and retrospective samples, and, if requested, provided clinics with a confidentiality agreement signed by the study principal investigator and an organizational contracts representative. The process we developed may assist other complementary and integrative health researchers and practitioners in future studies.

Economic analysis of complementary, alternative, and integrative medicine: considerations raised by an expert panel.

BACKGROUND: An international panel of experts was convened to examine the challenges faced in conducting economic analyses of Complementary, Alternative and Integrative Medicine (CAIM). METHODS: A one and a half-day panel of experts was convened in early 2011 to discuss what was needed to bring about robust economic analysis of CAIM. The goals of the expert panel were to review the current state of the science of economic evaluations in health, and to discuss the issues involved in applying these methods to CAIM, recognizing its unique characteristics. The panel proceedings were audiotaped and a thematic analysis was conducted independently by two researchers. The results were then discussed and differences resolved. This manuscript summarizes the discussions held by the panel members on each theme. RESULTS: The panel identified seven major themes regarding economic evaluation that are particularly salient to determining the economics of CAIM: standardization (in order to compare CAIM with conventional therapies, the same basic economic evaluation methods and framework must be used); identifying the question being asked, the audience targeted for the results and whose perspective is being used (e.g., the patient perspective is especially relevant to CAIM because of the high level of self-referral and out-of-pocket payment); the analytic methods to be used (e.g., the importance of treatment description and fidelity); the outcomes to be measured (e.g., it is important to consider a broad range of outcomes, particularly for CAIM therapies, which often treat the whole person rather than a specific symptom or disease); costs (e.g., again because of treating the whole person, the impact of CAIM on overall healthcare costs, rather than only disease-specific costs, should be measured); implementation (e.g., highlighting studies where CAIM allows cost savings may help offset its image as an "add on" cost); and generalizability (e.g., proper reporting can enable study results to be useful beyond the study sample). CONCLUSIONS: The business case for CAIM depends on economic analysis and standard methods for conducting such economic evaluations exist. The challenge for CAIM lies in appropriately applying these methods. The deliberations of this panel provide a list of factors to be considered in meeting that challenge.

US spending on complementary and alternative medicine during 2002-08 plateaued, suggesting role in reformed health system.

Complementary and alternative medicine services in the United States are an approximately $9 billion market each year, equal to 3 percent of national ambulatory health care expenditures. Unlike conventional allopathic health care, complementary and alternative medicine is primarily paid for out of pocket, although some services are covered by most health insurance. Examining trends in demand for complementary and alternative medicine services in the United States reported in the Medical Expenditure Panel Survey during 2002-08, we found that use of and spending on these services, previously on the rise, have largely plateaued. The higher proportion of out-of-pocket responsibility for payment for services may explain the lack of growth. Our findings suggest that any attempt to reduce national health care spending by eliminating coverage for complementary and alternative medicine would have little impact at best. Should some forms of complementary and alternative medicine-for example, chiropractic care for back pain-be proven more efficient than allopathic and specialty medicine, the inclusion of complementary and alternative medicine providers in new delivery systems such as accountable care organizations could help slow growth in national health care spending.

Comparative effectiveness research: does the emperor have clothes?

With the recent allocation ofa $1.1 billion "down payment" to fund comparative effectiveness research (CER) from the American Recovery and Reinvestment Act of 2009 (generally referred to as the stimulus package) and with $300 million being allocated for the Agency for Healthcare Research and Quality (AHRQ), $400 million for the National Institutes of Health, and $400 million for allocation at the discretion of the Secretary of Health and Human Services and with the National Center for Complementary Alternative Medicine putting out a request for research proposals for Comparative Effectiveness Studies of Complementary and Alternative Medicine, it is safe to say CER has entered a new era. CER solves two historical concerns for complementary and alternative medicine (CAM) researchers; first it focuses on effectiveness not efficacy; second it tests holistic approaches to care. Because it allows the providers to give care in any way they choose, it avoids the problem of reductionism inherent in standard random controlled trials. In CER, the provider can continue to practice holistically and to use individualized medicine to treat the patient. However, amid the largely positive responses to this move among researches in CAM, a more critical evaluation might be in order. This article argues that while the move to effectiveness research is a positive move for CAM, CER as currently being talked about and funded may just be a new form of privileging certain forms of evidence at the expense of other equally important and perhaps more relevant evidence.

Patient-based outcome assessment instruments in acupuncture research.

BACKGROUND: Outcome assessment can support the therapeutic process by providing a way to track symptoms and functionality over time, providing insights to clinicians and patients, as well as offering a common language to discuss patient behavior/functioning. OBJECTIVES: In this article, we examine the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The aims of this review were to assess and identify the commonly available PBOA measures, describe a framework for identifying appropriate sets of measures, and address the challenges associated with these measures and acupuncture. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. METHODS: This study was a systematic review. A total of 582 abstracts were reviewed using PubMed (from inception through April 2009). RESULTS: A total of 582 citations were identified. After screening of title/abstract, 212 articles were excluded. From the remaining 370 citations, 258 manuscripts identified explicit PBOA; 112 abstracts did not include any PBOA. The five most common PBOA instruments identified were the Visual Analog Scale, Symptom Diary, Numerical Pain Rating Scales, SF-36, and depression scales such as the Beck Depression Inventory. CONCLUSIONS: The way a questionnaire or scale is administered can have an effect on the outcome. Also, developing and validating outcome measures can be costly and difficult. Therefore, reviewing the literature on existing measures before creating or modifying PBOA instruments can significantly reduce the burden of developing a new measure.

Is health services research the Holy Grail of complementary and alternative medicine research?

In a 2006 article in Alternative Therapies in Health and Medicine, Herman et al argued cogently that adopting a health services research (HSR) paradigm would help resolve some of the issues that the complementary and alternative medicine (CAM) community and those researching CAM face with randomized controlled trials. Although the article makes a strong case for HSR and CAM, it fails to discuss some of the work in HSR that is uniquely relevant to CAM or to provide a critique of the view one gets from HSR about CAM. There is within the studies of chiropractic a sufficient body of HSR, which can help to assess what the contribution of HSR has been in the past and also what its limitations are today. It provides a cautionary tale for CAM. This article looks at HSR in relationship to evidence-based practice and will discuss the limitations and dangers of the view of CAM from the perspective of HSR using chiropractic studies as an exemplar.

Oral health findings for HIV-infected adult medical patients from the HIV Cost and Services Utilization Study.

BACKGROUND: The HIV Cost and Services Utilization Study (HCSUS) was conducted by a consortium of private and government institutions centered at the RAND Corp. to provide national estimates of adult medical patients who are HIV-positive. This article presents descriptive oral health findings from that study. METHODS: The National Opinion Research Center (NORC) conducted four interviews of a nationally representative sample of adults with HIV who made a medical visit for regular care in early 1996. This article uses data from the second interview conducted between December 1996 and July 1997. The authors constructed analytical weights for each respondent so the 2,466 interviewees represented a population of 219,700. RESULTS: Most adult medical patients with HIV rated their oral health as at least "good," but 12 percent (representing a population of 25,300) rated it as "poor." Xerostomia was the most commonly reported symptom (37 percent) to arise in the time since the previous interview. Twenty-nine percent had a dental benefit under Medicaid and 23 percent had private insurance. Eighteen percent had not revealed their HIV status to the dentist they usually saw. CONCLUSIONS: National data on adult medical patients with HIV provide a context for local or convenience sample studies and can help give direction to public health and public policy programs directed to the oral health needs of this population. CLINICAL IMPLICATIONS: The attitudes and beliefs of adult HIV patients should be taken into account in the creation of community health education programs and continuing education for dentists. Medicaid programs should include adult dental benefits.

A Self-Report Measure of Clinicians' Orientation toward Integrative Medicine.

OBJECTIVE: Patients in the U.S. often turn to complementary and alternative medicine (CAM) and may use it concurrently with conventional medicine to treat illness and promote wellness. However, clinicians vary in their openness to the merging of treatment paradigms. Because integration of CAM with conventional medicine can have important implications for health care, we developed a survey instrument to assess clinicians' orientation toward integrative medicine. STUDY SETTING: A convenience sample of 294 acupuncturists, chiropractors, primary care physicians, and physician acupuncturists in academic and community settings in California. DATA COLLECTION METHODS: We used a qualitative analysis of structured interviews to develop a conceptual model of integrative medicine at the provider level. Based on this conceptual model, we developed a 30-item survey (IM-30) to assess five domains of clinicians' orientation toward integrative medicine: openness, readiness to refer, learning from alternate paradigms, patient-centered care, and safety of integration. PRINCIPAL FINDINGS: Two hundred and two clinicians (69 percent response rate) returned the survey. The internal consistency reliability for the 30-item total scale and the five subscales ranged from 0.71 to 0.90. Item-scale correlations for the five subscales were higher for the hypothesized subscale than other subscales 75 percent or more of the time. Construct validity was supported by the association of the IM-30 total scale score (0-100 possible range, with a higher score indicative of greater orientation toward integrative medicine) with hypothesized constructs: physician acupuncturists scored higher than physicians (71 versus 50, p<.001), dual-trained practitioners scored higher than single-trained practitioners (71 versus 62, p<.001), and practitioners' self-perceived "integrativeness" was significantly correlated (r=0.60, p<.001) with the IM-30 total score. CONCLUSION: This study provides support for the reliability and validity of the IM-30 as a measure of clinicians' orientation toward integrative medicine. The IM-30 survey, which we estimate as requiring 5 minutes to complete, can be administered to both conventional and CAM clinicians.

Self-reported satisfaction of enrollees in capitated and fee-for-service dental benefit plans.

BACKGROUND: This article examines the impact of capitated, or CAP, and fee-for-service, or FFS, dental benefit plans on the enrollees' satisfaction with their plans and their satisfaction with their dentists. METHODS: The authors selected four dental markets: California, New Jersey, Michigan and North Carolina. Eight Fortune 500 companies participated. Enrollees were selected randomly and interviewed about their experiences with their dental plans. The sample consisted of 2,340 respondents, of whom 42.3 percent were enrolled in CAP plans and 57.7 percent in FFS plans. RESULTS: The major findings were that those enrolled in FFS plans were four times more likely to be very satisfied than dissatisfied with their dental plans than were those in CAP plans. The FFS plan enrollees were 16 times more likely to be very satisfied than dissatisfied with their dentists than were those in CAP plans. CONCLUSION: Enrollees generally were satisfied with their plans and their dentists but those in FFS plans were the most satisfied. The higher the premium paid, the higher the level of satisfaction. PRACTICE IMPLICATIONS: Enrollees with perceived unmet needs were less satisfied with their dental benefit plans and dentists. Taking care of needs is the most significant thing dentists can do to affect patients' satisfaction.