We describe here our study designed to understand clinically meaningful outcomes (from both patient and provider perspectives) of acupuncture and chiropractic (A/C) care as delivered in routine practice settings for the treatment of chronic musculoskeletal pain (CMP). The centerpiece of the study is a prospective cohort study. However, before we undertake this phase of work, we will conduct an analysis of electronic medical record (EMR) data and qualitative data collection to provide the foundation for identifying a more meaningful comparison of outcomes between those receiving and not receiving A/C care. Our goal is to test an exportable methodological approach that can be used to understand critical outcomes associated with the receipt of an array of treatment services in everyday practice settings for a realistically diverse set of patients.
Chronic pain is a highly prevalent condition, often resulting in large decrements in health-related quality of life (QOL) and functional status, with substantial associated medical care costs, disability, and productivity loss [1
]. CMP in particular is both prevalent and costly [4
], affecting 60-80% of American adults at some point during their lives; CMP symptoms are among the top five reasons that patients visit clinics and emergency departments [6
]. Recent alarming increases in delivery of opioid treatment and surgical interventions for chronic pain--despite their high costs, potential adverse effects, and modest efficacy [9
]--suggest the need to evaluate outcomes associated with promising non-pharmacological/non-surgical approaches for CMP management and treatment, including complementary and alterative medicine (CAM). Americans seek CAM treatments far more often for CMP than for any other condition [13
Substantial recent research has examined the biological basis and efficacy of many types of CAM therapies but, despite calls for effectiveness-oriented research, "real-world" use of CAM remains understudied [14
]. Use of CAM for CMP appears to be increasing. A national survey [13
] found that 38% of U.S. adults used some form of CAM, most commonly for relief of back and neck pain, joint pain and stiffness, arthritis, and other musculoskeletal conditions. Among CAM treatments for CMP, acupuncture and chiropractic care are considered the most highly accepted by physician groups [16
] with the best evidence to support their use [18
]. Nearly 90% of states mandate insurance reimbursement for chiropractic care and approximately 25% do so for acupuncture [22
]. Further, a survey of acupuncturists and chiropractors in Massachusetts, Arizona, and Washington found that back pain was the most common reason given by patients for seeking treatments; overall, 40-76% of patients included CMP among their reasons for seeking such treatment [23
Patients also report high levels of satisfaction with acupuncture [24
] and chiropractic care [18
]. A Consumer Reports survey found that while more than half of the respondents reported being highly satisfied with care from acupuncturists (53%) and chiropractors (59%) for back pain, only 44% reported similar satisfaction with care from specialist physicians and 34% with care from primary care physicians [25
]. Despite some positive findings among observational studies and randomized controlled trials (RCTs) regarding the impact of acupuncture [18
] and chiropractic care [18
] on CMP, highly controlled trials have suggested that expectation and non-specific effects may be substantial contributors to observed treatment effects [31
]. These findings highlight the importance of examining patient expectations and treatment decision-making factors when evaluating such outcomes. Given both the popularity of A/C for CMP treatment and outcome findings, an important next step is to examine the use of these CAM therapies for CMP as they are delivered by providers in routine practice settings.
Multiple recent reports [14
] suggest the importance for health services research to explore models of organized health delivery that integrate CAM with conventional medicine. Until recently, patients were likely to make decisions about whether to use CAM services without input from allopathic providers [36
], but today's patients are increasingly "co-managed" by conventional and CAM clinicians. Most patients report using CAM and conventional medicine together and want the opportunity to discuss CAM use with their primary care providers, be respected for their beliefs, and be guided on their use of such treatments [38
]. Many CAM therapies are used to complement, rather than replace, conventional medicine; therefore, it is important to identify a model that can serve as a unified framework for the decision to use A/C within this context. Thus, we chose a framework to guide our exploration of patients' decisions to use A/C based on a well-accepted model for general health care decision-making and use [41
], that has been expanded to consider integration of CAM services (see Figure )[43
]. This model for CAM use includes commonly used self-directed practices and products as well as provider services that are the central focus of this study. Further, the model includes indicators that may "pull" a person toward A/C use (e.g., responsibility for preventive self-care) or "push" patients (e.g., dissatisfaction with conventional medicine)[44
]. Research on conventional medicine use suggests that enabling factors (e.g., access, information about forms of care) and need (e.g., type and level of impairment) are the primary drivers of health care decisions [46
], but their relative importance has not been explored for A/C service use.
Patient Factors Influencing the Decision to Use Acupuncture and/or Chiropractic Care (A/C) for Chronic Musculoskeletal Pain.
This project will use data collected from a prepaid group practice model health maintenance organization (HMO) that offers A/C coverage for CMP treatment; in this setting, enabling factors of access (insurance coverage, co-pays, lower out-of-pocket costs) will likely mitigate the influence of economic factors [47
]. Consequently, we will be able to explore more fully those non-financial predisposing and need factors that affect A/C decision making. This framework also helps guide us toward the most important domains for measurement.
Finally, there is increased demand for innovative study designs using data from routine practice settings to compare strengths and weaknesses of various medical interventions. Ideal settings are health care systems that use EMRs, provide insurance coverage, and document the use of provider-delivered CAM services, such as A/C care. Innovative research designs in these settings can provide information for health care providers and patients about which CAM and conventional treatments are likely to provide the best clinical, functional, and quality-of-life outcomes for everyday users in routine practice settings [51
]. These designs will include a more diverse range of study subjects than would RCTs and allow longer follow-up, facilitating identification of groups that may uniquely benefit or encounter complications. These settings permit study designs that can examine the full array of treatments and associated outcomes that patients may encounter.
Despite these advantages, making causal inferences in observational studies is more challenging than in RCTs because of confounding by indication. That is, patients (and/or doctors) choose treatments using information that may not be evident to researchers. Patients who receive a given treatment in everyday practice may be dissimilar from their counterparts who do not, in which case treatment outcomes may be at least partially related to unmeasured pre-treatment differences rather than the treatment received. For pre-treatment differences where we have valid information, recent analytic techniques offer the promise of identifying patients with similar probability of receiving a particular treatment [54
]. In the event that one of these patients receives the treatment and the other does not, clinical outcomes may be validly compared for such individuals. Using such approaches can complement what can be achieved with RCTs relatively quickly and efficiently. Such observational studies can highlight important domains for subsequent confirmatory RCTs or point to patterns of utilization and outcomes that are not predicted by existing RCTs.
The aims of the present study are two-fold. The first goal is to examine who (i.e., CMP patients with what characteristics and history of clinical care) will have improved outcomes from A/C care, and to identify the specific characteristics of such care (e.g., duration, comprehensiveness of employed A/C modalities). The second goal is to test an exportable methodological approach that can be used to examine clinically meaningful outcomes for patients: (1) in different settings, (2) using different types of CAM or conventional medical services, with (3) different health care conditions and characteristics.