Richard A. Deyo

Review and analysis of data from two U.S. national surveys in 2002. To examine the prevalence of back pain and physician visits for back pain in the United States. National data on the prevalence of back pain become available only intermittently. We summarized published data from the 2002 National Health Interview Survey (NHIS) on the prevalence of back pain and compared it with earlier surveys. We also analyzed the 2002 National Ambulatory Medical Care Survey (NAMCS) to determine physician visit rates for back pain. In the 2002 NHIS, there were 31,044 adult respondents. Low back pain lasting at least a whole day in the past 3 months was reported by 26.4% of respondents, and neck pain was reported by 13.8%. Among racial groups, American Indians and Alaska Natives had the highest prevalence of low back pain, and Asian Americans had the lowest. Prevalence generally declined with greater levels of education and increasing income. Prevalence estimates were consistent with those from previous surveys, although methodologic differences limited comparisons. NAMCS data suggested that the proportion of all physician visits attributable to low back pain (2.3% in 2002) has changed little since the early 1990s. About one fourth of U.S. adults report low back pain in the past 3 months; the proportion of physician visits attributed to back pain has changed little in the past decade.

Independent of efficacy, information on safety of surgical procedures is essential for informed choices. We seek to develop standardized methodology for describing the safety of spinal operations and apply these methods to study lumbar surgery. We present a conceptual model for evaluating the safety of spine surgery and describe development of tools to measure principal components of this model: (1) specifying outcome by explicit criteria for adverse event definition, mode of ascertainment, cause, severity, or preventability, and (2) quantitatively measuring predictors such as patient factors, comorbidity, severity of degenerative spine disease, and invasiveness of spine surgery. We created operational definitions for 176 adverse occurrences and established multiple mechanisms for reporting them. We developed new methods to quantify the severity of adverse occurrences, degeneration of lumbar spine, and invasiveness of spinal procedures. Using kappa statistics and intra-class correlation coefficients, we assessed agreement for the following: four reviewers independently coding etiology, preventability, and severity for 141 adverse occurrences, two observers coding lumbar spine degenerative changes in 10 selected cases, and two researchers coding invasiveness of surgery for 50 initial cases. During the first six months of prospective surveillance, rigorous daily medical record reviews identified 92.6% of the adverse occurrences we recorded, and voluntary reports by providers identified 38.5% (surgeons reported 18.3%, inpatient rounding team reported 23.1%, and conferences discussed 6.1%). Trained observers had fair agreement in classifying etiology of 141 adverse occurrences into 18 categories (kappa = 0.35), but agreement was substantial (kappa ≥ 0.61) for 4 specific categories: technical error, failure in communication, systems failure, and no error. Preventability assessment had moderate agreement (mean weighted kappa = 0.44). Adverse occurrence severity rating had fair agreement (mean weighted kappa = 0.33) when using a scale based on the JCAHO Sentinel Event Policy, but agreement was substantial for severity ratings on a new 11-point numerical severity scale (ICC = 0.74). There was excellent inter-rater agreement for a lumbar degenerative disease severity score (ICC = 0.98) and an index of surgery invasiveness (ICC = 0.99). Composite measures of disease severity and surgery invasiveness may allow development of risk-adjusted predictive models for adverse events in spine surgery. Standard measures of adverse events and risk adjustment may also facilitate post-marketing surveillance of spinal devices, effectiveness research, and quality improvement.

Examining trends and geographic variations in clinical care offers insights into changes in clinical decision making. We summarized data on spine surgical rates, trends, and variations in the United States to highlight areas of professional uncertainty and questions for future research. The United States has the highest rate of spine surgery in the world, but spine surgery shows wider geographic variations than most other procedures. For example, Medicare data for 2001 showed sixfold variations in spine surgery rates among United States cities, and 10-fold variations in spine fusion rates. United States spine surgery rates rose 55% in the 1980s. In the 1990s, studies of surgical rates became more difficult because 20% of discectomies shifted to an out-patient setting. Extrapolations from states with ambulatory surgery data suggest overall lumbar surgery rates continued to rise throughout the 1990s. The most rapid increase was for spinal fusion, which tripled during the 1990s and accounted for an increasing proportion of all spine procedures. Some increases coincided with the introduction of new surgical implants. Despite new technologies, rates of repeat surgery after fusion were no lower than the rates after decompression alone. As new technology for spine surgery is introduced at an accelerating pace, we anticipate substantial changes in surgery patterns. Analysis of population-based data may be useful for surveillance of changes and their impacts.

Despite the growing popularity of therapeutic massage in the US, little is known about the training or practice characteristics of massage therapists. The objective of this study was to describe these characteristics. As part of a study of random samples of complementary and alternative medicine (CAM) practitioners, we interviewed 226 massage therapists licensed in Connecticut and Washington state by telephone in 1998 and 1999 (85% of those contacted) and then asked a sample of them to record information on 20 consecutive visits to their practices (total of 2005 consecutive visits). Most massage therapists were women (85%), white (95%), and had completed some continuing education training (79% in Connecticut and 52% in Washington). They treated a limited number of conditions, most commonly musculoskeletal (59% and 63%) (especially back, neck, and shoulder problems), wellness care (20% and 19%), and psychological complaints (9% and 6%) (especially anxiety and depression). Practitioners commonly used one or more assessment techniques (67% and 74%) and gave a massage emphasizing Swedish (81% and 77%), deep tissue (63% and 65%), and trigger/pressure point techniques (52% and 46%). Self-care recommendations, including increasing water intake, body awareness, and specific forms of movement, were made as part of more than 80% of visits. Although most patients self-referred to massage, more than one-quarter were receiving concomitant care for the same problem from a physician. Massage therapists rarely communicated with these physicians. This study provides new information about licensed massage therapists that should be useful to physicians and other healthcare providers interested in learning about massage therapy in order to advise their patients about this popular CAM therapy.

Retrospective cohort study using national sample administrative data. To determine if lumbar fusion rates increased in the 1990s and to compare lumbar fusion rates with those of other major musculoskeletal procedures. Previous studies found that lumbar fusion rates rose more rapidly during the 1980s than did other types of lumbar surgery. We used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample from 1988 through 2001 to examine trends. U.S. Census data were used for calculating age and sex-adjusted population-based rates. We excluded patients with vertebral fractures, cancer, or infection. In 2001, over 122,000 lumbar fusions were performed nationwide for degenerative conditions. This represented a 220% increase from 1990 in fusions per 100,000. The increase accelerated after 1996, when fusion cages were approved. From 1996 to 2001, the number of lumbar fusions increased 113%, compared with 13 to 15% for hip replacement and knee arthroplasty. Rates of lumbar fusion rose most rapidly among patients aged 60 and above. The proportion of lumbar operations involving a fusion increased for all diagnoses. Lumbar fusion rates rose even more rapidly in the 90s than in the 80s. The most rapid increases followed the approval of new surgical implants and were much greater than increases in other major orthopedic procedures. The most rapid increases in fusion rates were among adults aged 60 and above. These increases were not associated with reports of clarified indications or improved efficacy, suggesting a need for better data on the efficacy of various fusion techniques for various indications.

Background: The diagnosis of discogenic back pain often leads to spinal fusion surgery and may partly explain the recent rapid increase in lumbar fusion operations in the United States. Little is known about how patients undergoing lumbar fusion compare in preoperative physical and psychological function to patients who have degenerative discs, but receive only non-surgical care. Methods: Our group is implementing a multi-center prospective cohort study to compare patients with presumed discogenic pain who undergo lumbar fusion with those who have non-surgical care. We identify patients with predominant low back pain lasting at least six months, one or two-level disc degeneration confirmed by imaging, and a normal neurological exam. Patients are classified as surgical or non-surgical based on the treatment they receive during the six months following study enrollment. Results: Three hundred patients discogenic low back pain will be followed in a prospective cohort study for two years. The primary outcome measure is the Modified Roland-Morris Disability Questionnaire at 24-months. We also evaluate several other dimensions of outcome, including pain, functional status, psychological distress, general well-being, and role disability. Conclusion: The primary aim of this prospective cohort study is to better define the outcomes of lumbar fusion for discogenic back pain as it is practiced in the United States. We additionally aim to identify characteristics that result in better patient selection for surgery. Potential predictors include demographics, work and disability compensation status, initial symptom severity and duration, imaging results, functional status, and psychological distress.

Background: Despite the growing use of complementary and alternative medicine (CAM) by consumers in the U.S., little is known about the practice of CAM providers. The objective of this study was to describe and compare the practice patterns of naturopathic physicians in Washington State and Connecticut. Methods: Telephone interviews were conducted with state-wide random samples of licensed naturopathic physicians and data were collected on consecutive patient visits in 1998 and 1999. The main outcome measures were: Sociodemographic, training and practice characteristics of naturopathic physicians; and demographics, reasons for visit, types of treatments, payment source and visit duration for patients. Result: One hundred and seventy practitioners were interviewed and 99 recorded data on a total of 1817 patient visits. Naturopathic physicians in Washington and Connecticut had similar demographic and practice characteristics. Both the practitioners and their patients were primarily White and female. Almost 75% of all naturopathic visits were for chronic complaints, most frequently fatigue, headache, and back symptoms. Complete blood counts, serum chemistries, lipids panels and stool analyses were ordered for 4% to 10% of visits. All other diagnostic tests were ordered less frequently. The most commonly prescribed naturopathic therapeutics were: botanical medicines (51% of visits in Connecticut, 43% in Washington), vitamins (41% and 43%), minerals (35% and 39%), homeopathy (29% and 19%) and allergy treatments (11% and 13%). The mean visit length was about 40 minutes. Approximately half the visits were paid directly by the patient. Conclusion: This study provides information that will help other health care providers, patients and policy makers better understand the nature of naturopathic care.

Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in “burn-out” among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA’s advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.