Reliable Back Issue To Economic Opportunities
Stanley J. Bigos, MD, Prof Emeritus Orthopedic Surgery & Environmental Health, UW Seattle, WA
Abstract
The financial
emphasis in medicine, that confuses and frustrates clinicians, is at least in
part due to costly back issues. Costs
triggered a 1990’s reliable information search to curb the back’s
ill effects in clinical care, work absenteeism, disability, and medical legal
issues. The subsequent validation of
this reliable data combined the
Introduction
Back problems impact numerous
financial issues in our society. The back
is an expensive health care issue, the most expensive industrial injury claim
and the most common cause of disability under age 45 years, second only
to cardiovascular disease worldwide.[1],[2] Back issues impact the cost of worker’s
compensation, general health costs, and in recent years have provoked expensive
legal battles to regulate the economic impact on individuals and their
employers. The employer’s burden
then affects all sectors of society whether as patients, citizens, taxpayers
or consumers. A weakened economy
exposes unnecessary burdens and frailties of hypothesis driven
decisions. Triggered by back
controversies, the past decade’s medical and legal efforts to define reliable
information offer legislators a competitive advantage in creating a better
economic climate by using a firmer foundation upon which to make legal
and legislative decisions. Thus,
economic downturns actually set the stage for competing economies (such as
within the
Layoffs and reduced revenues empty
state coffers, sparking discussions of balancing economic stimulus
packages with cuts in services.
Not until governments teeter under the financial burden of an economic
downturn do state officials have to face how certain legislative and
administrative decisions discourage and frustrate employers. As an example, the negative impacts of prior
legislative decisions seem to be impacting multiple areas in
The present economic downturn may seem like “the worst of times,” but the remedial advances of the past decade proffer an opportunity for any state struggling to both reduce costs and stimulate their economy to capture a major economic advantage. The lure of good paying jobs into a jurisdiction is fostered by a stable economic climate for employers. A stable economic climate means employers are no longer frustrated by arbitrary, hypothesis based regulation, insurance and medical decisions that make the estimate of production costs impossible. The frustration only deepens when legislative interpretations based on “conventional wisdom,” fly in the face of reliable information as defined by the Federal Rules of Evidence since the 1993 Daubert v. Merrill Dow Supreme Court Decision. Is it unreasonable for employers, as well as, citizens to ask why theories, hypotheses or conventional wisdom are allowed to be the basis for expensive ergonomic rules and guidelines or disabling elective treatment decisions when the Federal Rules of Evidence (F.R.E.) would not allow their premise as evidence in a simple product liability tort case? Employers are the key to making economic prosperity a reality for jurisdictions. Thus, any state seeking employers with high paying jobs, in a time of economic woes, has an opportunity to invest in its fiscal future by limiting frustrating arbitrary decisions. Adopting F.R.E. definitions of reliable data to guide health and regulation decisions will definitely get the attention of employers seeking a stable economic climate. The F.R.E. also provide an avenue of professionalism and safety to patients and clinicians alike, while reducing costs to tax paying citizens. It seems the controversies in back-care initiated a segue to such an opportunity.
The 1990’s
Define Reliable Data
US Federal
Government’s Agency for Health Care Policy and Research (AHCPR) was mandated
to seek a more reliable guide to care for back problems.[8] They selected a panel of 23 national
experts with 7 international consultants in 1992. The panel represented 19 disciplines were
selected to advise their constituents about the reliable information concerning
back problems. Convinced against trying
to be “pain busters,” the panel of experts chose a more measurable
element of back symptoms – the resultant reduced activity tolerance. Rather than attempting a “back pain guide”
they created a “back problem guide” for treating a measurable and essential
issue - reduced activity tolerance due to back pain and/or back related
leg symptoms. Accepting the presence of
diverse views of the written literature, panel members chose an evidence
table based methodological process to determine the reliability of the
published literature. The methodological
process evaluated over 11,000 abstracts yielding over 4600 articles to
be screened for the US Department of Health and Human Services published
Guideline No. 14 on
Seven years later, a 2001 evaluation of the literature following the AHCPR Guide (No. 14 - Acute Low Back Problems in Adults), recommended only minor additions.[9] Newer data strengthened the vast majority of the original “finding and recommendation” statements. Other reviews including the Cochrane Collaboration (more of a medical than activity model) have furthered interest in evidence-based care with a similar literature review process.[10] Most significantly, this emphasis on reliable data became more than just academic as issues about reliable science provoked a historic change in the Federal Rules of Evidence (F.R.E.).
In response to
the proliferation of product liability suits, the United States Supreme Court,
in 1993, sought a mechanism to sort out the confusion caused by what
Huber termed “junk science” (courtroom pseudo-science).[11] The landmark U.S. Supreme Court’s
The reliable data approach slowly creeps into
individual state worker’s compensation arenas.
In 2000, attorneys reminded everyone that the Daubert Rules of Evidence
were interesting but not a part of worker’s compensation. In February of 2001,
2000-2010
Bone and Joint Decade – Disability of the Back
In January of
2000, the World Health Organization (WHO) invited over 450 worldwide
delegates to
Dr. Lopez addressed unsubstantiated prevention approaches apprising delegates of flawed reports based on a coupling of misplaced advocacy with epidemiology.26 He demonstrated how advocacy-driven epidemiology easily over estimated problems. To make his point, he demonstrated how enthusiastic recording and reporting can even overestimate an outcome as objective as death. Dr. Lopez cautioned how much greater is the tendency with less objective intake and outcome criteria as for back pain and other “musculoskeletal disorders.” Later that same year, the National Academy of Science (NAS) MSD Report for OSHA 2000 echoed Dr. Lopez’ concerns about objective criteria.[27] After reviewing the literature that defines OSHA’s use of the term Musculo-Skeletal Disorder (MSD), NAS committee could define an MSD no more objectively than “a loss of the sense of well-being.”
Dr. Lopez’ also estimated monopolar depression, now the 4th leading cause of disability worldwide, will become number two by 2010 with proper reporting. Most astute clinicians realize musculoskeletal complaints to be a common presentation for monopolar depression.[28] In summary, Dr. Lopez called for more realistic assessment and analysis of patients presenting with symptoms in the workplace. Taking heed, Julie Agel, Ph.D., U. Minnesota, formalized a suggestion of the meeting’s Trauma section to strengthening the quality of recorded data. Her committee insisted, “We must exclude sprains & strains without evidence of damage from the trauma registry as they are not objective, usually fleeting and an etiological dilemma.” When asked, the 450 attending delegates agreed that symptoms devoid of objective findings should neither be recorded as arthritis nor recorded as an injury without objective evidence of damage. By January of 2000, the worldwide experts no longer wanted to be mislead by loose criteria or soft data. They demanded more structured approaches to gather and interpret information needed to guide care, prevention and research efforts.
Reliable
Data and Regulations
Few issues in
the
The initial work attempted to link lifting exposures to joint degeneration. Then subjective complaints at work furthered the conjecture about the relationship of impairment (damage) to disability. Gradually, without scientific support to justify the claim, mechanical exposures were accused of causing a less specific problem, termed musculoskeletal disorders.[31] While sounding ominous and encompassing, the scientific foundation for MSDs is feeble. OSHA then convened the National Academy of Science committee who fashioned the scientific definition of MSD no more specific than their now famous “loss of the sense of well being”.[32]
Most of the confusion about work causing damage to joints relates to the finding of spinal aging changes that are commonly termed degeneration. In the lumbar spine, these degenerative findings increase with age.[33],[34] The variation in expression of these aging changes induced some to espouse that they were caused by exposure to activity, vibration, heavy work or postures.[35]
Onset of symptoms and spinal loading exposures do parallel that of spinal aging, which is commonly termed “degeneration.” If these spinal changes parallel symptoms and tolerance – what causes these “degenerative” changes? Different scientific groups have evaluated identical twins according to many discordant issues.[36], [37], [38], [39], [40], [41], [42], [43] Battié and Videman have studied discordance for heavy physical loading and material handling to include lifting, bending, twisting, prolonged sitting, sustained neutral work postures and the vibration of vehicular driving in monozygotic twins. .[44], [45], [46], [47],[48] The most generous conclusion is that the above factors appear to be “particularly modest” when compared with familial influences. Due to the stir created by these vibration findings[49], a third cohort was added in a fashion similar to most disagreeing studies. This third cohort composed of rally car drivers who experienced extremes of vibration yet displayed no more spinal changes than did the twin groups.[50] The gestalt of this research indicates that short of fracture or dislocation, the blame for the findings on our spine imaging studies falls on our parents. The identical twin studies further question medical relationships of these apparent aging changes in the disc as did Holt’s study in the late 1960s looking at discogram’s ability to determine pain producers.[51] Carragee et al., from 1999-2002, further exposed the latter hypothesis’ lack of reliability in discography and high intensity zone studies. His group found discography unable to differentiate mild from disabling back pain or back pain from non-spine symptoms.[52],[53],[54],[55] They also determined provocative discography, in patients with chronic symptoms or psychological problems, to not only lack reliability but generate significant back pain for over a year in individuals with no prior back problems.[56] The monozygotic discordance studies support Holt’s anatomic and Carragee’s concordance findings, and further hampers attempts to attribute subsequent joint changes to working without immediate evidence of damage due to specific trauma. [57], [58], [59], [60], [61], [62], [63], [64]
NIOSH Lifting Equation or Activity Paradigm ?
NIOSH Lifting Equation
The interest in reliable data has now seeped into the regulation arena. In the mid- 1990’s, after 30 years of effort, NIOSH and OSHA first attempted to establish an ergonomic standard to regulate the workplace by using the indirect epidemiological methodology, as was successful with the objective diagnostic criteria for arsenic poisoning, asbestosis and smoking.[65]
NIOSH first
attempted a lifting guide in 1981. The ergonomically oriented committee sought
mechanical data as the basis for a lifting equation. From the available ergonomic data, the
committee chose conservative safe limits as an “Action Level” at 3400
Figure
NIOSH Lift Equation A (modified from Chaffin and Andersson 1984)
Chaffin and
The Revised NIOSH Lifting Equation’s published forward echoed the committees call for the validation of the lifting equation.[74] Waters, et al, 1999 attempt to validate the lifting equation as depicted in 1991 but fell short (Table NIOSH Lifting B). Waters et al, found the risk of back injury claims with increasing lifting loads at or above a Lifting Index of 3 (lifting 102 pounds or more) was not increased compared to the barely significant increase in risk at Lifting Index of between 2-3 (no lifting risk was found lifting #51 at Lifting Index of 1pounds).[75] Another preliminary report also struggled with validation.[76] In essence, should lifting be arsenic, a little may make you ill or even kill you but if you triple the dose - no problem! This flies in the face of reasonable criteria for causality like the 1979 NIOSH or Bradford Hill criteria.[77],[78]
Figure NIOSH Lift Equation B
(modified from Chaffin and
# - pounds, Lifting index =amount lifted/recommended
Weight Limit, Lift Index of 1 = Recommended Weight Limit (~51# ideal lift),
Lift Index x 2 = (~102# ideal lift), Lift Index x 3 = (~153# ideal lift), Stat.Signif. – Statistically Significant difference. [Note
the same 3400 and 6400
In 1997 NIOSH published a review of the literature known as the “yellow book”.[79] The lack of adherence by the NIOSH experts to current methodological standards, such as those used by the AHCPR Low Back Guideline Panel, provoked a very heated debate about their conclusions.[80] OSHA’s October of 2000 regulation attempt, based upon the NIOSH 1997 yellow book, was eventually voted down in 2001.[81] Hearings in the US House of Representatives, US Department of Labor and the US Senate argued the potential benefits of the regulation were not substantiated and the costs were substantial.[82],[83],[84] Neither the failed 2000 rule nor the subsequent April of 2002 guideline that it sired, provided specific recommendations but still demanded solutions.[85],[86] For instance, should a job have two MSD claims within one year, the regulation could demand that there be no more than two 10 lbs. lifts per minute and for no more than 2 hours per day. Of interest, OSHA still plans to evaluate and fine the “evil-doer” employers they deem “bad actors” according to the yet to be validated lifting equation. [87]
Prospective trials by Daltroy et al., and Yassi et al., did not support the OSHA stance or the premise for the lifting guide. [88],[89] Both trials stepped beyond drawing correlations after creating a hypothesis to actually studying the hypothesis to see if it is true or not true. Daltroy et al., in 1997, attempted to teach proper lifting mechanics to reduce back problems in postal workers but their five-year trial yielded no change in number or cost of claims in the study group.[90] The randomized trial published in 2001, by Yassi et al, compared a group of hospital workers who avoided all strenuous lifts, compared to a group educated in proper lifting and use of available lifting devices and a third control group without any intervention who were allowed to participate in normal patient lifting activities.[91] Similar findings in prospective intervention trials by Smedley et al, 2003 and Harkness et al, 2003 recent data now echo Yassi et al, 2001 indicating that neither the elimination of strenuous lifting nor the biomechanical lifting education significantly reduces lifting claims or complaints. Another soon to be published article evaluated 6 identical package delivery hubs with a 610% difference in injury claim rates, but found that “no demographics or workplace measures predicted hub injury incidence, nor accounted for the lack of validity in NIOSH Work Practice Guide for Manual lifting predictions.”[92] These prospective studies beg the basic question about simple mechanical prevention. When one looks at the data upon which the original NIOSH lifting committee based their lifting equation, we are not surprised at the subsequent results or difficulty with prevention.
Studies find a report of back injury at work is a complicated combination of physical and non-physical factors.[93],[94],[95] Conventional attempts to prevent the back limitations, that affect virtually all of us by age 50, through avoiding activity have failed. One prospective trial by Gundewall et al. had a positive impact on prevention.[96] This result supports clinical use of conditioning for endurance of the erector spinae spine muscles to reduce the frequency and severity of recurrences.
Ergonomics has proven value for making the workplace more productive and a better place for individuals. The data indicates that for preventing disability with biomechanics, the emphasis may be too little bio- and too much mechanics. While generating a hopeful hypothesis, scientific studies seem condemned emphasizing mechanics alone.” Albert Einstein probably said it best, “Make things as simple as possible – but not simpler.”
“Conventional wisdom” attempted to relate back damage to physical work, in the hopes of making back problems preventable. The failures to tie specific work activities to joint damage changed the focus to “complaints” alone of which back problems are the most common. Yet, no intervention study that isolates mechanical factors from the bias of discordant attention has been proven to effectively prevent back problems at work. The well-controlled prospective intervention studies further erode the concept and expose the misleading potential of hypothesis generating studies.[97],[98],[99],[100],[101]
“Harmless” Hypothetical Terms
Some may argue that despite the lack of reasonable data, “what is the harm in embracing hypotheses?”[102],[103],[104] Unfounded theories and hypotheses have had grave impact on patients and society alike throughout history. Did medicine not support bleeding for infection, mercury to treat depression, arsenic for infection, killing dogs and cats to control the bubonic plague? All were well intentioned, some close but off the mark with later proven significant perils. Even today, we have ample evidence that theories alone can easily become ingrained as a part of many teaching programs as evinced by a common and revealing hypothesis. We have reviewed vibration. We can also look at hysterectomy, the Adkins diet or hormonal replacement! How else could one explain the following clinical description that strikes at the heart of the matter.
“Her doctor said she cannot lift more than 20
pounds, repeatedly flex her wrists and elbows or keep her arms extended at shoulder
height for long periods.”
“… she was diagnosed with bilateral carpal tunnel syndrome
and bilateral tendinitis. … personal physician who placed her on permanent
work restrictions that precluded her from lifting more than 20
pounds or from “frequently lifting or carrying of objects weighing up to
10 pounds,” engaging in “constant repetitive … flexion or extension of
[her] wrists or elbows,” performing “overhead work,” or using “vibratory
or pneumatic tools”
One could take umbrage with the above, for being based on clinical complaints alone. The following quotes seem to move toward the rarified air of the hypothetical. Could these terms have a detrimental impact on the patient’s perception of being ill?
“… again sought care … diagnosed
with myotendinitis bilateral periscapular, an inflammation of the
muscles and tendons around both of her shoulder blades; myotendinitis and myositis
bilateral forearms with nerve compression causing median nerve
irritation; and thoracic outlet compression, a condition that causes
pain in the nerves that lead to the upper extremities” (all clinical
diagnoses)
Finally, medical recommendations set the stage for a lawsuit.
“last day (she) worked at ... plant, she was placed under a no-work-of-any-kind
restriction by her treating physicians.”
Such hypothesis
laden pseudo-scientific falderal probably had a significant impact both
on Ms. Williams losing her job and her understanding of fault. How would one apply the reliable
literature to these quotes?
Would not such quotes be found quite interesting by the WHO,
AHCPR Panel #14, Cochrane Collaboration or
Opportunity for Sagging
Economies
Reliable information, resulting from both medical and legal advances, now offers some hope to any jurisdiction that wants to be more economically competitive. Using the legal precedence for reliable information should not only improve the care for injured workers but also make health care more affordable for its residents. The incentive to legislators to make it happen will be the interest in hearing the “economic sucking sound” Ross Perot described in the NAFTA debates of employers bringing high paying jobs into their state.
The Daubert Federal Rules of
Evidence hold a major key for a state to
attract employers with higher paying jobs away from its neighbors for
several reasons. First, health
related regulations would no longer be a political effort based upon
hypothesis generating papers, because those papers would not be
allowed in a simple product liability tort case. Instead the court would require reliable
data to guide efforts. Regulation
processes would no longer be the product of political lobbying dominated by
“Validation by Hanky” (as termed by Thomas Bohr, MD at
Second, reliable information should help decision makers identify disabling procedures presently based upon conventional wisdom and hypotheses. Reliable data can allow health care to be better defined. Health care may then be able to differentiate diagnoses from “a loss of the sense of well being” issues and further differentiate care required for health from recommendations needed “feel good” issues. Then planners could better estimate surgical rates and ultimately, total costs for health care. Worldwide we can accurately estimate how many hip fractures will require surgery by knowing the demographics of the population. But for common life experiences like back pain, the lumbar surgery rates differ 9 fold in different parts of the country and as much as 10 fold within the Washington state.1 Reliable information is available to define acute, life – death issues, and terminal-care while providing adequate proven methods for symptoms of a loss of “ a sense of well being.” Alone, this definition of health care will enhance both patient understanding and decision making, while promoting professionalism and reducing the hassles for clinicians.
Third, research would remain research through funding agencies rather than being marketed as the latest medical breakthrough demanded by unknowing hopeful patients. Providers of “feel good” care could then be given the unfettered advantage that plastic surgeons have enjoyed for years or differential premiums can be chosen by those who actually purchase their own policies. Feel good wares could be sold fee for service with the added money available to prospective patients from improved wages and reduced taxes and insurance premiums. Optimally, once reliable data has differentiated elective care from elective “feel good” issues, insurance premiums could then be tiered to reflect an individual’s interest in the availability of “feel good” provisions. Doubtlessly, reversal of other potential Frye rule’s injustices, based upon “junk science,” will lead to further state trimming to the benefit of a citizen’s take home pay and make the state more attractive to employers with good paying jobs. After all, what is wrong with an elective decision being based upon science rather than a mysterious process? Why should citizens be disabled unnecessarily by marketing and medical decision based on “junk science”? It seems inevitable that the Federal Rules of Evidence will be accepted in all jurisdictions. It follows then, that the greatest economic advantage goes to the state that first adopts Daubert F.R.E. in a particular region.
Reliable information can unlimber medical professionalism by providing clinicians with legal protection and guidance in providing recommendations for patients seeking advice about elective medical issues. Since Abraham Flexner’s 1910 report on medical school education, medicine has struggled to move away from a “mysterious process” toward a scientific foundation.[108] The American Academy of Family Practice seems to be on the verge of taking steps to become the first truly professional medical organization. Clinicians perhaps have tired of sifting through the banquet of specialty groups who publish marketing drivel about elective medicine. They recently suggested Continuing Medical Education credits to be based only upon reliable information such as from the Cochrane Collaboration and AHCPR.[109] Such bravery will be an important step toward confirming society’s belief that medical decisions are based on science.
Summary
Economic pressures brought clinicians Diagnosis Relate Groups (DRGs), managed care, discounted fees and fostered an increased reliance upon technology. Unfortunately, the resultant fettered professionalism has fostered some activities of societal concerns. In the fall of 2002, headlines included sanctions against a neurosurgeon in Waco, Texas for being too surgically aggressive, as well as, the report of FBI agents raiding a hospital and doctors’ offices in Redding, CA seeking information about unnecessary surgery.[110],[111]
While economic pressures can be seen as the culprit, these same insidious pressures may well be the force that drives both medicine and law toward reliable information. Over the past decade, efforts to determine reliable information have set the stage to improve medical professionalism and expand the legal protection for clinicians who embrace reliable information in their practice. With economic downturns, reliable information provides an opportunity for states to financially right themselves by offering frustrated employers reliable decision-making that also protects clinicians, patients and employees giving each an incentive to be contributors to society. Indeed, the economic pressures have jaundiced medicine in the eye of the general public, but may well be the force that moves a bellwether state government to eclipse our present dilemma by adopting the Daubert Federal Rules of Evidence as a guide. Reliable information for worker’s compensation decisions, regulations, may even provide a definition of health care as a first step to being affordable to more citizens and avoiding federalization.
James Madison once said, “Knowledge will forever govern ignorance: And a people … must arm themselves with the power which knowledge gives.” Should one state realize the financial advantage of reliable information, the “economic sucking sound” of frustrated employers moving their high paying jobs to a reliable jurisdiction, will force adjacent states to follow suit in order to thwart an economic disaster. Thus, the opportunity lies in the hands of the first forward-looking legislators to realize that the Federal Rules of Evidence are inevitable and recognize the economic advantages associated with embracing reliable information sooner rather than later.
The advantage is all about the tools set in place over the past decade founded on the definition of reliable information that can allow a state to prosper, the clinician to be a well paid professional and the consumer to have a greater opportunities for better paying jobs, fewer taxes, lower costs of goods and better services. Just as controversies pushed the science about back problems and other health care issues, economic pressures now provide an opportunity for change to a more reliable system. In a more reliable system, patients will need not be disabled by politically driven “junk science” or mutilated by invasive medical dreck. Reliable information helps the consumer of professional services and lessens the threat to livelihood and future when back and other aches and pains surface. More importantly, a stronger more reliable economy gives a greater portion of our society “something better to do than hurt.”
References