Bone and Joint Clinic of Houston

Outcomes from Arthroscopic Rotator Cuff Repair: Dependent Upon Age and Tear Size

noemail@bjc-houston.com — Thu, 18 Sep 2008 15:00:00 GMT

Outcomes from Arthroscopic Rotator Cuff Repair: Dependent Upon Age and Tear Size

Success rate from arthroscopic rotator cuff repair depends on what is being measured. Patient satisfaction is the most common reported outcome from arthroscopic rotator cuff repair. Patient satisfaction is measured with standardized tests based upon patient responses to questions regarding their pain levels following surgery and their ability to carry out daily household, work, and sporting activities. Additional data is derived from physician measures of shoulder motion and rotator cuff strength.

Patient satisfaction is rated excellent and good for 93 to 97% of patients after arthroscopic rotator cuff repair in recent studies from Flurin et al in Arthroscopy 2007, Burns and Snyder in Journal of Shoulder and Elbow Surgery (JSES) 2008, and Charosset et al in American Journal of Sports Medicine (AJSM) 2007.

Success measures of patient satisfaction after rotator cuff repair depend upon age. Looking specifically at patients over 62 years of age, 87% had good to excellent results in a study by Grondel and Savoie in JSES 2004. Whereas, 100% of patients less than 40 years old had pain relief and 95% had improved function after arthroscopic single row repair in Krishnan Arthroscopy 2008.

While improvements of pain and return of function are clearly important to both patients and surgeons, healing of the arthroscopically repaired rotator cuff tendon may be a better measure of a successful outcome of the planned surgical anatomic goal. On closer inspection of the data, patients with an intact, healed rotator cuff repair had higher scores than those with a recurrent tear in the Flurin study. That study reported a 15% retear rate. Sugaya in Arthroscopy 2005 reported a retear rate of 25% for patients repaired with a single row of anchors, but that rate was lowered to 10% for those patients who had a dual row arthroscopic rotator cuff repair. Dual row arthroscopic repair uses two sets of anchors and does increase the area with which the rotator cuff has to heal. Lafosse in JBJS 2007 reported a 0% retear rate for small and medium sized tears after arthroscopic dual row rotator cuff repair.

Rotator cuff tears are described as small or medium if they are less than 3 centimeters, about 1 inch. Sugaya in Journal of Bone and Joint Surgery (JBJS) 2007 reported a 5% retear rate for small and medium sized tears. Gladstone in AJSM 2007 reported a 39% retear rate, and stated that size of the tear was the only single variable that predicted retear.

Rotator cuff tears are described as large or massive when they are larger than 3 to 5 centimeters or involve 2 or more of the 4 rotator cuff tendons. Outcomes of arthroscopic repair of large and massive tears are less successful than repair of small and medium rotator cuff tears, but nonoperative treatments have even lower success rates in patients who desire to regain or retain function in Zingg JBJS 2007. Galatz in JBJS 2004 reported good functional results and patient satisfaction despite a 94% retear rate based upon ultrasound for patients with massive rotator cuff repair. Based upon MRI and CT arthrogram, Sugaya reported a 40% retear rate for large and massive tears, and Lafosse reports only a 17% retear rate for large and massive rotator cuff tears that underwent arthroscopic dual row repair.

Investigational techniques to reduce the retear rates for arthroscopic rotator cuff repair of large and massive tears have been reported. Park in AJSM 2008 reported improved results in patients with large and massive cuff tears with a dual row arthroscopic repair. Burkhead in Seminars in Arthroplasty 2007 reported on 17 patients with massive tears greater than 5 centimeters that underwent open rotator cuff repair with allograft patch augmentation of the repair with a 25% retear rate. Snyder and Bond in International Journal of Shoulder Surgery 2007 describe a technique of allograft patch rotator cuff replacement for irreparable rotator cuff tears measuring greater than 5 centimeters and report only 3 recurrent defects in 16 patients. Doctors Taylor Brown and Marc Labbe are currently using arthroscopic dual row rotator cuff repair as well as arthroscopic allograft augmentation and replacement to help improve the outcomes and success rates for their patients at the Bone and Joint Clinic of Houston. Please contact the clinic to determine if you may benefit from arthroscopic rotator cuff repair as well as one of these new techniques.

18-Sep-08 10:00 AM

Zimmer’s “Durom” Hip Resurfacing Devices

noemail@bjc-houston.com — Thu, 24 Jul 2008 15:00:00 GMT

Zimmer’s “Durom” Hip Resurfacing Devices referenced in Barry Meier’s article in The New York Times, July 24^th “Complaints Undermine Hip Device” HAVE NEVER BEEN USED by any of our surgeons at Bone & Joint Clinic of Houston. Your Zimmer hip device used by Bone & Joint Clinic of Houston IS NOT the one referenced in the article. The article’s photo does not show the actual Zimmer “Durom” implants. The actual picture can be found at: Zimmer Durom

http://www.zimmer.co.uk/z/ctl/op/global/action/1/id/9226/template/MP

24-Jul-08 10:00 AM

New Hammertoe Headless Compression Screw for Fusion

Sun, 10 Feb 2008 20:00:00 GMT

Arthrodesis of the PIP Joint Using a Headless Intramedullary Screw

William Granberry M.D.

Presented at: 2007 AOFAS Annual Summer Meeting Toronto Canada

Introduction: Standard fixation for arthrodesis of the PIPJ in hammertoe surgery has been a smooth k-wire. Reliable arthrodesis is difficult using a smooth wire alone. Nonunion and malunion rates vary from 20% to 60%. Dissatisfaction with surgery is primarily related to nonunion and malunion. This report describes an intramedullary fixation technique that provides reliable maintenance of alignment and ultimate fusion of the PIPJ. This study explores the viability of more permanent fixation to ensure alignment and a higher fusion rate to improve patient satisfaction.

Conclusions: Intramedullary fixation of the PIPJ using a headless self-compression screw provides reliable radiographic and subjective results when used for hammertoe reconstruction. Refinement in techniques and screw design will make fixation of the PIPJ even more simple and reliable.

Methods: A consecutive series of 19 patients who had hammertoe surgery from July 2004 through December 2005 using intramedullary fixation of the PIPJ were included in this study. All patients had resection of the distal end of the proximal phalanx and removal of the articular cartilage from the middle phalanx. A headless self-compression screw was then used to fixate and compress the joint. The screw was placed retrograde using a specially designed screwdriver. It was inserted past the distal phalanx and DIPJ to immobilize only the PIPJ. Additional procedures were done in each patient as determined by the deformities present. Postoperative management allowed for immediate weight bearing and the use of a hammertoe splint to prevent MTP extension for 6 weeks. Follow up examination included clinical and radiographic exam.

Results: A total of 19 patients (32 toes) were available for review. The average age was 62 years (range 58 to 72). Average follow up was 11 months (minimum 6 months). There were 22 second toes, 6 third toes and 4 fourth toes. Preoperatively, patients complained primarily of pain, callusing and difficulty with shoes. Additional surgery was performed on 18 feet. There were 6 bunionectomies, one MTP fusion, 2 plantar condyectomies and 9 Weil metatarsal shortening osteotomies. There were no acute postoperative complications. All but one of the toes were solidly fused by 3 months. Alignment improved in all of the cases. Preoperative flexion of the PIPJ averaged 53.5 degrees (range 20 to 115 degrees). Postoperatively the average alignment was 3 degrees of flexion (range 0 to 18 degrees). The average correction was 50 degrees (range 20 to 115 degrees). Axial alignment improved as well. The deviation in the AP plane ranged from 45 degrees of varus to 68 degrees of valgus. Postoperatively only one toe was more than 10 degrees (28 degrees of valgus) from straight. MTP hyperextension averaged 23 degrees (range 10 to 48 degrees) and improved in all the toes as well. One patient had frank dislocation of the MTP preoperatively. Only 4 toes had 20 degrees or more of residual MTP extension. All patients were satisfied with the postoperative result. The appearance of hyperextension of the PIPJ was noted in 4 patients, however they remained satisfied and no additional surgery was required.

10-Feb-08 2:00 PM

Arthroscopic rotator cuff repair useful in treatment for recurrent traumatic shoulder instability

noemail@bjc-houston.com — Thu, 07 Feb 2008 03:00:00 GMT

Shoulder dislocations are common at every age in adult life. In persons under 30, recurrent instability is likely the result of ligament and cartilage damage. However, in patients over the age of 40 years, recurrent instability is more than likely the result of a rotator cuff tear at the time of their shoulder dislocation.

These rotator cuff tears can be repaired arthroscopically to return shoulder stability. Initial treatment for a shoulder dislocation is emergent closed reduction with sedation. Following reduction of the dislocation, some people have persistent instability which may be manifested by persistent pain or uneasiness with the shoulder an overhead position. Alternatively, some people’s shoulder may continue to dislocate out of socket even despite immobilization in a brace.

Doctors Taylor Brown and Marc Labbe at the Bone and Joint Clinic of Houston have had great success with arthroscopic rotator cuff repair following traumatic glenohumeral joint dislocations that are associated with persistent instability. The two fellowship trained orthopedic sports medicine physicians are currently collecting their follow-up data in their prospective study on this complex subject. Early results demonstrate excellent return of motion and strength with no recurrent instability.

Standard arthroscopic rotator cuff repair techniques are used. Four small incisions are made around the unstable shoulder. Under arthroscopic visualization, the torn rotator cuff muscles and tendons are repaired back to the humeral head using absorbable suture anchors and stitches. The majority of these patients have torn supraspinatus and infraspinatus tendons. The remaining two rotator cuff muscles, the subscapularis and teres minor, usually remain intact and do not need an arthroscopic rotator cuff repair. As opposed to patients with small or medium sized rotator cuff tears, these patients with large and massive rotator cuff tears are placed into a prolonged period of immobilization before they begin a physical therapy course. Most patients need 6 months to fully recover after the arthroscopic rotator cuff repair. Final study follow-up data will be obtained at the two-year postoperative time period.

6-Feb-08 9:00 PM

Relief for large rotator cuff tears with arthroscopic patch augmentation

noemail@bjc-houston.com — Mon, 17 Sep 2007 15:00:00 GMT

Rotator cuff injuries can be very painful. Until recently, very large tears were often considered to be surgically irreparable. Two young surgeons in Houston are having success with a new technique that may significantly improve your chances for recovery.

"Doc' says it's my rotary cup!" Commonly misunderstood, the rotator cuff is a group of four muscles that surrounds the shoulder and functions to provide the strength and support to perform overhead activities. People with rotator cuff disorders often have pain or weakness when trying to throw a ball, fish, play golf or tennis, or do any kind of overhead work. They may have difficulty sleeping on their side because of pain at night or trouble reaching behind their back. The problem may start suddenly, after a fall, or reaching into the back seat of the car to get a heavy briefcase, or when trying to catch or lift a heavy object. Alternatively, it may come on gradually with repetitive overhead shoulder activities at work or play with no obvious injury. Rotator cuff disorders range from tendonitis to partial tears to full thickness tears, when the muscle is completely detached from the bone.

Conservative, non-surgical treatment of rotator cuff disorders may completely resolve your symptoms. Physical therapy can loosen up your shoulder and strengthen the muscles around it. A cortisone shot, placed just on top of the rotator cuff, may relieve the pain, at least temporarily, but sometimes permanently, and can be repeated if necessary.

If you continue to have symptoms or if you cannot get back to your normal activities pain free, your doctor may offer you a surgery known as "arthroscopic rotator cuff repair." This procedure uses specially designed instruments to sew the torn rotator cuff muscle back to the bone. This is all done through three or four ¼ inch incisions around the shoulder. Using a pencil sized digital camera inserted into your shoulder for the duration of the surgery, the doctor views the action on a high definition flat screen monitor.

Partial thickness tears and small full thickness tears can be easily sewn back to the bone using an arthroscopic technique by an orthopedic sports medicine surgeon.

These specialists have completed additional training to be proficient with these special instruments and techniques. Other people may have large or "massive" rotator cuff tears, when two, three, or all of the muscles tear off the bone. In the past, they may have been told their rotator cuff tears were too large to be repaired. Now, there is a new technique offering hope for people with large and "massive" rotator cuff tears.

In the April 2007 issue of Arthroscopy, Dr. Stephen Burkhart reported original research describing improvement in both function and pain for patients with very large rotator cuff tears who would have previously been told that their tears where irreparable. Using arthroscopic techniques similar to those described in the above study, Drs. Marc Labbé and Taylor Brown of the Bone and Joint Clinic of Houston are repairing large and "massive" rotator cuff tears. Additionally, they are involved in ongoing research to continue to improve the outcome for people with this terrible shoulder problem.

Using an arthroscopic technique developed and reported by Dr. Labbé in the October 2006 issue of Arthroscopy, these two orthopedic sports medicine surgeons are adding a "patch" to strengthen the repaired muscle. Just as your grandmother might have patched a hole on the knee of your jeans with a swatch of cloth, they add a patch over the rotator cuff, sewing it down over the repaired muscle and bone. In early studies, addition of this patch has been shown to increase the success rate for people with large and "massive" rotator cuff tears. The patch is skin obtained from organ donors which has been tested and specially processed for use as a graft. Select surgeons throughout North America are involved in a study using an open technique that involves a 2 to 3 inch long scar on the side of your shoulder to place the patch. This Houston team, as well as other surgeons in Los Angeles, Dallas, and Calgary, will perform the same operation with the arthroscopic technique This study will be ongoing for the next two years before final results are reported.

17-Sep-07 10:00 AM

Better Ways to Treat Your Back Pain

noemail@bjc-houston.com — Mon, 06 Aug 2007 18:00:00 GMT

Better Ways to Treat Back Pain

THE INFORMED PATIENT

By LAURA LANDRO

Insurers, Employers Target

Excessive Scans and Surgeries

To Improve Patient Outcomes

Wall Street Journal

May 16, 2007

After recovering from injuries suffered in an all-terrain-vehicle accident a few years ago, 57-year-old Tony Georges, manager of a wetland conservation bank in Marin County, Calif., had persistent back pain that started to worsen last December and was only temporarily relieved by stretching, yoga, physical therapy and painkillers.

Diagnosed with lumbar arthritis aggravated by injury, Mr. Georges might be
considered a prime candidate for lumbar fusion, in which a surgeon fuses vertebrae on the spine together with a bone graft and, sometimes, metal screws. Wary of the surgery, which can take up to a year to fully heal, he was relieved when Brian Andrews, chairman of the neurosurgery department at Sutter Health's California Pacific Medical Center, recommended a more conservative course: continued strengthening and flexibility exercises, a consultation with a pain expert and, if needed, a pain-relieving injection that combines local anesthetic and steroids.

Dr. Andrews and several colleagues at California Pacific are among a number of physicians around the country participating in an ambitious program to improve care for 30 million Americans suffering from back pain. That number is expected to grow as aging baby boomers who lead active lifestyles face the limitations of age and degenerative diseases like osteoarthritis. Back pain sends more patients to physicians than any ailment except for the common cold and accounts for a quarter of all workers' compensation claims. It costs the health-care system more than $90 billion annually -- much of that for X-rays, CT scans, injections and surgeries that studies show are often premature or unnecessary.

The new Back Pain Recognition Program aims to reduce the number of superfluous tests and procedures and increase the adoption of treatments that are proven to work. The program is sponsored by the National Committee for Quality Assurance, an organization that monitors health-care quality and accredits health plans. Doctors and chiropractors will apply to the program and those who adhere to its treatment guidelines will be listed in the NCQA's searchable online directory and cited on consumer Web sites and provider directories offered by health plans to their members.

Studies show that as many as four in 10 imaging studies associated with lower-back pain are unnecessary, and as many as two in three epidural steroid injections are avoidable. While the rates of back surgery vary greatly across the country, the NCQA says patients often undergo aggressive treatments when less-costly and less-complicated therapy may yield similar or better results.

" 'Do no harm' is a bedrock principle of medicine, but needless tests and procedures that provide no real benefit to the patient can't do anything but harm," says NCQA President Margaret E. O'Kane.

For many patients, the most effective treatment for back pain is much less invasive. Studies show that most acute back pain usually is resolved in four to six weeks with pain management, minimal bed rest and a return to physical activity. Prolonged bed rest and limiting physical activity, which some doctors prescribe, is often not helpful and can even lead to harm, such as bed sores.

Bridges to Excellence, a group of large corporations, including General Electric Co., Procter & Gamble Co. and Ford Motor Co., will use the NCQA quality measures for its own Spine Care Link program for MDs and osteopaths; top performers in the program can earn as much as $50 a year for each patient covered by a participating employer, and will be listed on the HealthGrades Physician Quality Ratings Web site for consumers (healthgrades.com). "Overtreatment of back pain often leads to expensive and sometimes dangerous care that leaves them in worse health," says François de Brantes, coordinator of the Bridges to Excellence program.

There are currently more than 115 "early adopters" participating in the NCQA program which is open to physicians and chiropractors, who must pay fees of about $500 for the application and data-collection program the NCQA will use to assess performance.

The back-pain program is modeled on earlier recognition programs to improve care of diabetes and heart-disease patients, which employers and health plans use to pay doctors a per-patient bonus for adherence to guidelines for care -- such as making sure diabetics get regular eye exams. The NCQA is accepting applications for the back-pain program and hopes it will reach the scale of its other recognition programs, which have more than 5,500 doctors nationwide.

Large health plans including Aetna Inc. and Cigna Corp. are also participating in the program, and will steer health-plan members to doctors who win recognition from the NCQA. According to an analysis by consulting firm Towers Perrin, health plans could reduce costs by $205 per back-pain patient per year by reducing inappropriate epidural use, X-rays and CT scans, and surgical complications. Consumers will get incentives as well: Dick Salmon, senior national medical director of Cigna HealthCare, says members of its Cigna Care Network will receive a modest reduction in their co-payments for choosing NCQA-recognized doctors.

The program also seeks to ensure that patients whose back pain is a sign of something more serious or who do undergo surgery get appropriate care and are followed after surgery for complications such as infection that often lead to new problems and a diminished quality of life. There are number of widely recognized red flags that can signify that the back pain is a symptom of a more serious disorder. Those red flags include a previous cancer diagnosis, numbness or weakness in a limb, loss of bladder or bowel control, or neurological symptoms. Also, nerve roots can be compressed and paralyzed by a ruptured disk, tumor, infection, fracture or narrowing of the spinal canal, which may require emergency surgery.

"If we are going to be good spine-care providers, we have to hold each other accountable for adequate, reasonable care, without being too restrictive but without being so wide open that we waste time and effort," says Charles Branch, chairman of the neurosurgery department at Wake Forest Baptist Medical Center, who served on the advisory committee to set the standards for the program.

The NCQA will rate doctors on whether they advised patients to maintain normal activities and avoid more than four days of bed rest, and will measure the percentage of patients with back pain who received an epidural steroid injection without radiating pain. Evidence shows such injections are most effective for the treatment of pain that radiates along nerves caused by more serious conditions such as a herniated disk.

Doctors are already steering patients away from surgeries like lumbar fusion more often. "A lot of patients are worse off for having had these surgeries," says Dr. Andrews of California Pacific. "There is a movement towards less invasive, motion-sparing procedures" such as microdiscectomy, which uses a small incision to remove bone and disc material, relieving pressure on the nerve root and speeding healing from a herniated disc.

That's the procedure Dr. Andrews recommended for another patient, Dominic Swinn, a 37-year-old sales and marketing director of an online balloting site. In his case, a herniated disc was pushing against a nerve that made his leg and foot numb, prevented him from picking up his daughter and forced him to work on his laptop lying down. While the procedure required an overnight stay, "compared to normal surgery where they cut you open and you stay in the hospital for days, it was a lot less intrusive," Mr. Swinn says.

Participants in the program say one of its advantages is requiring doctors to document every step of patient care, including whether they performed a mental-health assessment, counseled smokers on quitting, educated patients about their options and provided follow-up care after surgery. Studies show that patients with back pain often are depressed or have other psychological barriers to treatment, and that cigarette smoking may increase the risk of lower-back pain.

The program may also help insulate doctors from patient demands for unnecessary drugs and tests, and from malpractice claims. "Doctors face patient pressure and the fear of litigation to go quickly to imaging and move patients to specialists," says Thomas Knight, vice president of quality at California Pacific Medical Center. "Once you get on that train, it is hard to get off."

6-Aug-07 1:00 PM

Clinical guidelines strengthened by evidence-based practice

noemail@bjc-houston.com — Fri, 27 Jul 2007 14:00:00 GMT

Formal development of clinical practice guidelines has been part of the U.S. healthcare system in various forms and from various sources for more than three decades. Initially, such guidelines were condemned by organized medicine and physicians alike as intrusive into the physician patient relationship and for promoting a "cookbook" approach to medical care that restricts individualized, innovative care and clinical practices. Fueling this debate were attempts by thirdparty payers to use proprietary guidelines to streamline healthcare management, reduce the cost of care and, some argue, improve the bottom line of those payers at the expense of patients.

Partially in response to these third-party payers and acknowledging the increasing burden on physicians to stay current with rapidly developing changes in clinical medicine, many medical specialty societies undertook meaningful clinical guideline development in the early-to-mid 1990s. The AAOS was a leader in these early efforts and has gained recognition and accolades for its work in this area.

What's wrong with consensus?
As the demand for clinical practice guidelines grew, medical specialty societies rushed to develop their own guideline products, which often ended up "competing" with similar guidelines developed by private payers or government entities. With concurrent development of multiple clinical practice guidelines on the same topic from varying sources, it rapidly became clear to even the casual observer that practice guidelines on the same clinical topic often came to
different conclusions regarding probable prognoses, diagnoses, and treatment of a clinical condition.

Well-developed clinical guidelines with rigorous literature searches can still present biased conclusions. These early guideline recommendations were often either intentionally or unintentionally consistent with the opinions and viewpoints of their development team. These guidelines also were frequently developed by a consensus-driven process, and while the validity of the conclusions of a "consensus" process can, to a degree, be systematically and igorously improved, in most cases these early guidelines often reflected merely the uniform agreement among a panel of experts with uniform and often preconceived notions.

Thus, a panel of experts might develop guidelines, making recommendations about prognosis, diagnosis and treatment of a clinical problem based upon their own expert experience and then "cherry-pick" the literature that supported these opinions. This approach has been rightfully referred to as decision-based evidence making.

Although guideline development has always been a worthwhile effort, socioeconomic needs have recently driven it to the forefront. Clinical practice guidelines are now viewed as educational aids for over-burdened physicians, as a way of promoting better healthcare outcomes, and as a means of decreasing practice variations and identifying possibly inappropriate care.

Finally, with public and private payers developing pay-for-performance systems to improve quality of care and guide reimbursement, clinical practice guideline development will play a crucial role in selecting appropriate performance measures for these new physician payment systems.

Why evidence-based practice?
During the period of consensus-driven guideline development, the tenets of evidence-based practice (EBP) were independently developed and promulgated by groups of physicians in the United Kingdom, Canada and, later, in the United States. EBP purported to improve patient care by combining the learning and experiences of the practitioner; the values and needs of the patient; and the information available from the best clinical research evidence.

Implicit in this definition of EBP was that the practitioner had to be up-to-date on the best research information available for the patient's clinical needs. In an ideal world, the practitioner would have access to large databases to search for the best information available to solve patient
needs.
Systems for formal evidence evaluation, such as Levels of Evidence, were developed to rate individual clinical studies as to their validity based on the rigor with which these studies were designed and implemented. Additional systems, such as Grades of Recommendation, were developed to rate groups of studies and grade the conclusions of these multiple studies as to how confident the practitioner could be in using these conclusions in caring for patients.

Applying the principles of EBP to guideline development has formalized the guideline development process by objectively evaluating the clinical literature into Levels of Evidence and allowing guideline recommendations to be graded on the soundness and surety of the scientific evidence supporting those recommendations. This use of evidence that is objectively evaluated according to a specific set of rules minimizes the use of informal, opinion-based recommendations and adds great transparency to the guideline development process.

As J.E. Heffner, MD, a chest surgeon, has noted, "A formal method of guideline development creates an explicit linkage between the final recommendations and the evidence on which they are based."2 Thus, the recommendations of evidence-based guidelines promote evidence-based decision making, not decision-based evidence making.

What's in a guideline?
Systematically developed, evidence-based clinical guidelines must promote safe, effective care that can be adopted by practitioners. They must be valid and reliable—meaning they should be closely linked to the available evidence and their conclusions should be based on this evidence, and not vary according to the viewpoints of the parties involved in their creation. Furthermore, the clinical outcomes of evidence-based practice should be reproducible among different caregivers who interpret and apply the guidelines similarly in similar clinical contexts.

What's the role of the expert?
Guidelines, however, must be flexible, accommodating to the use of the clinician's experience, and should allow for tailoring to an individual patient's needs and values. The guidelines should be clear, and their documentation should illustrate a transparency in the source of the guideline information and the manner in which the decisions were made in arriving at the conclusions and recommendations.

There simply is insufficient high-quality data available in the contemporary clinical literature to produce clinical guidelines with uniformly high grades of recommendation. Thus, there remains a role for expert opinion and consensus in guideline development.

The use of expert opinion as a form of "evidence" requires a formal consensus development process among the guideline creators with rigorous rules that will lead to the same attributes of validity, reliability and applicability demanded of more rigorous EBP methodology. Thus, prior to guideline development, how consensus is to be arrived at must be specified and used consistently among the guideline developers, and when consensus enters into a guideline recommendation, it must be clearly stated. Finally, evidence-based clinical practice guidelines should be created by a multidisciplinary team of developers.

The introduction of the principles of evidence-based practice into clinical guideline development means that these guidelines are no longer fully consensus-driven documents, reducing the potential for the bias of a particular group, regulatory body or payer. Evidence-based clinical practice guidelines will add to the improvement in quality, effectiveness and appropriateness of patient care.

Currently, the AAOS is actively involved in extensive clinical practice guideline development on a wide variety of topics and plans to collaborate with several other medical societies in developing multispecialty guideline products. Your Academy has committed to developing an effective and excellent process for and program of evidence-based clinical guideline development to benefit the membership by:

    1. Providing practice guidelines for common clinical problems based on the best and most     recent evidence available

    2. Providing evidence-based alternatives to the proprietary guidelines being promoted by          some third-party payers and workmen's compensation systems

    3. Developing performance measures to be provided to the Centers for Medicare and             Medicaid Services (CMS) through the AMA's Physician Consortium for Performance                 Improvement to influence CMS on the appropriate choice of such measures in a                          pay-forperformance reimbursement system.

Critical to this process is AAOS member awareness and support.

William C. Watters III, MD, is chairman of the AAOS Guidelines Oversight Committee. He can be reached at spinedoc@pdq.net.

References

    1. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington,DC:     Institute of Medicine, 2001.

    2. Heffner, JE. Does evidence-based medicine help the development of clinical practice          guidelines? Chest. 1998, Mar; 113 (3 Suppl): 172S-178S.

27-Jul-07 9:00 AM

Ethical Decision-Making in Spine Care: The Role of Evidence

Tue, 17 Jul 2007 21:00:00 GMT

Medical practitioners are facing increasing scrutiny by both the public and by regulatory bodies.1- 3 Nowhere is this more the case than in spine care.4,5 At the heart of this scrutiny is the influence of physician relationships on ethical decision making. Questions have been raised as to whether a free dinner, tickets to a play or a casual speaker’s contract with a manufacturer can affect clinical decision making. Most practitioners would deny they do, but research suggests otherwise. Something as benign as a drug company sponsoring grand rounds has been shown to influence physician prescribing habits.6 Stronger relationships such as significant stock ownership in a medical company or a highly paid “consulting” relationship with, for example, an implant manufacturer used extensively by a practitioner, only raises further, more serious questions.5

To help maintain the ethical standards of medical practice, many state credentialing bodies require annual proof of completion of a minimum degree of ethical training for health care providers. Often this requirement can be met with as little as one hour of continuing medical education (CME). Little information exists on the effectiveness of such requirements, but intuitively, as MasonCooley has noted, “Reading about ethics is about as likely to improve one’s behavior as reading about sports is to make one into an athlete.”7

Close adherence to evidence-based medicine guidelines may provide a more active method for reduction of inadvertent bias in clinical decision making. Most practitioners of contemporary medicine wish to, try to and, indeed, think they are making the best possible decisions with their patients.Nonetheless, all physicians and surgeons are subject to subtle influences and bias that can shift their decision-making process out of its appropriate clinical context into something potentially more self-serving than patient-serving.

As an example, consider the Maine Lumbar Spine Study. The Maine Lumbar Spine Study provides an excellent example of the effect of subtle differences in clinical perception and decision making.8 In this report, 655 patients with lumbar herniated nucleus pulposus (HNP) or spinal stenosis were studied prospectively. Based on the cohort’s patterns of hospital admission, small area analysis was used to develop three distinct service areas in the state of Maine In this cohort of HNP patients, the resultsof surgery were superior to medical/interventional treatment.

A closer reading of the study, however, uncovers significant differences in the operative rates for HNP (p<.001). These differences, which varied three-fold between the lowest and highest rates of surgical intervention, did not correlate with each areas’ population.

When questioned, the surgeons in the study reported they felt they had used similar indications and had similar outcomes as did all their surgical colleagues. However, the patients from the area with the lowest operative rate had significantly better outcomes than those who lived in areas with higher operative rates. Furthermore, the patients in areas with a higher surgical rate had less severe symptoms prior to their surgeries. These findings illustrate the impact that subtle influences had on the decision-making practices of the surgeons in the areas with higher operative rates. Yet,when the participating surgeons were informed of the study’s findings, they did not dispute the findings; rather, they asked what they could do to rectify the disparities. They then acted upon these recommendations.

A more active means of promoting ethical decisionmaking in patient care, reducing the potential for inadvertent bias in the clinical decision-making process, can be found in implementing the principles of evidence-based medicine (EBM).

Using the best current research evidence in clinical practice will lead to a “best practices” model of clinical care and help to reduce the undue influence of factors outside the physician-patient relationship.

Evidence-Based Practice

The Maine Lumbar Spine Study demonstrates that surgeons, even acting in good faith, can still be biased in their clinical decision-making. Yet when presented with data on best care, these same surgeons will modify their practices and improve their decision-making. Although the authors did not intend it as such, this study embodies a currently accepted definition of evidence-based practice (EBP): “The integration of the best research evidence with the practitioner’s expertise and the patient’s values.”9 This definition of EBP has three components, each equally important, much like the legs of a three-legged stool:

The first leg, clinical expertise, is a composite of the practitioner’s formal education and training prior to entering practice, the experience gained while in practice and the continuing efforts at education throughout the physician’s career through reading and CME.

But this expertise has potential limits. The longer a physician is in practice, the more likely it is that much of his or her early training will be proven incomplete or even wrong. And, while experience can be a great educator, investigations in human learning have shown the brain is vulnerable to remembering and valuing many events and experiences more as a function of their uniqueness than as a function of their usefulness. Thus, the unexpected diagnosis or unusual presentation of a common disease in a past patient can influence future diagnostic conduct out of proportion to the likelihood of that kind of finding ever being encountered
again. Finally, no matter how dedicated to the pursuit of continuing medical education, no single physician can realistically absorb all of the information available in even a single area of expertise.

The second leg of the stool, patient values, is also an important part of EBP. Each patient brings his or her own knowledge of the medical condition, a unique social experience and a set of preexisting beliefs to the physician-patient relationship. Yet while these important and often complex interactions within patient values play a role in making patient care decisions, patients continue to rely heavily on the opinions of their physicians in selecting diagnostic and
treatment choices.

The third leg of the stool that serves as the foundation for EBP is perhaps the most critical: the use of the best available current clinical evidence. Note that not all clinical research evidence is used in EBP, just the best clinical evidence. The best evidence is found by reading and rating the clinical literature into hierarchical levels of evidence and accepting and using only the most strongly recommended evidence in clinical decision-making. Note also, that while it is optimal for the best evidence in treatment decisions to be a high quality RCT, such a study may not be available, or possible to conduct. Thus it may often be the case that the best
available evidence to use in the clinical decision-making process may be a case study or expert consensus.

The practitioner can identify the best available evidence by using evidence based treatment guidelines, such as those currently being developed by NASS and its collaborative partners, by seeking out clinical literature rated as to its level of evidence and by reading systematic reviews as opposed to traditional, opinion based reviews of a clinical topic. Using the best current research evidence in clinical practice will lead to a “best practices” model of clinical care and help to reduce the undue influence of factors outside the physician-patient relationship. Thus, the three legs of EBP include a self correcting mechanism that can reduce
bias in clinical decision-making and promote the practice of ethical medicine.

References
1. Armstrong D. Delicate operation: how a famed hospital invests in device it uses and promotes. Wall Street Journal. December 12, 2005:A1.
2. Rundle R, Hensley S. Backfire: J&J’s new device for spine surgery raises questions: artificial disk aims to help body’s natural movement; some see risk if it slips. Big
money riding on this. Wall Street Journal. July 7, 2001:A1.
3. Abelson R, Petersen M. An operation to ease back pain bolsters the bottom line too. New York Times. December 31, 2003.
4. Rutchick J. Surgeon kept quiet about stake in company. Cleveland Plain Dealer. December 10, 2006..
5. Abelson R. The spine as profit center. New York Times. December 30, 2006.
6. Dana J, Lowenstein G. A social science perspective on gifts to physicians from industry. JAMA. 2003;290:252-255.
7. Cooley, Mason. City Aphorisms. Fifth Selection. New York, NY; 1988.
8. Keller R, Atlas S, Soule D, Singer D, Deyo R. The relationship between rates and outcomes of operative treatment for lumbar disc herniation and spinal stenosis. JBJS.
1999;81-A:752-762.
9. Straus S, Richardson W, Glasziou P, Haynes B. Evidence-based Medicine. 3rd Edition. London; Elsevier Churchill Livingston; 2005.

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