Bone and Joint Clinic of Houston Articles RSS Feed

Platelet Rich Plasma

Taylor Brown — Sat, 15 May 2010 04:00:00 GMT

Platelet rich plasma is a method of delivering growth factors to specific injury or repair sites. Growth factors are instrumental in soft tissue healing and repair. Platelet rich plasma, or PRP, is generated from the patient's own blood and is spun down in a centrifuge to concentrate the platelet and their growth factors into a smaller volume. This platelet gel can then be injected or inserted to specific site after an injury or during a surgical repair and may enhance soft tissue healing. This is a safe technique as it is derived from a patient's own blood. The effectiveness of this technique has been investigated and has been reported to be effective as an adjunct for treatment of muscle strains and tears, chronic tendinopathy, ligament tears and ligament repairs, meniscal repairs, and arthroscopic rotator cuff repair.

Platelet gels have been inserted for decades with meniscal repair. Newer techniques and devices facilitate creation of platelet gels for easy use. Multiple manufacturers have available devices, with a cost of $300-500 per injection. Early studies have shown reduction in pain with PRP injections for tennis elbow, or lateral epicondylitis, as well as improvement of pain and function with chronic patellar tendinosis or tendinopathy. Platelet rich plasma has been used in addition to Achilles tendon repair and patients have found earlier recovery of function and range of motion with fewer wound complications than those treated with repair alone. Arthroscopic rotator cuff repair augmented with PRP has resulted in improved functional scores 2 years after surgery.

These early studies are of low scientific power. Many anecdotal reports of successful results following PRP injection with high-level athletes have encouraged the widespread use of platelet rich plasma. Conclusive evidence regarding the effectiveness of PRP with soft tissue healing will require additional studies of higher significance.

With the high safety profile and potential for improvement of outcomes with patients with complex injuries, several physicians at the Bone and Joint Clinic of Houston have begun to implement usage of platelet rich plasma, or PRP, to assist in healing with arthroscopic rotator cuff tear repair, arthroscopic meniscal repair, and healing or repair of other soft tissue, muscle, tendon, or ligament injuries. This adjunctive treatment may be a viable treatment option for chronic tendinosis or tendinopathy of the elbow or knee, Achilles tendon injuries, ACL tears and ACL reconstruction, and arthroscopic rotator cuff tear repair. Please ask your physician at the Bone and Joint Clinic of Houston if he feels that you may benefit from this modality.

http://ajs.sagepub.com/content/37/11/2259.abstract?sid=e0f39ee3-e77e-49e5-9a66-62138446c33e

http://www.jaaos.org/cgi/content/abstract/17/10/602?maxtoshow=&hits=10&RESULTFORMAT=1&andorexacttitle=and&andorexacttitleabs=and&fulltext=platelet+rich+plasma&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&resourcetype=HWCIT

14-May-10 11:00 PM

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

Taylor Brown — 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

Linda Sandoval — 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

William Granberry — 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

Taylor Brown — 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

Taylor Brown, M.D. — 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

Linda Sandoval — 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

William C. Watters III — 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

William C. Watters III — 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.

17-Jul-07 4:00 PM

To Err Is Human Quality and Safety Issues in Spine Care

David A. Wong, MD, MSc, FRC(C) and William C. Watters, III, MD� — Mon, 16 Jul 2007 18:00:00 GMT

Study Design. A review of issues linking advocacy, patient safety, and quality.

Objective. To heighten awareness of patient safety issues that require ongoing advocacy efforts by physicians treating spinal disorders.
Summary of Background Data. The 1999 Institute of Medicine report “To Err is Human. Building a Safer Health System” was a landmark publication that vaulted patient safety into the limelight of public awareness and media attention. The American Academy of Orthopedic Surgeons had addressed the wrong site surgery issue with its Sign Your Site Program even before the Institute of Medicine report. Several professional medical societies involved in spine care have made advocating for patient safety a priority.

Methods. A summary of areas of advocacy efforts involving patient safety and quality. These include the Sign Your Site Program from the American Academy of Orthopedic Surgeons, Sign, Mark and X-ray from the North American Spine Society, Joint Commission on the Accreditation of Healthcare Organizations Universal Protocol, and technology assessment. Advocacy on the Federal, state, and local levels concerning patient safety isreviewed.

Results. Awareness of patient safety issues has increased.
Several patient safety protocols (Sign Your Site,
Sign, Mark and X-ray, and the Universal Protocol) are inplace. There is increased monitoring of medical errors on the state and local, especially hospital, levels.

Conclusions. Patient safety is an absolute provision of health care. Physicians need to set a personal example for compliance with existing patient safety systems such as the Universal Protocol and be active advocates for patient safety.

Key words: patient safety, wrong site surgery, medical errors, technology assessment, advocacy. Spine 2007;32: S2–S8

This special supplement of Spine focuses on advocacy as it relates to various areas of spine care. Since publication of the Institute of Medicine1 report on medical errors “To Err is Human. Building a Safer Health System” in 1999, it has been recognized that efforts to address patient safety issues must encompass more than the clinical realm. One of the important nonclinical areas that plays a pivotal role in synthesizing effective patient safety interventions is the matter of advocacy.

This special supplement of Spine focuses on advocacy as it relates to various areas of spine care. Since publication of the Institute of Medicine1 report on medical errors “To Err is Human. Building a Safer Health System” in 1999, it has been recognized that efforts to address patient safety issues must encompass more than the clinical realm. One of the important nonclinical areas that plays a pivotal role in synthesizing effective patient safety interventions is the matter of advocacy.

In this paper, we will outline the interrelation of patient safety and advocacy that encompasses several tiers. This includes traditional advocacy on the congressional
and legislative side to regulatory and insurance issues. A reference table of abbreviations, acronyms, and terms for this topic area has been included (Table 1). We as physicians must be advocates for our patients. Many professional medical associations involved in spine care have made advocating for patient safety a priority. Safety is clearly in the patient’s best interest and a key component of quality spine care.

Issues From The Institute of Medicine Report “To Err Is Human. Building a Safer Health System”

“To Err is Human. Building a Safer Health System”1 must be considered a landmark publication. The level of awareness of patient safety issues in the minds of the
public/patients, the media, regulators, and elected officials and physicians was immediately heightened by headlines in the press suggesting that between 44,000 and 98,000 patients die in the United States every year as a result of medical errors. The 1999 Institute of Medicine
report1 was based on 2 papers. Both of these were reviews of hospital data. One report came from New York2 (part of the Harvard Medical Practice Study), and the other from Utah and Colorado.3 There were no spine specific data points collected. Some of the broad topics of
concern that may relate in a more general fashion to the spine were medication errors, infection, and technical problems of surgery. Nevertheless, the Institute of Medicine report served to focus attention on medical errors and their prevention. Other quality improvement databases such as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Sentinel Events Program provided more spine-specific information that has been the impetus for advocacy efforts by physicians, professional medical associations, and the public concerning spine issues. The potentially preventable medical error that seemed to most directly involve the spine and serve as a focus for quality improvement efforts was wrong site surgery.

“To Err is Human. Building a Safer Health System”1 has spawned a number of Federal, state, and local patient safety initiatives that we will outline. Federal patient safety legislation has passed both houses of Congress, but the regulations governing the program have not yet
been written. The “Regs” will be critical to the determination of whether the Federal program is worthwhile. State and local patient safety programs predominantly involve stricter reporting of adverse events. The involvement of physicians and professional medical organiza-

Table 1. Outline of Abbreviations, Acronyms, and Terms

Abbreviation/Acronym	Organization/Term (Web Site)
AAOS	American Academy of Orthopaedic Surgeons (http://www.aaos.org)
ACS	American College of Surgeons (http://acs.org)
AHRQ	Agency for Healthcare Research and Quality (http://www.ahrq.gov/)
GDP	Gross Domestic Product (http://en.wikipedia.org/wiki/Gross_domestic_product)
IOM	Institute of Medicine (http://www.iom.edu/)
JCAHO	Joint Commission on the Accreditation of Healthcare Organizations (http://www.jointcommission.org/)
MEPS	Medicare Expenditure Panel Survey (http://www.meps.ahrq.gov/mepsweb/)
NASS	North American Spine Society (http://www.spine.org)
NPSF	National Patient Safety Foundation (http://www.npsf.org/)
NQF	National Quality Forum (http://www.qualityforum.org/)
P4P	Pay for Performance (http://www.spine.org/nass_payforperformance.cfm)
PL109-41	Patient Safety Legislation US Congress Official Bill No. (http://www.whitehouse.gov/news/releases/2005/07/20050729.html)
PSO	Patient Safety Organization a provision of PL109-41
SMaX	Sign Mark and X-ray (NASS Program) (http://www.spine.org/smax.cfm)
SYS	Sign Your Site AAOS Program (http://www.aaos.org/about/papers/advistmt/1015.asp)
UP	Universal Protocol JCAHO Program (http://www.jointcommission.org/PatientSafety/UniversalProtocol/)
WSS	Wrong Site Surgery (http://www5.aaos.org/wrong/viewscrp.cfm#Start0)

tions in advocating appropriate and effective criteria for these proposals is vital. Several professional medical societies involved in spine care have been leaders in the development of patient safety and quality initiatives. There are a number of examples of key programs for
physician involvement and advocacy.

Advocacy Initiatives to Address Patient Safety and Quality Issues in Spine Care

Wrong site surgery of the spine has been more specifically analyzed by the American Academy of Orthopedic Surgeons (AAOS) as part of its background work for the original “Sign Your Site” patient safety initiative. A closed claims review found 11 cases of wrong level spine
surgery.4 In all instances, the incidents were related to a 1-level decompressive procedure. The clear trend was to err in operating at the level above the true pathologic segment (10 of the 11 cases).

The first AAOS Sign Your Site Program has been modified in recent years to include provisions for verification of the appropriate side and level in spinal surgery.5 A checklist is provided as a systems memory aid and documentation instrument. The Sign Your Site Program has always been a voluntary initiative among members of the AAOS. Utilization of the Sign Your Site Program among AAOS fellows has been somewhat mixed over the years. The Wrong Site Surgery Task Force estimated that about 1 in 4 orthopedic surgeons would be involved in a wrong site surgery in their practice lifetimes.5 This seemed to strike most members as a relatively low risk. Thus, advocacy efforts by the AAOS leadership to incorporate the Sign Your Site Program into daily practice have proven an uphill battle. Nevertheless,
the Academy has been recognized as a leader in proactively addressing quality and patient safety issues such as wrong site surgery. These efforts have influenced a number of initiatives in professional medical societies and regulatory agencies.

The North American Spine Society (NASS) refined theoriginal Sign Your Site advisory into a more detailed and comprehensive program dealing with the identification of the appropriate
level and side of the spine for surgical intervention. This plan was christened the “Sign, Mark
and X-ray” program.6 The 3 essential components of the Sign, Mark and X-ray program are:

Sign the surgical site before surgery (similar to the original AAOS Sign Your Site Program). In the marking process, it is helpful to note the level(s) of the surgery and sign the surgeon’s initials on the side of the approach if surgery is to be 1 sided (Figure 1).
Mark the level in the operating room with a radiopaque indicator on a bony landmark, such as a towel clip on a spinous process.
Radiograph the spine as a routine part of the procedure with the marker in place to confirm the level of pathology.

The program includes a more comprehensive checklist for the various steps that also addresses issues such as patient identification, verification of the surgical proce-

Figure 1. Example of lumbar spine site marking visible at draping. Head is to the top and buttocks to the bottom of the field. Initial indication of side and level are noted by marking the pathologic level(s), in this case L5–S1, to the left side of the spine as the patient had a left–sided herniated disc, and dissection was
planned from the left-sided approach only.

dure to be performed, and the presence of appropriate medical records, imaging studies, and equipment.
In terms of regulatory agencies advocating for patient safety and quality issues, the JCAHO has been a prime mover. The JCAHO “Sentinel Event” system began monitoring major quality issues in the late 1980s, about the same time as the original AAOS Sign Your Site Program was launched. A Sentinel Event is defined as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.”7 In addition to the statistical reporting aspect of the program, a quality review is triggered that requires a “root cause analysis” to try to determine factors contributing to the occurrence of a Sentinel Event. This analysis offers the opportunity to advocate preventive measures and solutions, and is a key provision beyond basic statistical reporting in the effort to improve quality of care.

The JCAHO also advocates a yearly set of “National Patient Safety Goals.”8 These goals are more general in nature and involve many areas of medical care. However,
some goals have indirect implications for the treatment of patients with spine pathology (patient identification, medication safety, reduce surgical fires). The JCAHO patient safety program that has the most direct implications for spine care is the “Universal Protocol” for the prevention of wrong person, wrong site, and wrong procedure surgery.9

JCAHO Universal Protocol

The Universal Protocol was a logical extension of the Sentinel Events quality improvement program. Wrong site surgery is considered a Sentinel Event. Because of the mandatory reporting of Sentinel Events, some of the best data on the incidence and anatomic location of wrong site surgeries come from the JCAHO. Interestingly, analysis of the Sentinel Events data revealed additional issues beyond wrong site incidents involving right versus left or spinal level. Before implementation of the Universal Protocol, the JCAHO analyzed 278 reports of wrong site surgery in the Sentinel Events database up to 2003.10 This review showed that in 10% of cases, the wrong procedure had been performed. In another 12%, surgery had been performed on the wrong patient. A further 19% of the reports characterized miscellaneous wrong sites such as the wrong digit on the correct hand or the wrong joint on the correct finger. Thus, it was felt that a protocol to address the issues must include provisions to avoid wrong patient, wrong procedure, as well as wrong site surgery.

In May of 2003, the JCAHO convened a “Wrong Site Surgery Summit” to look into possible quality initiatives in this area. The AAOS and the American College of Surgeons, two professional medical organizations that had already been strong advocates for quality interventions, cosponsored the meeting. Representatives of over 40 societies discussed the issues, reviewed data, and divided into work groups to consider solutions to some of the specific issues, such as site marking. The senior author(D.A.W.) represented the AAOS and NASS at the Wrong Site Surgery Summit. The products from the Summit work groups contributed to the initial formulation of the Universal Protocol.

The JCAHO also had field test results from institutions with various protocols to prevent wrong site surgery. The 3 most effective were designated as “Key Processes”
for: (1) patient identification; (2) surgical site marking; and (3) calling a “time out” before skin incision to verify factors such as the initial patient identification, patient allergies, completion of preoperative interventions such as intravenous antibiotics, the procedure to be performed, available medical records, imaging studies, equipment, etc. When correlated to Sentinel Event data, it was found that only 12% of wrong site surgeries occurred in institutions with 2 of 3 protocols in place. More importantly, no incidents of wrong site surgery had come from hospitals using all 3 key processes.11 The 3 “Key
Processes” thus became the core elements of the Universal Protocol (patient identification, surgical site marking, and “time out”). The JCAHO Universal Protocol became a mandatory quality screen in all JCAHO accredited hospitals July 1, 2004.

JCAHO Sentinel Event Statistics and the Spine

Figures are available from the JCAHO Sentinel Event database with specific reference to wrong site surgeries involving the spine. Analysis of the data up to 200310 showed wrong site surgery to be the third most frequent Sentinel Event, representing 278 of 2299 (12%) total incidents, following inpatient suicide 357 cases and operative/ postoperative complications 292 cases (Table 2). Of the 278 wrong surgeries, 8% involved the spine. The first full year’s statistics following implementation of the Universal Protocol on July 1, 2004, have recently been assembled (R. Croteau, unpublished data, 2006). In this time period, the proportion of wrong site surgeries involving the spine had dropped to 5% (Table 3), and rank fell from fourth to ninth.

Overall Wrong Site Surgery Statistics Before andAfter the Universal Protocol

With the advocacy efforts of the AAOS, NASS, and JCAHO, as well as other professional medical and regulatory agencies, hope was high that the implementation
of the Universal Protocol July 1, 2004, would result in fewer cases of wrong site surgeries. The first 2 quarter statistics after implementation were encouraging.12 It
appeared that reports of wrong site surgeries had declined below the rate of approximately 70 cases per year for the previous 2 years. However, after a full year’s
statistics had been accumulated, it was found that the incidents of wrong site surgery had actually increased to about 88 for 2005 (R. Croteau, unpublished data, 2006).
Overall, wrong site surgery had climbed to the number 2 ranking in frequency of Sentinel Events (behind inpatient suicide) (Table 2). Whether these data represent a true increase in the frequency of wrong site surgery or are

Table 2. Ranking JCAHO Sentinel Events Before and After the Universal Protocol by Frequency

Ranking	Sentinel Events Before Universal Protocol Analysis of 2299 Cases January 1995–September 2003	%	Ranking	Sentinel Events After Universal Protocol Analysis of 3548 Cases January 1995–December 2005	%
1	Inpatient suicides	357	1	Inpatient suicides	464
2	Operative/postoperative complications	292	2*	Wrong site surgery	455
3*	Wrong site surgery	278	3	Operative/postoperative complications	444
4	Medication errors	264	4	Medication errors	358
5	Death related to delay in treatment	145	5	Death related to delay in treatment	269
6	Death patients in restraints	111	6	Patient falls	189
7	Patient falls	104	7	Death patients in restraints	138
8	Assault/rape/homicide	81	8	Assault/rape/homicid	121
9	Transfusion-related events	66	9	Perinatal death/injury	109
10	Perinatal death/injury	58	10	Transfusion-related events	94

Bold indicates the specific topic of interest (wrong site surgery).
* Wrong site surgery is the sentinel event with specific statistics referable to spine.

simply explained by better awareness and reporting is unclear at this time. The JCAHO is presently performing a subanalysis of the data for clarification.
This paradoxical result compared to the anticipated reduction in the incidence of wrong site surgery has caused some soul-searching at the AAOS, NASS, and
JCAHO. The three organizations are engaging in a dialogue to revamp and reinvigorate advocacy efforts to prevent wrong site, wrong procedure and wrong patient
surgery.

Advocacy Versus Apathy/Push Back for Patient Safety by the Individual Physician

Beyond the involvement of professional medical societies, effective advocacy on the individual physician level is required for systems solutions such as the Sign Your Site
Program, Sign, Mark and X-ray program, and Universal Protocol to be effective. On an individual, personal basis, physicians will generally respond that “of course” they
are patient safety advocates. Paradoxically, there has been considerable “push back” from physicians for implementation the Sign Your Site Program, Sign, Mark and X-ray program, and Universal Protocol. The AAOS, NASS, and JCAHO are contemplating different education and awareness strategies. For example, more emphasis on education and changing the culture of patient safety in the minds of residents and fellows has been
suggested. Established physicians, with a relatively low 1 in 4 surgeon (or approximately 1:36,600 career cases) risk of performing a wrong site surgery sometimes relate that they find the protocols intrusive and unnecessary. We should recognize, however, that 36,000 invasive procedures are about the average that is done at our 680-bed medical center. Thus, on an institutional basis, the risk for a case of wrong site surgery is about 1 per year, and, thus, definitely on the radarscope of chiefs of medical staff, hospital administrators, and patients. The issue of wrong site surgery has definitely not gone away in the years since the Institute of Medicine1 report. We as individual physicians can be better patient safety advocates.

Additional Thoughts on Why Medical Errors Such as Wrong Site Surgery Still Occur

A principle often heard at patient safety seminars is “Culture eats strategy for lunch.” This situation cer-

Table 3. Analysis of Anatomic Location of Wrong Site Surgeries Before and After the Universal Protocol

1	Knee	17	1	Knee	13
2	Foot/ankle	10	2	Mouth/pharynx/larynx	12
3	Hand/Wrist	9	3	Cranium	8
4*	Spine	8	4	Hand/wrist	6
5	Cranium	6	5	Chest	6
6	Hip	6	6	Peripheral vascular	6
7	Hernia	5	7	Abdominal cavity	6
8	Chest	5	8	Eye	6
9	Male genitalia/prostate	5	9*	Spine	5
10	Mouth/pharynx/larynx	5	10	Hernia	5

Percent cases by anatomic site.
Bold indicates the specific topic of interest (wrong site surgery).
* Wrong site surgery is the sentinel event with specific statistics referable to spine.

tainly applies to implementation of patient safety strategies. Ingrained and long-standing practice cultures of physicians, nurses, other health care providers, as well as clinics and hospitals, are sometimes difficult to change. The relatively low incidence of major medical error per medical provider also tends to generate a state of complaisance and apathy.

Another issue that tends to affect the persistent occurrence of medical errors is the status of medicine as a complex interactive system. Analysis of many medical errors suggests that systems factors are an ongoing concern, predisposing to the occurrence of medical errors.13
Examples of systems areas undergoing review are patient identification, medication identification and dosage confirmation, legible/understandable/accurate order entry, detection of drug interactions, and recognition of potential complications.

Advocacy for Patient Safety in the Federal Administration

Following introduction of the Institute of Medicine1 report “To Err is Human. Building a Safer Health System” in 1999, the Federal government convened an interagency task force to evaluate issues regarding medical errors in their agencies and to advocate strategies for improvement of patient safety. Dr. John Eisenberg, Director of the Agency for Healthcare Research and Quality (AHRQ), chaired the task force. There were 11 participating agencies and departments, including Health and Human Services, Veterans Affairs, and Labor. The report from this task force was sent to the president in 2000.14 The task force advocated creating a Center for Quality Improvement and Patient Safety within the AHRQ. A number of public/private cooperative initiatives were also suggested between the government and organizations, such as the National Quality Forum and National Patient Safety Foundation. The report also contained discussion of other strategies such as establishment of nationwide reporting systems, peer review protection for reporting of medical errors, safe use of drugs and devices, role of information technology, and building public awareness of medical errors. Many of these issues have been integrated into subsequent patient safety legislation.

Advocacy for Patient Safety in the Washington Legislative Arena

Important patient safety legislation has recently passed in both the U.S. House and Senate (PL109-41, signed into law July 29, 2005). The legislation provides for formation of “Patient Safety Organizations” (PSOs) to serve as recipients of patient safety reporting data. The 4
main provisions of the legislation are: (1) outline procedures for voluntary, confidential reporting of medical errors to PSOs; (2) specify PSOs as a government certified
entity; (3) provide legal protections/privilege for error reports; (4) authorize submission of nonidentifiable patient information to a national database to be established at the AHRQ for the purpose of analysis and identification of patient safety improvement solutions.

There have been significant advocacy efforts by the professional medical and spine societies regarding provisions of this legislation. The legislation itself was somewhat
vague as to whether all functions of a PSO would be considered protected peer review activity, and, thus, safeguard the organizations and participating physicians from lawsuits arising from legitimate quality improvement activities. Peer review protections are clearly a key element to having an effective patient safety reporting system.
The specific provisions governing the day-to-day application of any legislation passed into law are more specifically outlined in subsequently written “regulations” or “regs.” The regs for PL109-41 have not as yet been published. Ongoing advocacy efforts are in place to emphasize the importance of full peer review status for PSOs. Hopefully, these provisions will be included in the regulations and enhance efforts to develop a useful data reporting system while still protecting patient and physician confidentiality.
On another Federal level, the Center for Medicare and Medicaid Services has launched voluntary quality programs that include performance measures considered by some to be patient safety as well as quality issues. The measures having relevance to spine in the initial quality set are use of prophylactic antibiotics for surgery and appropriate use of prophylaxis for deep venous thrombosis. These measures may also have relevance to Federal Pay for Performance initiatives. Criteria for acceptable compliance with the quality measures have yet to be established.

Advocacy for Patient Safety and Quality on the State Level

State-based initiatives involve primarily reporting and education. Approximately 22 states have patient safety reporting systems. These are generally mandatory and are of limited scope, usually involving patient deaths, infections, or major life or limb-threatening adverse events. Even with mandatory reporting, there remains reluctance on the part of providers to report. Concerns generally center on the conflict between maintaining the confidentiality of the physician and patient versus sufficient disclosure of incident details to provide a basis for
the development of patient safety solutions. Fears persist concerning litigation, discoverability, and regression to the old “name, blame and shame” state of affairs.15 Most state reporting systems require reporting of hospital data only, and function as data repositories and public reporting agencies. The limited scope of these programs restricts their effectiveness in the patient safety and quality arena. However, it is still important to monitor these state organizations and advocate for appropriate handling of the data.

Advocacy, Patient Safety, and Tort Reform

The development of effective patient safety interventions is a data-dependent exercise. Thus, our present tort system is a major impediment to realization of a successful patient safety agenda. The basic incompatibility lies in the reluctance of physicians to report safety data under the potential hammer of our present professional liability structure. Other complex, interactive systems such as the airline industry have clearly demonstrated the utility of “no fault” reporting systems to generate the data required for identification of safety issues. Without effective problem identification, there can be no effective patient safety and quality interventions. Tort reform is thus an important element of our patient safety agenda and
worthy of additional advocacy efforts.

Advocacy, Patient Safety, and Technology Assessment

In the context of advocacy and patient safety, technology assessment must be viewed in broad terms. It encompasses evaluation of the safety of new technology as well as surveillance of existing technology for safety concerns. Consider new technologies such as total disc arthroplasty, where safety issues have been cited concerning anterior revision strategies and the potential for lifethreatening vascular complications.16,17 The use of bone morphogenic proteins has raised concerns about off label use in the cervical spine.18

Existing technology has ongoing patient safety challenges. In the last year, the NASS and AAOS have issued patient safety alerts concerning dangers of several existing technologies frequently used in spine surgery. Two such alerts have included bone allografts often used in
spine applications. Safety issues were raised concerning procurement and possible tissue contamination in 1 occurrence19 and with the processing of the tissue in a separate
instance.20 Another alert was issued relating to bacterial contamination of nearly 380,000 vials of Cephazolin, 21 the most commonly used antimicrobial for prophylactic intravenous antibiotic treatment before spinal surgery and a frequent addition to surgical irrigation used in spine procedures. Diligence and advocacy for patient safety must be maintained in the areas of both new and existing technology.

Discussion

Patient safety is an absolute provision of health care. Physicians have traditionally been the primary advocates of safety and quality. As far back as the Hippocratic era (460 –370 BC), “primum non nocere” (first do no harm)22 has been a key tenet of medical practice. Over
the millennia, major advances in medicine have required corresponding major advocacy efforts to define and prioritize the standing of those interventions, be they in regard to disease processes, diagnostic procedures, or various treatments alternatives. In our present health
care structure, advocacy and patient safety are clearly interactive components of a multifaceted delivery system.

Consider the standing and prioritization of spine care in our society. Luo et al23 analyzed expenditure data for low back pain for the year 1998, the most recent year for which U.S. Medicare Expenditure Panel Survey data were available. They found that the expenditures for
back pain in the United States totaled approximately $91 billion or about 1% of the U.S. gross domestic product. The total expenditure for health care was $1.2 trillion (13.6%) of gross domestic product.

With a recognized priority position in health care, strategies need to be developed (and advocated) to operationalize the integration of patient safety and advocacy for spine care. A systems approach has generally been proposed as a rational solution.24 Systems generally make it harder for good people to commit errors. Barriers to implementation of these systems have been recognized25,26 and strategies proposed to counter these obstructions. The late director of the AHRQ, Dr. John Eisenberg advocated an innovative strategy based on continuous medical education.27 Elimination of the traditional “name, blame and shame” approach to medical errors was a component of this strategy.

Summary

To err is indeed human. As physicians and advocates for our patients, each one of us needs to set a personal example for compliance with existing patient safety and quality systems such as the Universal Protocol. As recognized opinion leaders in the area of patient safety, spine practitioners can have a principal role in developing functioning and effective patient safety, quality, and advocacy systems for the future.

Key Points

Patient safety is an absolute provision of health care.
Physicians need to set a personal example for compliance with patient safety systems such as the Universal Protocol.
Physicians must be patient safety and quality care advocates.
Examples of patient safety systems are the JCAHO Universal Protocol for prevention of wrong person, wrong procedure, and wrong site surgery, Sign Your Site from the AAOS, and Sign Mark and X-ray from the NASS.

References

Institute of Medicine. To Err is Human. Building a Safer Health System. Washington, DC: National Academies Press; 1999. Available at: http:// newton.nap.edu/catalog/9728.html. Accessed August 21, 2006.
Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370–6.
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