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Clinical Consult

Although the Guide to Physical Therapist Practice is 10 years old, it has been my experience that it is not widely used in outpatient clinical practice.  For any number of reasons initial examination formats do not appear to have changed from the SOAP to the EEDPI (Examination, Evaluation, Diagnosis, Prognosis, Intervention) method of patient/client management.  It is my belief that students who study the Guide as part of their professional education quickly give it up once they arrive in the clinic and are provided with initial exam forms in a SOAP format, usually created by therapists who have never studied the Guide or who don't understand its value.

The recent publication of Musculoskeletal Essentials, Applying the Preferred Physical Therapist Practice Patterns (Moffat, M. Editor, 2006, Slack Incorporated) attempts to better integrate the Guide into clinical care.  I am in the process of reading this book and it is raising many questions for me.  And while this post is not intended to be a review of this publication, I would like to read the comments of this blog community on the following questions.

1.  Does this Guide support EBP?
2.  Have you integrated the Guide into your practice?  Why or why not?
3.  Are the Preferred Practice Patterns a helpful classification system for you?
4.  Do the Preferred Practice Patterns improve efficiency in patient management?

Thanks and keep on blogging.
Arthur Veilleux, PT, DPT, OCS

Insiders' Game, Part 2: The COX-2 Story

More comments from the Rocky Mountain Workshop on How to Practice Evidence Based Health Care ( http://ebhc.uchsc.edu/): The rise and fall of COX-2 anti-inflammatory drugs. Lisa Bero PhD gave us an interesting perspective on the drug (and tobacco) industry’s marketing strategies, particularly illegal and deceptive strategies and tactics.

Curt Furberg MD, PhD presented a disturbing review of the last 6 yrs of the COX-2 controversy: Refocoxib (Vioxx), Celecoxib (Celebrex) and Valdecoxib (Bextra). Some background points:

1. NSAIDs had an incidence of gastrointestinal problems (PUBs) of 1-2% per year, which translated into 167,000 hospitalizations in1998 and 140,000 hospitalizations in 2001 AND 10,000-15,000 death per year!!!
2. COX-2 were designed to reduce the risk of PUBs caused by NSAIDs (which have a COX-1 action, also). 
3. COX-2 have never demonstrated superior pain control or anti-inflammation. Important point to remember.
4. COX-2s demonstrated reduced PUBs (50% Relative risk reduction, 1+ % Absolute risk reduction) in the studies published in 2000 [CLASS (Celebrex) study: Silverstein et la. JAMA.2000.284:1247-1255; VIGOR (Vioxx) study: Bombardier et al. NEJM.2000;343:1520-1528]
5. COX-2s should be used for ‘high risk of PUBs’ patients (5-10%) of the population. In 2002, prescriptions rates for COX-2s in ‘very low risk’ patients were at 40%.... Rx rates for ’low risk’ patients were at 65%!!!

Furberg’s story gets very interesting, now. The VIGOR study (Vioxx vs. Naproxen) reported a Vioxx risk ratio for Myocardial infarction (MI) of 4.25, but they interpreted the results as a protective effect from Naproxen (not a risk from Vioxx). 3 deaths were not reported or ‘disappeared’ from the Vioxx data base at the time of reporting in 2000 [see attached 'expression of concern' & ' E of C reaffirmated' by the editors of NEJM in 2005. Download curfman_morrissey_drazen. expression of concern . 05.pdf,Download curfman_morrissey_drazen. expression of concern reaffirmed. 06.pdf ] There was a higher drop-out rate in the Vioxx group, but no intention-to-treat analysis. Results from a Alzheimer's disease study demonstrated increased mortalities (RR=2.42, 1.55-3.77) were known to Merck in 2001, but publication was delayed. Vioxx was withdrawn from the market on Sept.30, 2004.

Furberg was a panelist on the Food and Drug Administration (FDA) involved in the hearings on the COX-2s 2005. The panel of 32 persons voted 3 different times on issues of  drug withdrawal, what direct to consumer (DTC) advertising constraints should be imposed and what label changes were in order. Votes were tied…until a New York Times reporter uncovered 10 of the panelists had conflicts of interest linked to drug companies involved. The FDA examined the votes: 9:1 in favor of the drug in question on each vote. Download fda_links_to_industry_cox2_vote.06.doc  The FDA purged the votes and recommendations made are now history.
Recently, a meta-analysis in the Journal of the Royal Society of Medicine Download caldwell_etla. risk. J R Soc Med.06.pdf demonstrated that Celebrex carries the same MI risk as Vioxx and Bextra…but it is still on the market. Furberg concluded that the risk is a class effect (i.e. all COX-2 drugs).  Download furberg_cd. COX-2, an update..pdf Even more alarming is the fact that the risks appear to persist after the drug is stopped (pathogenic?, toxicity?)!!! The data is still coming.
The storyline, which Furberg reiterated, was that the reporting of the initial data in 2000 was incomplete, editting errors and delayed correction by NEJM contributed to the problem, and drug companies using misleading statistics, or incomplete analyses (and data sets) were the major problems with sorting out the truth about COX-2s. These problems add up to the drug industries continued biased influence on journal reporting and review of clinical trials and corruption of the FDA control processes. Furberg called for sweeping reforms of the drug safety requirements, FDA process, stiff enforcement of violations and improved trial controls (e.g. independent statistical analyses, trial registration)Download psalty_furberg. COX, 2 drug safty.NEJM.06.pdf, Download Vioxx_Failure_NEJM_04.pdf).

More to come on the perils the drug industry poses to the integrity of medicine through corruption of the medical literature, the very foundation of the evidence-based practice, and loss of public trust: The Drummond Rennie MD lecture.

Britt 

Clinical Consult

A nurse case manager called me to ask if there was evidence of neck pain in patients with SLAP lesions.  She is attempting to use EBM to manage what she perceives as excessive treatment by a physician and PT.  She and I discussed segmental facilitation, but I told her I would ask the EIM community if they had more information than I currently have.  Does anyone?  I appreciate the help!

Jeff

Making the World of EBP PT in Minneapolis a little Flatter

This past weekend the World of Evidence Based PT in the Twin Cities of Minneapolis / St. Paul just got a little flatter.

Therapy Partners, Inc is a managed service organization that is compromised of six independent PT private practices in the Twin Cities metropolitan area (20 clinics total, 100 clinicians).  All six practices bill together under the Therapy Partners logo and name.  However, each practice is distinctly different based on clinical expertise and specialty.  As a staff therapist at one of the practices and as the research representative for all the practices, I have been concerned about the fact that if I had acute low back pain and went to each of the practices, I would receive distinctly different treatments. 

This past weekend we had a great EIM lumbopelvic course with EIM's own Rob Wainner and local PT John Groves (currently enrolled in the Regis fellowship).  I would recommend this course to anyone.  What I think the course accomplished:

1. By hosting a course for our organization, we demonstrated to our clinicians that the owners are supportive of practicing in an evidence-based manner.

2. Representatives from each practice were present - this was very important to me.  I can harp all I want about EIM and EBP, yet I never have their undivided attention.  Rob had their attention for two full days and did a fantastic job of giving them just enough information without overwhelming them.  I now have an EBP rep at each clinic that I can use to disseminate the info to his or her colleagues.  Thus, I am now less likely to get a different treatment at each location.

3. We held the course at a local PT school and two faculty members attended.  They now have a better idea of the importance of what needs to be in their curriculum and know that their students will be exposed to spinal manipulation when at a Therapy Partners clinic.  It was the first time I had collaborated with this particular university and I think I made some inroads to future collaborations, etc.

Thank You Evidence in Motion, Thank you Rob Wainner and John Groves and Thank you the College of St. Catherine.  Knowledge is Power - Blog On!!

"Overuse" Injuries - In reality should it be considered a 4 letter word?

• Have you ever considered the impact of labeling?

• For instance, in those with low back pain with signs and symptoms historically considered to be correlated with “instability” – what is the impact of telling someone they have “instability”?  Which naturally would lead to the conclusion by the patient that they have an “unstable” spine…How does that impact their fear-avoidance beliefs?  Furthermore, do they really have “instability” or do they have an underlying motor control deficit that leads to the feeling of “catching” they report?  Outside of small percentage of individuals with a frank instability – what is the impact of our label on outcomes?  How does that label influence if the patient will be more likely to be a “coper” or a “non-coper”?

• The influence of labeling on outcomes and patient’s perspectives was recently addressed in an editorial by SD Stovitz and RJ Johnson in the Br J Sports Med (2006; 40; 738-739) titled:  “Underuse” as a cause for musculoskeletal injuries: is it time we started reframing the question?.  In their opening paragraph they state:

• “Sports medicine clinicians need to be leaders in the field of physical activity promotion. As such, we must avoid language that inappropriately discourages exercise. Articles on musculoskeletal injuries typically divide the causes into either ‘‘acute’’ or ‘‘overuse’’. Both of these terms implicate activity as the basis for the musculoskeletal pain. However, as we learn more about the epidemiology, pathophysiology, treatment, and prevention of these injuries, it is clear that, in fact, inactivity may be the underlying cause of many of these conditions. ‘‘Underuse injuries’’ may be a more appropriate term to explain the aetiology of many conditions seen by those in the field of sports medicine.”

• The rest of their editorial provides support for their hypothesis.

• This just reminds me of how powerful words can be…As our society continues to become more obese and out-of-shape – should we be using words that just promotes the “wait and see” attitude or should we be using terms that promote the use of regular physical activity?

• Hope you find the editorial as enjoyable as I did.

Deydre

Clinical Consult

I have a sedentary elderly female patient 55 yrs old.  Morbidly obese diagnosed w OA x 4 yrs. ago.  PMH:HBP, Ulcers, OA, occasional SOB.  Patient here for bilateral knee pain L>R.
Pain scale L knee 8/10, R knee 5/10
Examination:
+TTP med jt line bilat, +hypomobile patella bilaterally, +Clarks (compression test).  Mild edematous Lower extremities.
Gait is slow, and mildly laborious d/t pain per patient.  Decreased D bilaterally noted, patient lacks full terminal extension at heel strike.  This is the only significant findings from gait examination.

Tx at initial evaluation:
1)Recommended Jt supplementation (Cosamin Ds)
2)HEP:Lower extremities basic strengthening/stretching e.g hip abd, quads, gastrocs, hamstrings

2nd visit/1 week later:
Patient had been compliant w HEP/jt supplementation
Pain scale L knee 6/10, R knee 1/10

Tx:Medial patellar glides bilat 2x20, this increased her pain Sx's after treatment.  Patella hardly moves, difficult to isolate d/t excessive adipose tissue surrounding knee jt.  No change in patellar mobility after tx.

3rd visit/1 week later:
Compliant w HEP/jt supplementation
L knee pain 6/10, R knee pain 3/10
Stated feeling about a bit worse.  Although pain scale difference was not much from last visit.  Due to increase in pain, I decided not to mobilize the patella today.
Patient continues to demo slow, analgesic gait.
TX:Today increased to HEP:resistive band exercises to address the previously mentioned muscles.

I'd like to know any comments/recommendations from the gang, for this compliant/nice lady. We ask for any literature on the use of manual therapy in this population.  Given the difficulty in dealing with the morbidly obese population, what can we do aside from what they have heard all their life:  "Exercise and lose weight!!"  I'm a definite advocate for lifestyle adjustments, but let's be real, how many of these folks actually run home and jump on the Jenny Craig bandwagon??  Any comments will be greatly appreciated.

Carlos Estevez, PT, MPT

Ranking Payers

EIM is in the busy planning stages of Health Care Festivus  (suggestions and volunteers welcome) which will be at the end of Sept. Part of the Festivus rituals includes the "airing of grievences".  We can beging that now by pointing out PayerView, a website that actually ranks payers according to defined metrics including how many days it take to pay "clean claims".  AMA apparently has been mentioning this site in some of their newsletters.

Thoughts?

Larry

Happy Holiday

I bet most of you didn't know that as health care providers we have a holiday coming up at the end of Sept.  This announcment as reported in WSJ (link available for 7 days for non subscribers) reports that such "holiday" was announced by the Bush administration that will withold payment of services to health care providers on medicare patients from Sept 22-30 (Congress ordered the hold).  Payments will start again after the fiscal year beginning Oct. 1.  They refer to this as a "holiday". Why don't we call it "health care festivus" and celebrate accordingly?

This announcement didn't make much in the way of news.  It is part of  demonizing of health care providers that is becoming much more prominent and subject of a future post.

I am quite sure that if the government decided to withold social security payments, mail carriers, congress, food stamps, military pay, or any other sector of the population involving the government that it would be headline news and the politicians wouldn't "stand for it" but since it represents health care providers....well...who care's?

What about the physician or physical therapy owner that treats primarily medicare patients?  This is quite damaging to their cash flow.  Would providers ever not pay their employees due to such a government holiday?

One interesting point the article makes that they do this in leiu of a reimbursement reduction.  Somebody needs to explain to them on how getting your payment late without interest is a cost reduction.

Party On!

Larry

Glucosamine: What's in a brand?

I recently did a couple of CATs Download catglucosamine_and_knee_oastructural_efficacy.doc  Download catglucosamine_and_knee_oasymptomatic_efficacy1.doc  about glucosamine supplementation due to the fact that many of my patients with osteoarthritis would ask me if it would help them along with the manual therapy and exercise I was providing them. (Plus, it fulfilled an academic assignment--kill two birds with one stone, right?)  Anyway, after searching for the most recent evidence, I found a 2006 Cochrane Review on the symptomatic efficacy of glucosamine and a 2005 systematic review of the structural efficacy of this supplementation.  It appears from the evidence that glucosamine is structurally effective at slowing the degenerative process of OA as measured by radiographic evidence of joint space narrowing.  As far as symptomatic efficacy, the evidence is not as favorable as it used to be.  In a 2005 Cochrane Review, glucosamine taken for 6 weeks improved both pain and function over placebo. But when the most recent review added newer and higher quality studies, the conclusions were not as uniform. The desired benefits of decreased pain and increased function, it seems, depended on the functional index used (WOMAC vs. Lequene) and the type of glucosamine preparation taken (Rotta brand vs. Non-Rotta brand).  The eight higher quality studies and those using non-Rotta preparations of glucosamine failed to show benefit in pain and WOMAC function.  Studies evaluating the Rotta preparation and when all 20 RCTs in the Cochrane review were analyzed together (including lower quality and older studies) glucosamine was superior to placebo in improving pain (28% improvement from baseline) and functional impairment (21% improvement from baseline) using the Lequene index, but were not superior using the WOMAC index.  So, what's in a brand?  What's unique about the Rotta brand that is making it more effective than the others in reducing pain and improving function?  I haven't found the answer yet and thought I would pose that question to the EIM bloggers.  I did a quick search around the city I live in to check prices of glucosamine supplementation and could not find the Rotta brand, but other brands sold for between $0.36 and $0.85 per dose.  I finally found the Rotta brand Dona online and it sold for about $1.17 per dose.  So do you think they know "the evidence" and are using it to their advantage?  On a side note, thanks to Rob Wainner who alerted me to a more recent article not included in the 2006 version of the Cochrane review.  In this study published in the NEJM Download Clegg_2006_NEJM_GlucosamineKneeOA.pdf they found that glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with OA of the knee.  But exploratory analyses suggested that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate to severe knee pain. (essentially the majority of OA patients who get referred to PT for therapy). Lends more evidence for subgroups and matched intervention!

In any extent, I welcome any and all comments about glucosamine brands and their effectiveness.

Evan

Use of off label drugs

Britt Smith posted on the tricky (some like to substitute illegal) marketing stategies of pharmaceutical companies promoting uses for medications that have not been approved by the FDA.  Even John Childs got in on the action with a reference in his post yesterday.  The practice of "Off Label" drug prescription is relatively common and there is a letter to the editor in July's Anesthesia and Analgesia that I thought may shed a llittle light on the subject.  Broadman LM, Semenov I. The Use of “Off-Label” Drugs. Anesth Analg. 2006; 103(1): 250-251.

Perhaps, the most classic case of off-label use of an anesthetic is the millions of times per year that caudal/epidural bupivacaine is safely and effectively used to perform spinal blocks, even though the package warns “NOT FOR SPINAL ANESTHESIA.” This is a prime example that off-label use does not necessarily mean unsafe.

This logic is very true in the case of gabapentin, the medication implicated by Dr. Rowlingson in his editorial. If it had not been for the off-label use of gabapentin by the Mellick brothers (4) for reflex sympathetic dystrophy in 1997, we would have lost access to what has become the first-line drug in the management of neuropathies associated with diabetes (5), Acquired Immune Deficiency Syndrome (6), and Guillain-Barre syndrome (7). The most recent use of gabapentin by Dr. Pandey et al. (8,9), in which gabapentin administered by mouth in a single dose on the evening prior to surgery reduced the need for narcotic analgesics by 50% in the postoperative period, provides hope that similar results can be obtained in children undergoing scoliosis surgery and other painful orthopedic procedures. In our experience, the only adverse side effect one observes with gabapentin is somnolence, a potentially beneficial side effect of a premedication.

Also I wanted to point out that there is evidence for using Anticonvulsant drugs for acute and chronic pain as indicated in this Cochrane Review.  An interesting contribution to the background of the review is that "Anticonvulsant drugs have been used in pain management since the 1960s, very soon after they were first used in medicine and revolutionised the medical management of epilepsy." 

Dan

Full disclosure: My wife is a pharmacist and although I have not been paid by "Big Pharma" for this post, the salary that my wife brings home is a substantial portion of our family's gross income.