The Myth Busters: Evidenced-Based Guidelines in Practice Kathryn Mueller, MD,MPH Medical Director , DOWC Professor, Schools of Medicine and Public Health

1
The Myth BustersEvidenced-Based Guidelines in
PracticeKathryn Mueller, MD,MPHMedical
Director , DOWCProfessor, Schools of Medicine
and Public Health
2
Disclaimers

• Scientific Advisory Committee and Consultant
  Workers Compensation Research Institute
• International Scientific Advisory Board MedRisk
• Regular Speaker for American Board of Independent
  Medical Examiners

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What is evidence-based medicine?

• Thorough and transparent literature search
• Restricted study type used appropriate to the
  study question
• Clear criteria for evidence grading that show
  documented compliance
• Preferably strict analysis of statistical methods
  and redo of meta-analysis
• External validation and recommendations from a
  non-biased multi-disciplinary review panel
• Further vetting through peer reviewers

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Goals

• To provide the best medical care that will result
  in the highest quality of life (functional
  result) for our workers
• We know that concentrating on cutting medical
  costs alone as has been done by many general
  health insurers does not decrease costs long
  term
• Improving quality of life and decreasing
  disability is a goal in workers compensation

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12 Guidelines Recommendations and Inclusion of
Medical Evidence Expert Evidence

• C Some at least one adequate scientific study
• B Good multiple adequate scientific studies
  or one relevant high-quality scientific study
• A Strong multiple relevant and high quality
  scientific studies -Further research unlikely to
  have an important impact on the interventions
  effect
• Procedures considered unreasonable, or
  unnecessary are designated as not recommended.
• All recommendations in the Guidelines represent
  reasonable care in specific cases regardless of
  evidence level attached

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Consensus Values

• Functional benefit to patient (pain relief not
  enough)
• Acceptable risk and morbidity
• Length of disability and timeframe to recovery
• Acceptable cost

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Derivation of Evidence Recommendations

• Volume of evidence
• Consistency of evidence
• Generalizability
• Clinical impact
• Study type and quality - A study may be
  statistically significant but not have meaningful
  impact

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Importance of Randomized Controlled Trials

• Class 1 Recommendations from American College
  Cardiology American Heart Association Clinical
  Practice Guideline
• 619 Recommendations 80 495 down graded.
• Likelihood of being down graded due to lack of
  RCT based on opinion rating (odds ratio, 3.14,
  95 CI 1.69-5.85, Plt.001).
• Based on observational studies 3.49 CI,
  1.45-8.41P.005).

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LOWER EXTREMITY INJURY MEDICAL TREATMENT
GUIDELINES Colorado 2015

• Bibliography 582
• Critiques - 216

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Occupational Medicine Principles

• Diagnostic testing should only be done when the
  results will change the treatment
• Functional progress should be measured and
  tracked
• The goal of all treatment in non-cancer cases is
  functional progress not necessarily the
  elimination of pain
• For most musculoskeletal conditions patient
  dedication to active therapy is essential

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Achilles tendon Complete Rupture

• Requires a surgical repair
• True or False

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ACHILLES TENINOPATHY OR INJURY RUPTURE

• For non-operative treatment of a complete
  Achilles tendon rupture, weight-bearing in the
  first week is safe and appropriate ( Kearney,
  2012).
• Conservative Management likely requires more
  imaging, typically dynamic ultrasounds, in order
  to ensure appropriate healing.

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SURGERY

• Good evidence operative repair of a complete
  Achilles tendon rupture does lower the re-rupture
  rate when compared to non-operative
  immobilization
• It also increases the rate of other complications
  including deep tissue infection (Cochrane, Khan,
  2010).
• AAOS agrees surgical repair not required

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Steroid Injections

• Steroid Injections provide only short term relief
  for which of the following?
• A Herniated discs
• B Shoulder impingement
• C Epicondylitis
• D All of the above

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Injections Diagnostic Epidural Steroid
Injections (ESIs)

• Strong evidence epidural steroid injections have
  a small average short term benefit for leg pain
  and disability for those with sciatica (Pinto,
  2012).
• Good evidence the addition of steroids to a
  transforaminal bupivacaine injection has a small
  effect on patient reported pain and disability
  (Ng, 2005 Tafazal, 2009).

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Injections Diagnostic Epidural Steroid
Injections (ESIs)

• Some evidence additional steroids may reduce the
  frequency of surgery in the 1st year for patients
  with neurologic compression and corresponding
  imaging findings.
• Patients were strong candidates for surgery and
  had completed 6 weeks of therapy without adequate
  benefit (Riew, 2000).
• Some evidence the benefits for the non-surgical
  group persisted for at least 5 years in most
  patients, regardless of the type of block given
  with or without steroids (Riew, 2006)

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Injections Diagnostic Epidural Steroid
Injections (ESIs)

• No proven benefit from adding steroids to local
  anesthetic spinal injections for most injections.
• Steroids are currently used routinely in spinal
  injections due to a presumed physiologic effect.
• Therapeutic spinal injections have not been
  proven to change the long term course of most
  patients with spinal pain.

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Injections Glucocorticosteroids

• Ten Studies
• Natural history is to improve or resolve
• Strong evidence of short term benefit. But,
  strongly recurrent such that no evidence of
  altering long term prognosis
• If non-invasive therapy fails to improve
  condition over 3-4 weeks
• Evidence (B), Moderately Recommended. ACOEM
  guidelines

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Smidt, Nynke et al. Corticosteroid injections,
physiotherapy, or a wait-and-see policy for
lateral epicondylitis a randomised controlled
trial. Lancet, February 23, 2002 359657-662.
Cortisone efficacy for epicondylitis treatment
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Rotator Cuff Impingement

• Strong evidence subacromial steroid injections
  for rotator cuff tendinopathy can produce rapid
  benefit.
• No evidence it differs from alternative
  therapies for intermediate or long-term relief.
  (Coombes, 2010)

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Clinical Case

• A 60 year old male working at a hardware store
  was doing seasonal restocking. For at least 3
  hours per day he was lifting boxes weighing 20-25
  lbs. to shelves over his head. After 1 week he
  noticed significant pain in his left shoulder.
  Two week into the restocking the pain is
  interfering with sleep and he cannot lift above
  shoulder level.

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Clinical Case

• Past History
• No other health issues.
• Historically he was an avid skier and mountain
  biker however, he denies any injuries to his
  shoulder.

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Clinical Case

• P.E.
• Right shoulder normal exam
• Left shoulder
• Drop arm negative
• Hawkins painful
• Neer positive
• Jobe Empty can positive
• ROM very painful 60-120
• Vascular, sensation neck exam - normal

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Questions

• Are any imaging tests needed?
• What should initial treatment be?
• When should injections be considered?
• When should surgery be considered?

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Rotator Cuff Impingement

• Strong evidence that
• Exercise has a small to moderate effect in
  reducing pain and improving function in the short
  term and exercise has a small to moderate effect
  in improving function in the long-term.
  (Hanratty, 2012)

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Rotator Cuff ImpingementOperative

• Impingement without a rotator cuff tear might
  include bursectomy with or without acromioplasty.
• Acromioplasty is not
• generally recommended.
• Distal clavicle should
• not be removed unless there is AC joint pain
  reproducible with direct compression.

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Rotator Cuff Tear

• Some evidence in patients over 55 with
  nontraumatic small tears of the supraspinatus
  tendon, an intervention of home exercise
  supervised by a shoulder-trained physiotherapist
  may be as beneficial at one year as the same
  physiotherapy program initiated after
  acromioplasty or acromioplasty with repair of the
  rotator cuff. (Kukkonen, 2014)

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Plasma Rich Protein (PRP)

• Good evidence for rotator cuff tendinopathy, a
  single dose of PRP provides no additional benefit
  over saline injection when the patients are
  enrolled in a program of active physical therapy
  (Kesikburun, 2013).

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Plasma Rich Protein (PRP)

• Strong evidence that platelet rich therapy does
  not show a clinically important treatment effect
  for shoulder pain or function when given as an
  adjunct to arthroscopic rotator cuff repair.
  (Cochrane Moraes, 2013 Gumina, 2012a Lee,
  2012b Mall, 2014).

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AAOS

• Moderate evidence in favor of exercise first if
  not a full thickness tear
• Moderate evidence against a routine acromioplasty
• Limited evidence for an acute tear repair

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Which of the following operative procedures
should usually be performed on a 65 y/o?

• Debridement and lavage to delay knee arthroplasty
• Repair of a medial meniscus degenerative tear
  which is not causing locking
• Repair of an acute ACL tear which is not causing
  severe dysfunction
• All of the above

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OSTEOARTHRITIS KNEE

• Good evidence for self-management using weight
  loss, exercise, pacing of activities, unloading
  the joint with braces, taping, and medications as
  needed (BMJ Clinical Evidence Scott, 2008).
• Good evidence exercise shows moderate, clinically
  important reductions in pain and disability in
  people with osteoarthritis of the knee (Juhl,
  2014).
• Activities such as ladders, stairs and kneeling
  may be restricted.

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KNEE OPERATIVE

• Surgical Indications/Considerations
  Arthroscopic Debridement and/or Lavage Good
  evidence from a randomized controlled trial
  arthroscopic debridement alone provides no
  benefit over recommended therapy for patients
  with uncomplicated Grade 2 or higher arthritis.

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KNEE OPERATIVE

• The comparison recommended treatment in the study
  followed the American College of Rheumatology
  guidelines, including
• Patient education
• Supervised therapy with a home program
• Instruction on ADLs
• Stepwise use of analgesics and
• Hyaluronic acid injections if desired (Kirkley,
  2008).

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KNEE OPERATIVE

• Arthroscopic debridement and/or lavage are not
  recommended for patients with arthritic findings,
  continual pain and functional deficits unless
  there is meniscal or cruciate pathology operative
  meeting criteria in those sections or a large
  loose body causing locking (AAOS, 2013).
• Inadequate evidence of the effectiveness of PRP
  in the setting of microfracture in patients with
  knee OA over the age of 40 (Lee, 2013) not
  recommended.

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AAOS Knee Osteoarthritis

• Strong evidence for exercise
• Strong evidence against hyaluronic acid
• Insufficient evidence to recommend steroids
• Strong evidence against lavage, debridement or
  degenerative meniscus repair

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How about meniscus tears?

• In a patient without locking what are the
  considerations for surgery?

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MENISCUS INJURY

• Occupational Relationship Trauma from
  rotational shearing, torsion, and/or impact
  injuries while in a flexed position.
• Good evidence from a meta-analysis of
  observational studies that there is an increased
  risk of degenerative meniscal tears with
• Age over 60
• BMI over 25
• Male gender
• Work-related kneeling an squatting and
• Regularly climbing greater than 30 flights of
  stairs per day for 12 months (Snoeker, 2013).

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MENISCUS INJURY

• Meniscal MRI is frequently abnormal in
  asymptomatic patients.
• One study of volunteers without a history of knee
  pain, swelling, locking, giving way, or any knee
  injury
• 16 of the volunteers had MRI-evident meniscal
  tears and
• 36 of volunteers older than 45 had MRI-evident
  tears (Boden, 1992). Clinical correlation with
  history and physical exam findings specific for
  meniscus injury is critically important.

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MENISCUS INJURY

• Good evidence in the initial management of knee
  OA with a torn meniscus, it is reasonable to
  start with non-operative physical therapy.
• Good evidence that about 30 of patients may not
  respond to PT alone (Katz, 2013).

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MENISCUS INJURY

• Good evidence in patients with non-traumatic
  degenerative meniscal tears who have full knee
  range of motion and mild or no osteoarthritis,
  whose symptoms have not resolved with 3 months of
  conservative treatment and
• That both arthroscopic partial meniscectomy and a
  sham diagnostic arthroscopic intervention are
  followed by clinically important improvements in
  pain and function.

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MENISCUS INJURY

• Arthroscopic meniscotomy is not superior to the
  sham diagnostic procedure which leaves the
  meniscus intact (Sihvonen, 2013).
• Strong evidence partial meniscotomy provides no
  clear benefit over initial exercise therapy for
  patients with an isolated degenerative meniscal
  tear. Therefore, is not recommended.

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Questions??

• Surgery not required for Achilles tendon rupture
• Manual therapy frequently a useful adjunct
• Exercise therapy has some benefit for knee
  osteoarthritis
• ACL tears may be handled conservatively initially

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Clear ACL Tear

• Should surgery be scheduled for all cases?
• What are the considerations?

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ANTERIOR CRUCIATE LIGAMENT (ACL) INJURY

• Non-operative Treatment Procedures Some
  evidence referring to physical therapy with an
  option for delayed surgery can be expected to be
  as successful at 5 years as early surgery.
• This delayed surgery treatment plan may make some
  ACL operations unnecessary (Frobell, 2013).
• However, over 1/3 of patients eventually had an
  ACL reconstruction.

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AAOS - ACL

• When ACL reconstruction is indicated, moderate
  evidence supports reconstruction within five
  months of injury to protect the articular
  cartilage and menisci.
• There is limited evidence to support nonsurgical
  management for less active patients with less
  laxity
• There is limited evidence comparing nonoperative
  treatment to ACL reconstruction in patients with
  recurrent instability, but it supports that the
  practitioner might perform ACL reconstruction
  because this procedure reduces pathologic laxity.
• Moderate evidence supports surgical
  reconstruction in active young adult (1835)
  patients with an ACL tear.

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OSTEOARTHRITIS KNEE

• Medications Good evidence duloxetine more
  effectively decreases knee OA pain in older
  adults than placebo (Abou-Raia, 2012 Chappell,
  2009 McAlindon, 2014).
• Glucosamine and Chondroitin Good evidence the
  glucosamine sulfate and glucosamine hydrochloride
  are ineffective for relieving pain in patients
  with knee or hip OA (Wu, 2013).

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OSTEOARTHRITIS KNEE

• Aquatic therapy may be used as a type of active
  intervention when land-based therapy is not
  well-tolerated.
• Proprioceptive exercises may also have some
  short-tem benefit (Smith, 2012).
• Manipulation/Manual Therapy Good evidence
  supervised exercise therapy with added manual
  mobilization shows moderate, clinically important
  reductions in pain compared to non-exercise
  controls in people with osteoarthritis of the
  knee (Jansen, 2011 Hochberg, 2012 VA/DoD,
  2013).

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OSTEOARTHRITIS KNEE

• Acupuncture Good evidence neither laser nor
  needle acupuncture reduces pain or improves
  function in patients older than 50 years with
  moderate to severe chronic knee pain (Hinman,
  2014).
• Strong evidence acupuncture is not effective for
  osteoarthritis pain relief. It is not generally
  recommended but may be used in some patients in
  functional gains are demonstrated and it would be
  beneficial to delay arthroplasty (Hochberg, 2012).

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KNEE INJECTIONS

• Steroid injections may decrease inflammation.
  Caution should be used when considering steroid
  injections for patients with an A1c level of 8
  or greater (Shilling, 2008).
• Good evidence steroid injection in the setting of
  knee osteoarthritis produces rapid but short term
  pain relief compared to placebo, not likely to
  last 4 weeks or longer (Cochrane, Bellamy, 2006).

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OSTEOARTHRITIS KNEE

• Viscosupplementation Strong evidence in knee
  osteoarthritis, the effectiveness of
  viscosupplementation may impose a risk of adverse
  events on the patient (Rutjes, 2012, AAOS).

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OSTEOARTHRITIS KNEE

• Aggravated Osteoarthritis (OA) lifetime risk
  for symptomatic knee arthritis is around 45 and
  is higher among obese persons (Murphy, 2008).
• Radiographic findings do not correlate well with
  clinical symptoms (Barker, 2004 Link, 2003).
• Although functional loss is common over time,
  approximately 30 of patients improve (Dekker,
  2009).

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OSTEOARTHRITIS KNEE CAUSATION

• Occupational Relationship Relationship to work
  activities including but not limited to physical
  activities such as repetitive kneeling or
  crawling, squatting and climbing, or heavy
  lifting.
• Good evidence - intensive physical
• work more than doubles the risk of
• symptomatic knee OA with knee
• replacement, and that there is a
• dose-response relationship between work load and
  the development of knee OA with knee replacement.

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OSTEOARTHRITIS KNEE CAUSATION

• Intensive physical labor - job categories such as
  forestry employee, dockworker, farm workers, or
  ditch digger (Apold, 2014).
• Non-occupational Risk Factors Body mass index
  (BMI) of gt 25 a significant risk factor for
  eventual knee replacement.
• Good evidence obesity increases the risk of
  symptomatic knee OA resulting in knee replacement
  6X in men and 11X in women (Apold, 2014).

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OSTEOARTHRITIS KNEE CAUSATION

• Strong evidence for hand OA as a significant
  marker of risk by knee OA (Blagojevic, 2010).
• Other causative factors to consider Strong
  evidence that an ACL injury increased the
  ten-year risk of developing Kellgren-Lawrence
  defined osteoarthritis changes compared to the
  uninjured knee.

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OSTEOARTHRITIS KNEE CAUSATION

• Good evidence meniscal damage, even in the
  absence of knee surgery is associated with
  significantly increased risk of development of
  radiographic tibiofemoral OA within 30 months of
  its detection on MRI (Englund, 2009).
• Strong evidence for previous knee injury as a
  significant risk factor for OA (Blagojevic, 2010).

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OSTEOARTHRITIS KNEE CAUSATION

• range from approximately 25 to 50. Unclear
  whether the repair of ACLs significantly
  decreases the degenerative pathology (Neuman,
  2008, 2009 Eckstein, 2015 Brophy 2014
  Barenius, 2014 Oiestad 2011 Ajuied, 2014
  Claes, 2013).
• Patient should have medical documentation of the
  following
• Menisectomy hemarthrosis at the time of the
  original injury.
• Evidence of MRI or arthroscopic meniscus of ACL
  damage.

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OSTEOARTHRITIS KNEE CAUSATION

• Prior injury should be at least 2 years from the
  presentation for the new complaints.
• There should be a significant increase of
  pathology on the affected side in comparison to
  the original imaging or operative reports and/or
  opposite un-injured side or extremity (Eckstein,
  2015).