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The Myth Busters: Evidenced-Based Guidelines in Practice Kathryn Mueller, MD,MPH Medical Director , DOWC Professor, Schools of Medicine and Public Health. Disclaimers. Scientific Advisory Committee and Consultant – Workers Compensation Research Institute
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The Myth Busters:Evidenced-Based Guidelines in PracticeKathryn Mueller, MD,MPHMedical Director , DOWCProfessor, Schools of Medicine and Public Health
Disclaimers Scientific Advisory Committee and Consultant – Workers Compensation Research Institute International Scientific Advisory Board – MedRisk Regular Speaker for American Board of Independent Medical Examiners
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
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
#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 intervention’s 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 *****
Consensus Values Functional benefit to patient (pain relief not enough) Acceptable risk and morbidity Length of disability and timeframe to recovery Acceptable cost
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
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, P<.001). Based on observational studies 3.49 CI, 1.45-8.41;P=.005).
LOWER EXTREMITY INJURY MEDICAL TREATMENT GUIDELINES Colorado 2015 Bibliography – 582 Critiques - 216
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
Achille’s tendon Complete Rupture Requires a surgical repair True or False
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.
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
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
Injections – Diagnostic Epidural Steroid Injections (ESIs) • Strong evidence epidural steroid injections have a smallaverage 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).
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)
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.
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
Smidt, Nynke et al. Corticosteroid injections, physiotherapy, or a wait-and-see policy for lateral epicondylitis: a randomised controlled trial. Lancet, February 23, 2002; 359:657-662. Cortisone efficacy for epicondylitis treatment
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)
ClinicalCase 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.
ClinicalCase Past History • No other health issues. • Historically he was an avid skier and mountain biker however, he denies any injuries to his shoulder.
ClinicalCase P.E. Right shoulder – normal exam Left shoulder – Drop arm – negative Hawkins – painful Neer – positive Jobe Empty can – positive ROM – very painful 60-120⁰ Vascular, sensation & neck exam - normal
Questions • Are any imaging tests needed? • What should initial treatment be? • When should injections be considered? • When should surgery be considered?
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)
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.
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)
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).
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).
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
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
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.
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.
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).
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.
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
How about meniscus tears? In a patient without locking what are the considerations for surgery?
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).
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.
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).
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.
MENISCUS INJURY Arthroscopic meniscotomy is not superior to the sham diagnostic procedure which leaves the meniscus intact (Sihvonen, 2013). Strong evidencepartial meniscotomy provides no clear benefit over initial exercise therapy for patients with an isolated degenerative meniscal tear. Therefore, is not recommended.
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
Clear ACL Tear Should surgery be scheduled for all cases? What are the considerations?
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.
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.
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 ineffectivefor relieving pain in patients with knee or hip OA (Wu, 2013).
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).
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).
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).