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Butler M, Forte M, Braman J, et al. Nonoperative and Operative Treatments for Rotator Cuff Tears: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 22 [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Feb. (Future Research Needs Papers, No. 39.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Nonoperative and Operative Treatments for Rotator Cuff Tears: Future Research Needs: Identification of Future Research Needs From Comparative Effectiveness Review No. 22 [Internet].

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Appendix FMinnesota Evidence-based Practice Center Rotator Cuff Research Needs Project: Stakeholder Conference Call Summary, September 23 to October 24, 2011

Purpose of the Meetings

  • To solicit feedback from stakeholders on a list of research knowledge gaps in rotator cuff tear outcomes which need to be addressed in order to fully answer the key research questions posed in the EPC report “Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears.”

Research Knowledge Gaps to add or differentiate in the MN EPC list

The discussion was initially guided by the research gaps identified in the EPC report and the list provided by the MN EPC. Some points were elaborations of gaps already noted. Others are new gaps.

Methodological questions

Measurement

  • Need clear and consistent definitions (terms) for rotator cuff pathology across providers and imaging reports, including terms for concomitant pathology. Clinicians need to know what is being treated before choosing or comparing treatments.
  • Define “cuff integrity” for pre/nonoperative and postoperative patients
  • Diagnostic imaging (ultrasound, MRI, CT arthrogram)
    • Tear classification/cuff integrity: which modality and who should interpret it?
    • As outcome measure: what is reliable in the postoperative setting?
  • Need agreement on core toolkit of outcomes measures to use across studies with the ability to add additional measures based on specific patient populations and research questions.

Design and Reporting

  • Clear description of treatments.
  • Baseline patient differences need better identification/differentiation in studies
  • Clinical trial design issues:
    • Questions related to prognosis are best addressed with prospective observational studies; need sufficient sample size for subgroup analysis
    • Patient classification: should it be pathology or functional limitation/impairment based? Tear age considerations?
  • Registry needed to accrue large number of patients: baseline factors, natural history, outcomes
  • Design should be geared toward generalizability: pre/post treatment with concurrent controls, 10–15 year followup
  • Reporting: What pathology is being treated with specific therapies or intraoperative procedures (such as intra-articular hyaluronic acid; stem cells, electrocautery of the joint capsule, etc.)

Scientific questions

The major questions/areas of stakeholder interest that motivated the majority of the discussions were:

  • Who needs surgery?
  • What treatments help, and in what order? (nonoperative, operative)
  • What are the predictive factors - patient, pathology, treatment goals that should guide treatment decisions?
  • What is the natural history of rotator cuff tears?
  • What is the value of adjunctive care (e.g., rehabilitation)?

Additional scientific questions included:

  • (Once pathology definitions are clear), what is the benchmark or threshold for surgery, given the rotator cuff tear severity/grade? How does concomitant pathology or patient age modify a surgical threshold? Who does best non-operatively?
  • Identify optimal nonoperative rehabilitative protocol(s) for stabilization around rotator cuff tear.
  • Worker’s compensation patients: What treatment/rehabilitation and when?
  • Operative decision timing: What needs to be repaired right away?
  • Nonoperative treatment comparisons, including:
    • supervised versus home program
    • impact of range of motion (ROM) and strength on outcomes
  • Post-operative rehabilitation:
    • What to do and when to do it
    • What is the role of CPM (continuous passive motion)?
    • How does the timing of passive→active→resistive exercise impact tissue healing?
  • Impact of psychological factors on outcomes: fear-avoidance, coping mechanisms
  • Does cuff integrity (yet to be defined) predict patient-centered outcomes (often ‘good outcome’ but poor strength)?
  • Natural history studies of (nonoperative) rotator cuff tears, given patient and tear factors.
  • Patient populations differ: sports, worker’s compensation, elderly.

Items needing consensus (not classified above)

  • Indications for imaging of the rotator cuff (initial)
  • Post-operative imaging: When is it indicated and which imaging?
  • Is a multidisciplinary guideline or standard of care attainable?
    • No standard of care for rotator cuff tears; therefore, patients don’t know which provider to see first. Treatment (and imaging) track is determined by the type of provider a patient sees first and individual provider preferences (conservative versus other).

What Gaps could be culled prior to ranking process

  • Surgical technique comparisons: Not as important as understanding which patients should receive which treatment within broad classifications (surgery or nonoperative).
  • Biologics/PRP: not ready to be studied yet. The bigger issue is when surgery is indicated. Perhaps the “additional databases,” last item under design and reporting issues.
  • Massage therapy? Unclear on the role of massage therapy in rotator cuff recovery.

Consumer points

  • The primary outcome interest is in restoration of full function.
  • Like other conditions, provider training, perspective and location are what determine which treatment a patient will receive, especially for conditions like rotator cuff where there is uncertainty among providers about which treatment is best under what circumstances. Therefore, who (which provider) a patient sees first will determine which course of treatment and/or diagnostic imaging a patient will receive. How does a patient determine who to see first? Most consumers don’t know where to start.
  • Consumers want to know treatment options based on their condition, not solely based on what providers want to do. If both nonsurgical and surgical options are practical, consumers want to know them so they can make a choice. Consumers suggest that patients may not be given choices because of provider preferences.
  • There is great variability in diagnoses and care of rotator cuff problems.
  • Shoulders are complex. Misdiagnoses are common across many types of providers: (primary care, physical therapy, radiology (misreads) and orthopedic surgeons (general). Serial misdiagnoses occur.
  • Improper therapy (after misdiagnosis or accurate diagnosis) can cause patients extended pain and delay effective treatment, perhaps even limiting their options for effective treatment because of such delays.
  • Provider expertise: Individuals with shoulder injuries should see a shoulder specialist first to get an accurate diagnosis and appropriate treatment plan that takes patient preferences into consideration. That is opposite how the system currently works. Consumers want to be evaluated by clinicians who can conduct a thorough shoulder-specific clinical exam to reach a diagnosis, not a generalist. Advanced imaging should not replace a good clinical exam. Radiologists/others who read advanced shoulder imaging studies should be trained specifically in shoulder. Surgeons who operate on rotator cuff tears should have additional training in shoulder; general orthopedic surgeons who are not experts may have worse outcomes than orthopedic shoulder surgeons.
  • Consumers want to know how to determine how good a provider is.
  • There is a lack of public understanding of which rotator cuff injuries really need surgery.
  • Care coordination between different types of providers is often poor, particularly if providers are at different sites.

General Discussion Points

  • Very important topic. Second only to spine.
  • A common discussion point was the importance of understanding the factors that contribute to an appropriate and effective treatment decision. What is needed for a definitive diagnosis? Is there a way to establish benchmarks that help the diagnosis process? What patient factors matter?
  • Different major patient populations – sports injury versus workers compensation versus older patient and chronic tears.
  • Terminology matters. Who is describing the pathology influences how the pathology is described? Different disciplines bring different perspectives to bear and use even common language in different ways. For example, a primary care physician orders imaging, the pathology is described by a radiologist. Pathology descriptions by orthopedic surgeons or rehabilitation providers may differ.

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