Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears Part 6

Conclusions

For the majority of interventions, only sparse data are available, precluding firm conclusions for any single approach or for the optimal overall management of this condition. The paucity of evidence related to early versus delayed surgery is of particular concern, as patients and providers must decide whether to attempt initial nonoperative management or proceed immediately with surgical repair. The majority of the data is derived from studies of low methodological quality or from study designs associated with higher risk of bias

(e.g., observational and before-and-after studies). Overall, the evidence shows that all interventions result in substantial improvements; however, few differences of clinical importance are evident when comparisons between interventions are available. Complication rates were generally low and the majority of complications were not deemed to be clinically important; therefore, the benefit of receiving treatment for rotator cuff tears appears to outweigh the risk of associated harms. Future research is needed to determine the relative effectiveness of rotator cuff treatment options.

Source: Summary of strength of evidence for nonoperative and operative interventions for RC tears

Table of Contents

Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears

• Introduction


• Key Questions


• Methods


• Results


• Future Research


• Conclusions

        

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Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears Part 5

Future Research

Recommendations for further research:

• Primary evidence is needed, comparing the effectiveness of early versus delayed surgery, nonoperative versus operative interventions, and among the nonoperative treatment options. Future research examining the comparative effectiveness of open, mini-open, or arthroscopic approaches is also a priority, as arthroscopic procedures are more costly and technically difficult.


• All future studies should employ a comparison or control group and should ensure comparability of treatment groups, optimally through the use of randomization.


• Future research should seek to minimize bias by blinding outcome assessors, using validated and standardized outcome assessment instruments, and ensuring adequate allocation concealment (where applicable) and the appropriate handling and reporting of missing data.


• Studies examining the long-term effectiveness of treatments over the course of several years are needed; at the very least, studies should follow patients for a minimum of 12 months.


• To avoid numerous studies on disparate interventions, the interventions and comparisons chosen for study should be guided by consensus regarding the most promising and/or controversial interventions.


• To ensure consistency and comparability across future studies, consensus is needed on outcomes that are important to both clinicians and patients. Moreover, consensus on minimal clinically important differences is needed to guide study design and interpretation of results.


• To permit the appropriate interpretation of results, future research needs to be reported in a consistent and comprehensive manner.
  
  

Source: Summary of strength of evidence for nonoperative and operative interventions for RC tears

Table of Contents

Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears

• Introduction


• Key Questions


• Methods


• Results


• Future Research


• Conclusions

        

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Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears Part 3

Methods

Literature Search

The following bibliographic databases were searched systematically for studies published between 1990 and 2009: Medline®, Embase, Evidence-Based Medicine Reviews – The Cochrane Library, AMED, Cumulative Index to Nursing and Allied Health Literature (CINAHL), SPORTDiscus with Full Text, Academic Search Elite, Health Source, Science Citation Index Expanded (via Web of Science®), Scopus®, BIOSIS Previews®, and PubMed. Additional searches of the Grey Literature were conducted in Conference Papers Index, Computer Retrieval of Information on Scientific Projects (CRISP), Scopus®, as well as government Web sites by the U.S. Food and Drug Administration and Health Canada. Databases that yielded included studies (Medline®, Embase, Central, and CINAHL®) were searched again in September 2009 to identify recently published studies. Hand searches were conducted to identify literature from symposia proceedings from the following scientific meetings: Arthroscopy Association of North America (2007-2009), American Academy of Orthopaedic Surgeons (2007-2009), American Physical Therapy Association (2006-2008), American Shoulder and Elbow Surgeons (2005-2008), American Society of Shoulder and Elbow Therapists (2004-2008), European Congress of Physical and Rehabilitation Medicine 2008, Congress of the European Society for Surgery of the Shoulder and the Elbow (2009), and the Mid-America Orthopaedic Association (2006-2008). Ongoing studies were identified by searching clinical trials registers and by contacting experts in the field. Reference lists of relevant reviews were searched to identify additional studies. No language restrictions were applied.

Study Selection

Two reviewers independently screened titles and abstracts using general inclusion criteria. The full text publication of all articles identified as “include” or “unclear” were retrieved for formal review. Each full-text article was assessed independently by two reviewers using detailed a priori inclusion criteria and a standardized form. Disagreements were resolved by consensus or by third-party adjudication.

Controlled and prospective uncontrolled studies were included in the review if they were published in 1990 or later, included a minimum of 11 participants, focused on adults with a partial or full-thickness tear that was confirmed by imaging or intraoperative findings, and examined any operative or nonoperative intervention or postoperative rehabilitation. In addition, studies were required to report on at least one outcome of interest (quality of life, function, time to return to work, cuff integrity, pain, range of motion, and/or strength) and have a minimum followup duration of 12 months for operative studies. For the review update, only controlled studies were included.

Quality Assessment and Rating of the Body of Evidence

Two reviewers independently assessed the methodological quality of included studies. The Cochrane Collaboration’s “risk of bias” tool was used to assess randomized controlled trials and controlled clinical trials. Observational analytic studies were assessed using modified cohort and case-control Newcastle-Ottawa Quality Assessment Scales. The methodological quality of uncontrolled studies was assessed using a quality checklist developed by the University of Alberta Evidence-based Practice Center; the checklist consisted of three items: consecutive enrollment, incomplete outcome data, and standardized/independent approach to outcome assessment. In addition, the source of funding was recorded for all studies.

The body of evidence was rated by one reviewer using the EPC GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. The strength of evidence was assessed for four key outcomes considered by the clinical investigators to be most clinically relevant: health-related quality of life, functional outcomes, time to return to work, and cuff integrity. The following four major domains were assessed: risk of bias (low, medium, high), consistency (no inconsistency, inconsistency present, unknown, or not applicable), directness (direct, indirect), and precision (precise, imprecise).

Data Extraction

Data were extracted by one reviewer using a standardized form and verified for accuracy and completeness by a second reviewer. Extracted data included study characteristics, inclusion/exclusion criteria, participant characteristics, interventions, and outcomes. Reviewers resolved discrepancies by consensus or in consultation with a third party.

Data Analysis

Evidence tables and qualitative descriptions of results were presented for all included studies. Comparative studies were considered appropriate to combine in a meta-analysis if the study design, study population, interventions being compared, and outcomes were deemed sufficiently similar. Results were combined using random effects models. Statistical heterogeneity was quantified using the I-squared (I²) statistic. Graphs were created to display the preoperative and postoperative scores of uncontrolled studies, cohort studies, and trials over the duration of the study followup period.

Source: Summary of strength of evidence for nonoperative and operative interventions for RC tears

Table of Contents

Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears

• Introduction


• Key Questions


• Methods


• Results


• Future Research


• Conclusions

        

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Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears

Introduction

The rotator cuff (RC) is comprised of four muscle-tendon units, which stabilize the humeral head within the shoulder joint and aid in powering the movement of the upper extremity.1 RC tears refer to a partial or full discontinuation of one or more of the muscles or tendons and may occur as a result of traumatic injury or degeneration over a period of years. The incidence of RC tears is related to increasing age; 54 percent of patients over the age of 60 years have a partial or complete RC tear compared with only 4 percent of adults under 40 years of age.2 Although not a life-threatening condition, RC tears may cause significant pain, weakness, and limitation of motion.1

Both nonoperative and operative treatments are used in an attempt to relieve pain and restore movement and function of the shoulder.3 The majority of patients first undergo 6 weeks to 3 months of nonoperative treatment, which may consist of any combination of pain management (medications and injections), rest from activity, passive and active exercise, and treatments with heat, cold or ultrasound. Failing nonoperative treatment, the cuff may be surgically repaired using an open, mini-open, or all-arthroscopic approach. A variety of postoperative rehabilitation programs are used to restore range of motion, muscle strength, and function following operative treatment.

Earlier operative treatment has been proposed to improve patient outcomes and result in an earlier return to work, and decreased costs;4,5 therefore, patients and clinicians face the difficult decision of when to forgo attempts at nonoperative treatment in favor of operative treatment. Moreover, the comparative effectiveness of the various nonoperative and operative treatment options for patients with RC tears remains uncertain.
Source: Summary of strength of evidence for nonoperative and operative interventions for RC tears

Table of Contents

Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears

• Introduction


• Key Questions


• Methods


• Results


• Future Research


• Conclusions

        

Read More