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
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