Teefey 2004.
Clinical features and settings |
Inclusion criteria: Acute or chronic shoulder pain accompanied by a high clinical suspicion of rotator cuff disease Exclusion criteria: Participants with severe claustrophobia, which is a contraindication for magnetic resonance imaging; a previous operation on the shoulder; a humeral fracture; and inflammatory arthritis Duration of symptoms: Not reported Previous treatments: Not reported Care setting: Not reported, probable tertiary or secondary |
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Participants |
Place of study: St. Louis, Missouri, USA Period of study: December 1998 and April 2001 Number of participants eligible: 130 participants Number of participants enrolled IT and RS: ‐ MRI and arthroscopy: 71 shoulders ‐ US and arthroscopy: 71 shoulders Data available for analyses: ‐ MRI and arthroscopy: 71 shoulders ‐ US and arthroscopy: 71 shoulders Age: mean 59 (range 31 to 80 years) Male/Female: 41/30 Dominant arm: Not reported Nature of onset: Not reported |
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Study design |
Primary objective: To compare the diagnostic performances of US and MRI for both the detection of a rotator cuff tear and the quantification of its size, with use of arthroscopic findings as the standard Study design: Prospective, consecutive, accuracy cohort study with fully paired direct comparison between US and MRI Language: English |
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Target condition and reference standard(s) |
Target conditions: Presence of any rotator cuff tears, full thickness tears and partial thickness tears Reference standard(s): Shoulder arthroscopy ‐ Description of technique: The rotator cuff was examined from both the articular and the bursal side. A tagged suture (number‐1 PDS [polydioxanone]) was placed, during intra‐articular viewing, through the suspected region of the cuff tear to guide arthroscopic bursal imaging ‐ Criteria for a positive result: The presence or absence of a rotator cuff tear and the size and extent of the tear, when present, were recorded. Specifically, the presence or absence of a full thickness tear or of a bursal or articular‐side partial thickness tear and the width (perpendicular to the long axis of the cuff fibres) of any tear that was found were recorded |
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Index and comparator tests |
Index test(s): MRI and US ‐ Description of technique: MRI MRI unit: 1.5 T with high field strength with a two‐piece shoulder array coil (54 participants); and with flexible local coils (17 participants) Sequences: Fat‐suppressed, fast‐spin‐echo, proton‐density‐weighted, spin‐echo, or fast‐spin‐echo and transverse, T2‐weighted, fast‐spin‐echo images with or without fat suppression Planes: Oblique coronal and oblique sagittal Patient position: Not reported US Scanner: 7.5 to 9 MHz linear‐array transducer in real‐time Technique and Patient position: As previously described (Teefey 2000). ‐ Criteria for a positive result: MRI: Full thickness tears: complete disruption of all tendon fibres or when the signal within the cuff tendons was isointense compared with fluid on the T2‐weighted images and extended from the articular to the bursal surface on one or more images. Partial thickness tears: fluid‐intensity signal within the tendons was in contact with only one of the surfaces US: Full thickness tears: non‐visualisation of rotator cuff or a focal defect in the rotator cuff created by a variable degree of retraction of the torn tendon ends. Partial thickness tears: minimal flattening of the bursal side of the rotator cuff (bursal‐side tear) or a distinct hypoechoic or mixed hyperechoic and hypoechoic defect visualized in both the longitudinal and the transverse plane at the deep articular side of the rotator cuff (articular‐side tear) ‐ Time from symptoms to index test: Not reported ‐ Time from US and MRI: MRI was performed on the same day as the US for all but three patients, two of whom had the studies six days apart and one of whom had them one day apart ‐ Time from index test to reference standard: mean 56 days (range 2 to 190 days) |
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Follow‐up |
Adverse events due to index test(s): Not reported Adverse events due to reference standard test(s): Not reported |
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Notes | Part of population (only the participants with full thickness rotator cuff tears) of this study was also reported in Teefey 2005 A two‐by‐two table of the ITs and RS was given, which tallied with the reported summary data with a few discrepancy |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Unclear | Insufficient information was given to permit judgement |
Acceptable reference standard? All tests | Yes | The reference standard was arthroscopy and the target condition were presence of any rotator cuff tears, full thickness tears and partial thickness tears |
Acceptable delay between tests? All tests | No | The average interval between reference standard and index test was 56 days |
Partial verification avoided? All tests | No | Not all the patients who received the index test underwent a reference standard to verify their true disease status Of the 130 eligible participants 71 underwent to reference standard |
Differential verification avoided? All tests | No | The result of the index test probably influenced the choice of the reference standard |
Incorporation avoided? All tests | Yes | The index test did not form part of the reference standard |
Index test results blinded? All tests | Yes | The person undertaking the index test was blinded to the results of the standard reference |
Reference standard results blinded? All tests | No | The results of the index tests were known to the person interpreting the reference tests |
Relevant clinical information? All tests | Unclear | Not reported |
Uninterpretable results reported? All tests | Unclear | Insufficient information was given to permit judgement |
Withdrawals explained? All tests | No | Some of the eligible patients who entered the study did not complete it and these patients were not accounted for |
Learning curve / training reported of index test? All tests | Yes | The interpreter of MRI was one of six radiologists with extensive experience in musculoskeletal magnetic resonance imaging The interpreter of US was one of two radiologists who were very experienced with the technique and who had conducted more than 2500 examinations during a 10‐year period |
Learning curve / training reported of reference standard? All tests | Unclear | The reference standards were performed by an experienced orthopaedic surgeon |
Index test criteria for a positive test result reported? All tests | Yes | The study reported the definition of a positive index test result |