Swen 1999.
Clinical features and settings |
Inclusion criteria: Patients awaiting surgery because of a clinically suspected rotator cuff tears The clinical diagnosis of rotator cuff tears was based on marked difficulty in initiating abduction of the arm with weakness and limitation of movement Lidocaine was injected below the acromion, if after the injection the strength of the rotator cuff was still decreased; this was considered to indicate rotator cuff tears Exclusion criteria: Patients with neurologic origins of the weakness Duration of symptoms: mean 2.3 years (range 0.3 to 8 years) Previous treatments: Not reported Care setting: Not reported Probably tertiary or secondary |
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Participants |
Place of study: The Netherlands Period of study: Not reported Number of participants eligible: 21 participants Number of participants enrolled IT and RS: ‐ MRI and arthroscopy: 21 participants ‐ US and arthroscopy: 21 participants Data available for analyses: ‐ MRI and arthroscopy: 21 participants ‐ US and arthroscopy: 21 participants Age (mean/SD): 54/12 years Male/Female: 12/9 Dominant arm: Not reported Nature of onset: In four patients the shoulder complaints could be attributed to trauma |
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Study design |
Primary objective: To evaluate the ability of US and MRI to detect full thickness rotator cuff tears in patients with a clinically suspected rotator cuff tears as a solitary non‐inflammatory condition Study design: Prospective, consecutive, accuracy cohort study with fully paired direct comparison between MRI and US Language: English |
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Target condition and reference standard(s) |
Target conditions: Presence full thickness tears Reference standard(s): Shoulder arthroscopy ‐ Description of technique: First the arthroscope was introduced in the glenohumeral joint and then into the subacromial space After introducing the scope into the subacromial space, the bursa was removed to enable examination of the bursal side of the cuff ‐ Criteria for a positive result: A full‐thickness was diagnosed if free communication was found between the bursal and humeral sides of the cuff |
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Index and comparator tests |
Index test(s): MRI and US ‐ Description of technique: MRI MRI unit: 1.0T system with a dedicated shoulder coil as receiver Sequences: T1‐weighted (TR/TE 680/15) and a standard T2 coronal spin‐echo sequence (TR/TE 3000/15,105 ms) Planes: Oblique coronal Patient position: Supine position US Scanner: 7.5 MHz linear array and the 5.0 MHz curved array transducers Technique: The shoulder was examined in the anterior, lateral, and posterior directions, in both the transverse and the longitudinal planes as described by Van Holsbeeck 1991 Patient position: The patients were seated For the anterior approach, the patient’s upper arm was visualised in internal rotation, which was achieved by placing the patient’s hand behind the back ‐ Criteria for a positive result: MRI: Full‐thickness tears: a focal, well‐defined area of increased signal intensity on T1‐weighted and T2‐weighted images that extended through the entire thickness of the tendon US: Full‐thickness tears: a discontinuity in the rotator cuff, extending from the bursal to the humeral side of the rotator cuff ‐ Time from symptoms to index test: Not reported ‐ Time from Conventional MRA and 3D isotropic MRA: Not reported ‐ Time from index test to reference standard: MRI and US were performed within 3 weeks before surgery |
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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 | The results of index test were interpreted by two experienced musculoskeletal radiologists The data of only one reader (reader 1) were arbitrarily chosen to be included in our analyses Raw data were given and it was possible to back‐calculate this from the reported summary data |
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Table of Methodological Quality | ||
Item | Authors' judgement | Description |
Representative spectrum? All tests | Yes | Tertiary or secondary care, participants with suspected of having any rotator cuff tears The study was prospective and recruitment was consecutive |
Acceptable reference standard? All tests | Yes | The reference standard was arthroscopy and the target condition was presence of full thickness tears |
Acceptable delay between tests? All tests | Yes | The index tests were performed within 3 weeks of surgery |
Partial verification avoided? All tests | Yes | All patients who received the index test went on to receive verification of their disease status using a reference standard |
Differential verification avoided? All tests | Yes | All patients received the same reference standard, regardless of the result of their index test |
Incorporation avoided? All tests | Yes | The index test did not form part of the reference standard |
Index test results blinded? All tests | Yes | The study was prospective and the results of the index tests were interpreted before the reference standard |
Reference standard results blinded? All tests | Unclear | Insufficient information was given to permit judgement |
Relevant clinical information? All tests | No | The interpreters were blinded to history and physical examination |
Uninterpretable results reported? All tests | Yes | The study was prospective, recruitment was consecutive and results were reported for all initially included participants |
Withdrawals explained? All tests | Yes | No participants were excluded from the analysis |
Learning curve / training reported of index test? All tests | Unclear | A rheumatologist and a radiologist, both experienced with this test In fact they had different results but this was not examined in this study |
Learning curve / training reported of reference standard? All tests | Unclear | The reference standards were performed by a single experienced surgeon |
Index test criteria for a positive test result reported? All tests | Yes | The study reported the definition of a positive index test result |