Wallny 2001.
Clinical features and settings |
Inclusion criteria: Participants suffering from shoulder pain with histories and physical examinations suggestive of rotator cuff lesions Exclusion criteria: Participants with prior shoulder surgery or previous fracture of the humeral head Duration of symptoms: Not reported Previous treatments: Not reported Care setting: Tertiary or secondary |
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Participants |
Place of study: Bonn, Germany Period of study: Not reported Number of participants eligible: 40 participants Number of participants enrolled IT and RS: ‐ Two‐dimensional (2D) US and arthroscopy or open surgery: 40 participants ‐ Tree‐dimensional (3D) US and arthroscopy or open surgery: 40 participants Data available for analyses: ‐ 2D US and arthroscopy or open surgery: 40 participants ‐ 3D US and arthroscopy or open surgery: 40 participants Age: mean 54 years (range 38 to 79 years) Male/Female: 25/15 Dominant arm: Not reported Nature of onset: Not reported |
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Study design |
Primary objective: To determine the validity of 3D US in the diagnosis of rotator cuff lesions Study design: Prospective, consecutive, accuracy cohort study with fully paired direct comparison between 3D US and 2D US 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 or open surgery ‐ Description of technique: Not reported ‐ Criteria for a positive result: Not reported |
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Index and comparator tests |
Index test(s): 3‐D US and 2‐D US ‐ Description of technique: Scanner: 10 MHz electronic linear array in broad bandwidth technology, 192 fine pitch elements, frequency ranges: resolution: 4.5 to 13 MHz, penetration: 2.5 to 10 MHz Technique and Patient position: Not reported The region of interest was defined by 2D US before 3D US could be undertaken ‐ Criteria for a positive result: Full thickness tear was defined as: marked thinning, sudden changes of calibre, hyper‐ and/or hypoechoic zones and total absence of the cuff Partial thickness tear was defined as: constituting no more than loss of 1/4 to 1/2 of full thickness of the intact rotator cuff ‐ Time from symptoms to index test: Not reported ‐ Time from 2D US and 3D US: in the same examination ‐ Time from index test to reference standard: Not reported |
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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 study reported that the target conditions were presence of any rotator cuff tears, full thickness tears and partial thickness tears Only the data for analysing presence of any rotator cuff tears were available The study reported the data of two different types of US (three‐dimensional and two‐dimensional) Inasmuch as the 2D US examinations are more often used in clinical practice we arbitrarily chose 2D US to be included in our analyses A two‐by‐two table of the ITs and RS was given which tallied with 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 | Unclear | The reference standard was arthroscopy or open surgery and the target conditions were presence of full thickness tears and partial thickness tears |
Acceptable delay between tests? All tests | Unclear | The study did not report the time elapsed between the index tests and reference standard |
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 | The indication for surgery was based on the results of clinical assessment and an MRI scan but independent of the result of the 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 | Unclear | Not reported |
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 | Insufficient information was given to permit judgement |
Learning curve / training reported of reference standard? All tests | Unclear | The reference standards were performed by a single 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 |