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. 2013 Sep 24;2013(9):CD009020. doi: 10.1002/14651858.CD009020.pub2

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
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
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
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
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
Follow‐up Adverse events due to index test(s): Not reported
Adverse events due to reference standard test(s): Not reported
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
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