Sipola 2010.

Clinical features and settings	Inclusion criteria: Participants with acute or chronic shoulder pain and suspicion of rotator cuff tears Patients who had undergone conservative treatment without sufficient symptom relief Exclusion criteria: Time elapsed between index test and reference standard was more than 12 months Duration of symptoms (pain): mean 21 months (range 2 to 144 months Previous treatments: Conservative treatment including physiotherapy for at least 3 months Care setting: Tertiary or secondary
Participants	Place of study: Kuopio, Finland Period of study: Not reported Number of participants eligible: 79 participants Number of participants enrolled IT and RS: ‐ MRA and arthroscopy or open surgery: 75 participants ‐ US and arthroscopy or open surgery: 77 participants Data available for analyses: ‐ MRA and arthroscopy or open surgery: 75 participants ‐ US and arthroscopy or open surgery: 77 participants Age: mean 57 years (range 42 to 76 years) Male/Female: 40/37 Dominant arm: Not reported Nature of onset: The etiology of suspected tear was traumatic in 22% and degenerative in 78% of the participants
Study design	Primary objective: To compare the accuracy of US and MRA for the detection and measurement of rotator cuff tears using surgical findings as the standard in a prospective study setting Study design: Prospective, consecutive, accuracy cohort study with fully paired direct comparison between MRA and 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 mini‐open ‐ Description of technique: Not reported ‐ Criteria for a positive result: The size and type (partial/full thickness) of tendon tear was determined and measured from anterior to posterior and from lateral to medial dimensions A sterile ruler or a calibrated arthroscopic probe was used to define both the anteroposterior and the mediolateral size of the tear
Index and comparator tests	Index test(s): MRA and US ‐ Description of technique: MRA MRI unit: 1.5 T scanner equipped with a flexible surface coil Sequences and Planes: Oblique coronal T1‐weighted spin‐echo (TR/TE 650/20); a T2‐weighted fat‐saturated dual‐echo fast spin‐echo (FSE), 3500/16; oblique sagittal T2‐weighted dual‐echo FSE, 3500/16, 98; axial T2*‐weighted gradient echo two‐dimensional FLASH, 580/15, flip angle 15o; a T1‐weighted fat‐saturated SE, 800/20; T1‐weighted fat‐saturated spin‐echo 800/20 images in the sagittal oblique, coronal oblique and axial planes, and T2‐weighted FSE 4500/96 images in the coronal oblique plane Contrast and procedure: 10 to 20 mL of gadopentetate dimeglumine in a concentration of 469.01 mg/mL was diluted in 250 mL of saline The procedure involved direct intra‐articular injection Patient position: Not reported Seven participants underwent to MRI only (without an intra‐articular contrast) US Scanner: 7.5 MHz linear‐array transducers in real‐time Technique: Images were obtained on the long and short axes of the tendon Patient position: The subscapularis tendon was evaluated with the forearm rotated externally The supraspinatus tendon was assessed with the arm on the ipsilateral side The supraspinatus was assessed with the hand behind the patient’s back (Crass position) or on the waist (modified Crass position) (Crass 1987; Ferri 2005) The infraspinatus tendon was assessed with the patient placed the ipsilateral hand across the chest on top of the contralateral shoulder ‐ Criteria for a positive result: MRA: Full thickness tears: the contrast agent was detected on the MR image throughout the full thickness of the rotator cuff and/or when the contrast agent was detected in the subacromial bursa Partial thickness tears: the contrast agent entered the cuff substance without reaching the subacromial bursa US: Full thickness tears: hypoechoic area or volume loss extended from the bursal surface to the articular surface of the tendon Otherwise the tear was diagnosed as a partial thickness tear ‐ Time from symptoms to index test: mean 21 months (range 2 to 144 months ‐ Time from MRA and US: in the same day ‐ Time from index test to reference standard: mean 2.3 months (range 0 to 9.5 months)
Follow‐up	Adverse events due to index test(s): Of the 77 patients, two (3%) could not undergo MRA due to claustrophobia Adverse events due to reference standard test(s): Not reported
Notes	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 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 2.3 months
Partial verification avoided? All tests	Yes	Only two patients (2.5%) were excluded of study because of delay in surgery 12 months due to medical illness
Differential verification avoided? All tests	No	The choice of reference standard (arthroscopy or open surgery) varied between individuals
Incorporation avoided? All tests	Yes	The index test did not form part of the reference standard
Index test results blinded? All tests	Unclear	Insufficient information was given to permit judgement
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	The number and reasons of all withdrawals from the study were explained
Learning curve / training reported of index test? All tests	Yes	The interpreter of MRA was a radiologist who had 1 year of experience in musculoskeletal MRI at the beginning of the study The interpreters of US were three radiologists each with more than 10 years experience in shoulder US
Learning curve / training reported of reference standard? All tests	Unclear	The reference standards were performed by three experienced orthopaedic surgeons Training and expertise were not described
Index test criteria for a positive test result reported? All tests	Yes	The study reported the definition of a positive index test result