Michener, 2009

Type of study:

Diagnostic test accuracy study (prospective, blinded study design)

Setting and country:

Orthopedic surgeon shoulder clinic

Funding and conflicts of interest:

No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated.

Inclusion criteria:

- Consecutive patients presenting with shoulder pain to an orthopedic surgeon’s office

- patients had to report shoulder pain for at least 1 week, and shoulder pain had to be their primary complaint.

Exclusion criteria:

Not reported.

Characteristics

N=55 patients

Age,mean ± SD (range): 40.6 ± 15.1 years (range 18–83y)

Sex: 47 M/8 F

Average symptom duration 33.8 ± 48.9 months (range 2-230 months)

5 shoulder tests were compared to each other:

Neer, Hawkins-Kennedy, painful arc, empty can (Jobe), and external rotation resistance test.

Neer test: the Neer test was performed with the examiner stabilizing the scapula with a downward force while fully flexing the humerus overhead maximally while applying overpressure. A positive test was reproduction of pain of the superior shoulder.

Hawkins-Kennedy test: performed by the examiner

flexing the humerus and elbow to 90° and then maximally

internally rotating the shoulder and applying overpressure. A positive test was reproduction of pain of the superior shoulder.

Painful arc: performed by asking the patient to actively abduct his/her shoulder and report any pain during abduction. If pain of the superior shoulder was noted between 60° and 120° of abduction, the test was considered positive.

Empty can test (Jobe test): performed by the examiner elevating the shoulder to 90° in the scapular plane (30°– 40° anterior to the coronal plane) and then placing the shoulder in internal rotation by asking the patient to rotate the shoulder so that his/her thumb was pointing toward the floor. The examiner then applied a downward directed forced at the wrist while the patient attempted to resist. A positive test was considered if weakness was detected of the

involved shoulder as compared bilaterally.

External rotation resistance test: performed by placing the arm at the patient’s side and flexing their elbow to 90°. A medially directed force was exerted on the distal forearm

to resist shoulder external rotation. A positive test was

considered if weakness was detected of the involved shoulder as compared bilaterally.

Cut-off point(s):

An ROC curve analysis for each physical examination test was

used to calculate the AUC, which represents the probability that the test can discriminate between healthy and disease states. The AUC values range from 0 to 1, with an AUC of 1 indicating 100% probability that a given test can discriminate between healthy and SAIS.

The cut point for discrimination was 3

positive tests out of 5.

The operative findings were

used as the reference standard, and the patients were classified as positive or negative for SAIS based on the surgical findings.

Description:

The reference standard was determined via operative findings reported by an operative surgeon blinded to the clinical examination

findings.

The intraoperative reference standard criteria for SAIS were the presence of any of the following: visually enlarged bursa, fibrotic appearing bursa, or degeneration of the supraspinatus tendon at the superficial aspect. Patients

with additional shoulder pathologies such as partial or

full-thickness rotator cuff tears, labral tears, or fraying and instability were not excluded.

After completion

of the history and physical examination, the patients underwent an arthroscopic examination within an average of 2.6 months

(+-2.7mo, range: 1d–8mo) after the clinical examination.

There were no missing values.

Outcome measures and effect size

ROC curve analysis:

The cut point to discriminate between patients with and without SAIS was 3 positive tests out of 5 (AUC=0.79, 95% CI 0.66–0.92; P=0.001).

Diagnostic accuracy for any test combination (≥ 3 out of 5 positive):

Sens: 0.75 (95% CI 0.54-0.96)

Spec: 0.74 (95% CI 0.61-0.88)

LR+: 2.93 (95% CI 1.60-5.36)

LR-: 0.34 (95% CI 0.14-0.80)

Posttest probabilities:

≥ 3 out of 5 positive: LR+= 54.4%

< 3 out of 5 positive: LR- = 12.1%

Author’s conclusion:

The single tests of painful arc, external rotation resistance test, and empty can provide the best diagnostic utility and reliability. The Neer test has clinical utility to screen for SAIS but has only fair reliability. Also of diagnostic utility is the use of the cut point of 3+/5 tests, with 3 or more tests positive of 5 useful in confirming SAIS, whereas less than 3 positive of the 5 tests is helpful in decreasing the  likelihood of SAIS.

Somerville, 2014

Type of study:

Diagnostic test accuracy study

Setting and country:

Two tertiary orthopaedic clinics

Funding and conflicts of interest:

One or more of the authors has declared the following potential conflict

of interest or source of funding: This study received funding through

an internal source that paid for research assistant time to collect data.

Inclusion criteria:

Participants who came to the clinic for their first consultation

for complaints about their shoulder

Exclusion criteria:

Patients

who were referred for shoulder replacement surgery.

Characteristics

N= 139

Mean age ± SD: 46.0 ± 16.0 years

Sex: 101 M / 38 F

The average supraspinatus tendon tear size was 2.4 ±

1.4 cm from anterior to posterior (range, 0.5-6 cm).

We included the following physical examination

tests: (1) supraspinatus test (Jobe test) and full can

test (supraspinatus tears); (2) lift-off test, belly press test,

and internal rotation lag sign (subscapularis tears); (3) lateral rotation lag sign (infraspinatus tears); and (4) painful arc, Hawkins-Kennedy sign, and Neer impingement

sign (tendinosis).

Patients for whom the

physician faced uncertainty in the diagnosis (ie, clinician

rated as above the testing but below the treatment threshold) remained as part of the study group for that diagnosis, and the physical examination maneuvers specific to that diagnosis were then performed.

Cut-off point(s):

Although most patients went on to have surgery, some

were not referred for surgery or opted out. These patients

underwent a standardized MRIa as the reference standard.

All MRIs had an intra-articular injection of gadolinium

done under fluoroscopy. The strength of the MRI

magnet was 1.5 tesla, and the MRI sequences were all protocoled to provide optimal imaging of the lesions being

investigated (axial T1-weighted and T1-weighted fat saturated [fat sat], coronal T1-weighted and T1-weighted fat sat, proton density fat sat, T2-weighted fat sat, and sagittal proton density fat sat sequences). All MRIs were done at a university center by radiologists with substantial expertise in musculoskeletal imaging. Images were interpreted by a fellowship-trained radiologist who was blinded to the physical examination results.

Time between the index test en reference test:

Not specified.

Incomplete outcome data
Not reported.

Outcome measures and effect size

Diagnostic validity of the combination of physical examination manaeuvers:

Supraspinatus tears (includes supraspinatus test, full can test, and lateral rotation lag sign)

Full thickness tears

At least one positive

Sens: 73.6 (95% CI 60.4-83.6)

Spec: 57.5 (95% CI 46.6-67.7)

+LR: 1.73

-LR: 0.46

At least two positive

Sens: 62.3 (95% CI 48.8-74.1)

Spec: 73.8 (95% CI 63.2-82.1)

+LR: 2.37

-LR: 0.51

All three positive

Sens: 18.9 (95% CI 10.6-31.4)

Spec: 98.8 (95% CI 93.3-99.8)

+LR: 15.09

-LR: 0.82

All tears

At least one positive

Sens: 67.2 (95% CI 55.3-77.2)

Spec: 57.6 (95% CI 45.6-68.8)

+LR: 1.58

-LR: 0.57

At least two positive

Sens: 55.2 (95% CI 43.4-66.5)

Spec: 74.2 (95% CI 62.6-83.3)

+LR: 2.14

-LR: 0.60

All three positive

Sens: 14.9 - 8.3-25.3)

Spec: 98.5 (95% CI 91.9-99.7)

+LR: 9.85

-LR: 0.86

Supraspinatus tears with the lateral rotation lag sign removed

Full thickness tears

At least one positive

Sens: 73.6 (95% CI 60.4-83.6)

Spec: 57.5 (95% CI 46.6-67.7)

+LR: 1.73

-LR: 0.46

Two positive

Sens: 62.3 (95% CI 48.8-74.1)

Spec: 75.8 (95% CI 64.1-83.0)

+LR: 2.46

-LR: 0.51

All tears

At least one positive

Sens: 67.2 (95% CI 55.3-77.2)

Spec: 57.6 (95% CI 45.6-68.8)

+LR: 1.58

-LR: 0.57

Two positive

Sens: 55.2 (95% CI 43.4-66.5)

Spec: 75.8 (95% CI 64.2-84.5)

+LR: 2.28

-LR: 0.59

Tendinosis (includes painful arc, Neer test, and Hawkins-Kennedy test)

Tendinosis

At least one positive

Sens: 75.0 (95% CI 50.5-89.8)

Spec: 21.7 (95% CI 15.2-29.9)

+LR: 0.96

-LR: 1.15

At least two positive

Sens: 62.5 (95% CI38.6-81.5)

Spec: 38.3 (95% CI 30.1-47.3)

+LR: 1.01

-LR: 0.98

All three positive

Sens: 31.3 (95% CI 14.2-55.6)

Spec: 62.5 (95% CI 53.6-70.7)

+LR: 0.83

-LR: 1.10

All disease

At least one positive

Sens: 80.5 (95% CI 70.6-87.6)

Spec: 25.9 (95% CI 16.1-38.9)

+LR: 1.09

-LR: 0.75

At least two positive

Sens: 68.3 (95% CI 57.6-77.4)

Spec: 48.2 (95% CI 35.4-61.2)

+LR: 1.32

-LR: 0.66

All three positive

Sens: 45.1 (95% CI 34.8-55.9)

Spec: 75.9 (95% CI 63.1-85.4)

+LR: 1.87

-LR: 0.72

Full thickness tears

At least one positive

Sens: 88.5 (95% CI 77.0-94.6)

Spec: 28.6 (95% CI 20.0-39.0)

+LR: 1.24

-LR: 0.40

At least two positive

Sens: 73.1 (95% CI 59.8-83.2)

Spec: 45.2 (95% CI 35.0-55.9)

+LR: 1.33

-LR: 0.60

All three positive

Sens: 51.9 (95% CI 38.7-64.9)

Spec: 72.6 (95% CI 62.3-81.0)

+LR: 1.90

-LR: 0.66

Authors’ conclusion:

No test in isolation is sufficient to diagnose a patient with rotator cuff damage. A combination of tests improves the

ability to diagnose damage to the rotator cuff. It is recommended that the internal rotation and lateral rotation lag signs be

removed from the gamut of physical examination tests for supraspinatus and subscapularis tears.

Michener, 2009

Was a consecutive or random sample of patients enrolled?

Yes, but 3 patients refused to participate, and 7 did not undergo the reference standard.

Was a case-control design avoided?

Yes

Did the study avoid inappropriate exclusions?

7 patients refused to undergo the reference standard, these were excluded.

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes (Each clinician independently

performed a standardized history and physical examination and was blinded to each other’s findings and without knowledge of any imaging studies.)

If a threshold was used, was it pre-specified?

Yes

Is the reference standard likely to correctly classify the target condition?

Yes

Were the reference standard results interpreted without knowledge of the results of the index test?

Yes (The reference standard was determined via operative findings reported by an operative surgeon blinded to the clinical examination

findings.)

Was there an appropriate interval between index test(s) and reference standard?

Yes

Did all patients receive a reference standard?

All patients who were included received the refence standard

Did patients receive the same reference standard?

Yes

Were all patients included in the analysis?

Yes

Are there concerns that the included patients do not match the review question?

No

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

No

Are there concerns that the target condition as defined by the reference standard does not match the review question?

No

CONCLUSION:

Could the selection of patients have introduced bias?

RISK: LOW

CONCLUSION:

Could the conduct or interpretation of the index test have introduced bias?

RISK: LOW

CONCLUSION:

Could the reference standard, its conduct, or its interpretation have introduced bias?

RISK: LOW

CONCLUSION

Could the patient flow have introduced bias?

RISK: LOW

Somerville, 2014

Was a consecutive or random sample of patients enrolled?

Yes, but 15 patients refused

to undergo one of the reference standard tests or canceled

their test.

Was a case-control design avoided?

Yes

Did the study avoid inappropriate exclusions?

15 patients refused to undergo the reference standard, these were excluded.

Were the index test results interpreted without knowledge of the results of the reference standard?

Yes (We ensured that the physician performing the physical examination tests did not review any available imaging studies or reports before evaluating the patient.)

If a threshold was used, was it pre-specified?

Yes

Is the reference standard likely to correctly classify the target condition?

Yes (There is good evidence

to suggest that MRIa is a comparable reference standard to arthroscopy, and MRIa has been shown to be highly sensitive

and specific for detecting both rotator cuff and labral injuries)

Were the reference standard results interpreted without knowledge of the results of the index test?

Yes (The surgeon

performed a systematic diagnostic arthroscopy, taking care to visualize and evaluate the integrity of all

pertinent anatomy, and was required to complete a standardized

checklist documenting any findings for each structure (Appendix 2, available online). We developed

this to minimize differences between surgeons due to variations

in methods of examination and to minimize any detection bias should the clinician recall the physical

examination or imaging at the time of interpreting the surgical

examination.

Images were interpreted

by a fellowship-trained radiologist who was blinded tow the physical examination results.)

Was there an appropriate interval between index test(s) and reference standard?

Unclear

Did all patients receive a reference standard?

All patients who were included received the refence standard

Did patients receive the same reference standard?

No, but:

“There is good evidence

to suggest that MRIa is a comparable reference standard

to arthroscopy, and MRIa has been shown to be highly sensitive

and specific for detecting both rotator cuff and labral

injuries.”

Were all patients included in the analysis?

Unclear

Are there concerns that the included patients do not match the review question?

No

Are there concerns that the index test, its conduct, or interpretation differ from the review question?

No

Are there concerns that the target condition as defined by the reference standard does not match the review question?

No

CONCLUSION:

Could the selection of patients have introduced bias?

RISK: LOW

CONCLUSION:

Could the conduct or interpretation of the index test have introduced bias?

RISK: LOW

CONCLUSION:

Could the reference standard, its conduct, or its interpretation have introduced bias?

RISK: LOW

CONCLUSION

Could the patient flow have introduced bias?

RISK: LOW