Paste your Diagnostic Studies Appraisal Worksheet
Citation:
Jarbo KA, Hartigan DE, Scott KL, Patel KA, Chhabra A. Accuracy of the Lever Sign Test in the Diagnosis of Anterior Cruciate Ligament Injuries. Orthop J Sports Med. 2017;5(10):2325967117729809. Published 2017 Oct 11. doi:10.1177/2325967117729809
A. ARE THE STUDY RESULTS VALID?
1. Did the investigators include subjects with all levels or stages or the condition being evaluated by the index test?
This study focused on the accuracy of the use of the lever sign test in the diagnosis of patients with anterior cruciate ligament tears. Differential grades of tears were not included in this study. The investigators included individuals with a mean patient age of 23 and a range of 15-66 years-old. 102 individuals were divided in to groups of 54 surgical patients and 48 nonsurgical patients. All patients who had chief complaint of acute knee pain and came in for an evaluation within the last month since their injury or onset of symptoms were included in the study. If the patients’ knees were operated to address any surgical abnormality (meniscal, chondral, and/or ligament) before January 31, 2015, they were placed in the surgical group. This procedure is used to minimize bias. If the patients’ knees were not operated on, even if surgery was necessary, they were placed in nonsurgical group. Magnetic resonance imaging (MRI) was used as the reference standard for ACL injuries. Patients were excluded if they had not undergone an MRI.
2. Did the investigators compare results form the index test to results from a “gold standard” comparison diagnostic test?
Yes, the investigators compared the results of the lever sign test to MRI, anterior drawer test, Lachman’s test, and the pivot-shift test.
3. Were the individuals performing and interpreting each test’s results unaware of the other test’s results (were they masked or blinded)?
The article states that the investigators were blinded to the patient past medical history, examination findings, radiographic and MRI findings, and operative procedure. The patients in the surgical group were checked in to both clinic and operating room under anesthesia as an effort to keep the investigators blinded. The examination conducted in the operating room was recorded and used for the surgical group. The diagnosis for the awake patient was already given to the investigator by the time that the patient had reached the operating room. As a way to minimize bias, the examination in the operating room was conducted by a different provider. ACL status for the surgical group was determined by diagnostic arthroscopic surgery and for the nonsurgical group, it was the use of MRI.
4. Was the time between application to the index test and the “gold standard” comparison diagnostic test short enough to minimize the opportunity for change in the subjects’ condition?
Yes, the index test (lever sign test) and the “gold standard” comparison tests (Anterior Drawer, Lachman’s, pivot-shift) were all completed on the initial visit. For the surgical group, the 4 tests were done with the patients under anesthesia. The tests were all done at the same time at the initial visit so there was virtually no time for the subjects’ condition to change at all.
5. Did the investigators confirm their findings with a new set of subjects?
No, the investigators did not find a new set of subjects to confirm their findings with.
B. WHAT WERE THE RESULTS?
1. Summarize the results of the study. Include the following, if reported: sensitivity, specificity, +ve predictive values, -ve predictive values, +ve likelihood ratios, -ve likelihodd ratios and correlation coefficients.
The results of this study revealed that performance on the lever sign test as a diagnostic assessment showed a 76% accuracy rate on non-surgical patients and a 77% accuracy rate on surgical patients when comparing it to the MRI as a reference standard. Their combined rate was 77% collectively. There were no statistical significant differences when comparing the sensitivity/specificity of the test when performed on both of the patient groups. The sensitivity % in the nonsurgical group were 68 and 86 for the surgical group. The specificity % in the nonsurgical group were 96 and 85 for the surgical group. The positive predictive value of the lever sign test was 92% in the nonsurgical group and 83% in the surgical group. In total, the % was 87. The negative predictive value however, was much lower at 70% for the nonsurgical group and 71% for the surgical group. In total, their combined % was 71. In the study, the sensitivity was highest for the Lachman (90%), next by the anterior drawer (88%), lever sign (63%), and then the pivot shift (59%) tests. Ranking specificity by tests, the pivot shift was highest (98%), followed by the Lachman (96%), anterior drawer (94%), and finally the lever sign (90%). Accuracy was highest in the Lachman test at 93% and lowest at 77% for the lever sign test. Likelihood ratios and correlation coefficients values were not recorded in this study.
2. Is the index diagnostic test reliable?
Yes, the lever sign test is a fairly reliable diagnostic test for ACL tears ranking just below the Lachman test. Historically, the Lachman test is deemed as the most accurate and reliable for diagnosing ACL tears at 93% accuracy and the lever sign test is below it as 77%. This test can be useful and effective in the diagnostic of an ACL tear in clinical examination settings for all sorts of specialty physicians and providers across all sorts of fields and training backgrounds
3. Is the index diagnostic test valid?
Yes, the 77% accuracy percentage of the lever sign test when compared to the reference standard of an MRI shows that the test is valid for the most part,
4. What is the meaning (application) of these statistical findings for your patient/client case?
The meaning of these statistical findings of the lever sign test shows that it can be incorporated in to the clinical setting to help determine the diagnosis of an ACL injuries in patients. Although it does not have the accuracy of the Lachman test (93%) or the anterior drawer test (91%), it can still be a contributor to the diagnostic routine of the physicians or specialists in determining the possibility of an ACL tear. Due to its lack of significant differences between different levels of testers, the lever sign test does not require the strength of the examiner or the size of the patient to do the test and that is an advantage that no other tests can offer.
C. Applicability of evidence to your Patient/Client
1. Are there clinically meaningful differences between the subjects in the study and your patient?
No, my patient falls within the realm of the study population. My patient is a 25 year-old male with an ACL tear in his left knee. His grade 3 tear diagnosis has been confirmed by the physician through the use of an MRI.
2. Will the reproducibility of the test result and its interpretation be satisfactory in my setting?
Yes, as stated in the previous questions, it can be done in a variety of clinical settings and does not require much space or time to administer the test. The administration of the test is highlighted in the study and its flexibility with a wide spectrum of testers offers it more advantage over the other tests. The lever sign test is a diagnostic test used in the assessment of knee injuries concerning the ACL. Its interpretation can be satisfactory quite frankly due to its versatility and it can certainly contribute to the welfare of the physician’s plan of care for the ACL patients.
3. Are the results applicable to my patient?
Yes, the results are fairly applicable to my patient. His diagnosis qualifies him for the studies because it is used to assess ACL injuries.
4. Will the results change my management?
Yes, this would be a test that I would incorporate as a part of my diagnostic routine when assessing patients with suspected ACL tears. The test offers versatility and efficiency as it can be done in a variety of clinical settings. Since the test does not depend on the testers’ strength or the size of the patient, it is considered to be an advantageous quality that the other tests cannot offer. Although this test is proven to be a fairly accurate assessment of an ACL tear, I will also incorporate other tests like the Lachman or anterior drawer in my diagnostic routine in order to further validate my diagnostic of my patients.
5. Will patients be better off as a result of the test?
I think the test can be a helpful contributor to the welfare of my patients. The test can be done efficiently and quick, but I don’t believe the test can be used alone to fully assess the patient’s suspected ACL tears. The test should be incorporated along with other tests and finally with an MRI to make sure that the findings were accurate and it can certainly be beneficial to the patient’s diagnosis if multiple confirmations can be found with multiple tests involved.
D. Conclusion: Answer as: Yes, No, Or Cannot Tell.
1. The results or recommendations are valid (from A). Yes the results are valid. The investigators compared the findings to the gold standards, ensured the tests were completed in an optimal time frame, and the examiners who recorded the scores for the index test were different from those who recorded the gold standard tests. Additional testing with a new group of subjects would increase the validity of the study.
2. The results are clinically important (from B). Yes the results are clinically important. The accuracy of the lever sign test gives therapists another tool to assess the ACL of the injured patients. The structure of the test requires little time, space and is not taxing at all on the patient or the testers which might give it a slight advantage over the other tests.
The results are relevant to my practice (from C). Yes the results of this study are relevant to my practice. The additional tool allows us to be able to incorporate more versatility in my practice will give me additional confessay in here…