Of 1,512 eligible individual EMRs, 725 met inclusion criteria (Figure 1). Reasons for excluding EMRs included: no physician data sharing agreement (n=133); injury occurred prior to January 2014 (n=373); chronic ACL deficiency (n=114); ACL re-tear (n=37); osteoarthritis (n=68); and mis-coding (i.e., a non-knee injury being coded as a knee injury) (n=76). There was no difference in sex (included; 47.7% female, 95%CI 44.1, 51.4: excluded; 42.4% female, 95%CI 39.0, 45.9) or age (included; median age 26 years, range 15-45: excluded; median age 29 years, range 15-45) between the patients whose EMRs were included and those that were excluded.
The demographic characteristics and availability of clinical criterion standard data of all participants’ records that met the inclusion criteria (n=725) are presented in Table 2. The median age of participants was 26 years (range 15-45), 47.7% were female and 86.6% were injured participating in sport. The median time from injury to AKIC assessment was 176 days (range 10-798). The majority of participants had undergone an MRI (89.8%), 68.1% had been assessed by an orthopaedic surgeon, and 39.3% had undergone surgery (i.e., arthroscopy or ACL reconstruction).
Of the 725 EMRs that met the inclusion criteria for the study, 436 (60.1%) represented a patient with a full-thickness ACL tear (ACL+) based upon the reference standard. A summary of demographic characteristics, potential diagnostic variables, and treatment pathway information by ACL status is presented in Table 3. Sex, age and body mass index did not differ between study groups. Although no single diagnostic indicator emerged, on average a greater proportion (p<0.001) of the ACL+ study group reported a non-contact or plant-pivot mechanism of injury; a ‘popping sensation’, pain, immediate swelling, instability or inability to continue their activity at the time of injury; instability and an inability to return to activity at some point since the injury, and a family history of ACL tear compared to the ACL- group. On clinical exam, a greater portion of those in the ACL+ group demonstrated a positive Lachman, positive pivot shift, or positive posterior drawer test compared to the ACL- group.
The healthcare practitioner survey was completed by 17 clinicians (8 physiotherapists, 6 primary care sport and exercise medicine physicians, and 3 orthopaedic surgeons) with a range of 4-43 years of clinical experience. Across respondents, the most commonly selected potential diagnostic criteria for an ACL tear included: 1) positive Lachman test (65% of respondents ranked as the most important clinician-generated diagnostic criteria), 2) hearing or feeling a ‘pop’ at the time of injury (59% of respondents ranked as most important time of injury diagnostic criteria), 3) patient-reported knee instability since the injury (59% ranked as the most important clinical history diagnostic criteria), 4) plant/pivot mechanism of injury (53% ranked as the most important mechanism of injury diagnostic criteria) and, 5) age less than 25 years (47% ranked as the most important participant characteristic diagnostic criteria).
Table 4 summarizes the variables prioritized for univariable logistic regression by descending rank order based the cumulative number of EMRs with available data by study group (ACL+ and ACL-). In keeping with our sample size calculation, univariable logistic regression was performed on 497 (68.6%) EMRs (321 ACL+ and 176 ACL-) containing complete data for both prioritized (age, sex, sport-related injury, Lachman test result, posterior drawer test result, family history of ACL tear and immediate swelling at the time of injury) and incidental (i.e., variables available in the data that did not meet selection criteria) variables (time between injury and assessment, valgus stress test result, varus test result). Despite being significant on univariable analyses, or ranking high on healthcare practitioner survey, feeling or hearing a ‘pop’ at the time of injury, mechanism of injury, patient-reported knee instability since the injury, or anterior drawer and pivot shift test result were inconsistently reported across EMRs and were not included due to a lack of data.
The results of univariable logistic regression models assessing the relationship between potential individual predictors and ACL status are presented in Table 5. Variables that were significantly associated with ACL tear at p<0.1 included age (p = 0.001), sport-related injury or trauma (p = 0.094), family history of ACL tear (p = 0.032), immediate swelling at time of injury (p = 0.001) and Lachman test result (p <0.001).
The results of the multivariable logistic regression models are summarized in Table 6. The first model included patient-reported variables (age, sport-related injury, immediate swelling, and family history ACL tear) only, while the second model included a combination of patient-reported (age, sport-related injury, immediate swelling, and family history ACL tear) and clinician-generated variables (Lachman test result). In the patient-reported model older age, sport-related injury, immediate swelling, and family history of ACL tear was found to be significantly associated with a full-thickness ACL tear diagnosis. When the Lachman test result was considered alongside the patient-reported variables in the combined model, only older age, immediate swelling, and a positive Lachman test result were significantly associated with the diagnosis of a full-thickness ACL tear.
Model performance is summarized in Table 7. The patient-reported variable only model had an accuracy of 84.0% (95%CI 77.1,89.5), sensitivity of 0.60 (95%CI 0.44,0.74), specificity of 0.95 (95%CI 0.89,0.98) and yielded a maximal AUC of 0.86. Alternatively, the combined patient-reported and clinician-generated variable model had an accuracy of 94.7% (95%CI 89.8,97.7), sensitivity of 0.94 (95%CI 0.88,0.98), specificity of 0.95 (95%CI 0.82,0.99) and AUC of 0.97. It is interesting to note that the performance of the Lachman test alone was comparable to the combined patient-reported and clinician-generated variable model [accuracy rate 94.0% (95%CI 88.9,97.2), AUC (0.94), sensitivity 0.94 (95%CI 0.91,0.99), specificity (0.94 (95%CI 0.76,0.96), positive predictive value (0.94 (95%CI 0.88,0.98), negative predictive value (0.94 (95%CI 0.82,0.99), LR+ of 8.1 (95% CI 3.8,17.1), LR- of 0.03 (95%CI 0.01,0.10)].