Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury:a systematic review
Michael S Swain 1,2*,Nicholas Henschke 1,3,Steven J Kamper 1,4,Aron S Downie 1,2,Bart W Koes 5and Chris G Maher 1
*Correspondence:[email protected] 1
The George Institute for Global Health,Sydney Medical School,University of Sydney,Missenden Rd,PO Box M201,2050Sydney,Australia 2
Department of Chiropractic,Faculty of Science,Macquarie University,2109Sydney,Australia
Full list of author information is available at the end of the article
CHIROPRACTIC & MANUAL THERAPIES
©2014Swain et al.;licensee BioMed Central Ltd.This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0),which permits unrestricted use,distribution,and reproduction in any medium,provided the original work is properly credited.The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/)applies to the data made available in this article,unless otherwise stated.
Swain et al.Chiropractic &Manual Therapies 2014,22:25http://www.chiromt.com/content/22/1/25
The anterior cruciate ligament(ACL)is an important stabilising structure of the knee and its disruption is as-sociated with pain and activity limitation.The annual incidence of ACL injury ranges from0.01%to0.05%, however it is higher in sporting groups and most fre-quently affects individuals during late adolescence and early adulthood[3–5].The prevalence of ACL injury in adults presenting to primary care with acute knee pain is estimated to be4%.Many cases are initially missed in primary care and these undiagnosed ACL injuries are of concern because of the risk of cartilage tear and premature knee osteoarthritis.
Clinical diagnosis of ACL injury is based upon history and physical examination findings with suspected cases confirmed by MRI or arthroscopy.Numerous clinical tests and findings have been proposed to aid the diagno-sis of ACL injury.A popping sound,swelling and in-stability following high impact sport trauma along with a positive Lachman’s,anterior draw or pivot shift test is the most common method of clinical diagnosis.How-ever,there are over25specific physical tests and numerous features from the clinical history that have been proposed for detection of ACL injury.At present the diagnostic accuracy of these tests is unclear.
Most existing reviews evaluating the accuracy of tests to diagnose ACL injury[6,11–14]are now over a decade old and contain methodological limitations such as in-clusion of inappropriate studies and pooling of estimates from heterogeneous studies.Since these reviews were published there has been much progress in the diagnos-tic field with regard to study appraisal and synthesis .There is now a greater appreciation of how design features may lead to biased estimates of diagnostic test accuracy and when meta-analysis is justified.In addition it is likely that more recent primary research studies have been conducted in the area of ACL diagnosis.
The objective of this systematic review was to report the diagnostic accuracy of clinical tests for the diagnosis of ACL injury and describe the quality of research evalu-ating these tests.
A systematic review protocolwas registered at the International Prospective Register of Systematic Reviews-PROSPERO2012:CRD42012002069.
Identification of selected studies
Electronic databases(PubMed,MEDLINE,EMBASE,and CINAHL)were searched for eligible diagnostic studies from the earliest year possible up to19th of June2013.The search strategy was developed for PubMed and modified for use in other databases(Additional file1:Table S1).The reference lists of all included publications and relevant systematic reviews were checked and forward citation searches performed.
Diagnostic studies were eligible if they compared the ac-curacy of history taking or physical examination to an acceptable reference standard(arthroscopy,arthrotomy, or MRI)in the identification of ACL injury.Both pro-spective and retrospective studies were eligible for inclu-sion.We did not include case control studies as they substantially overestimate diagnostic accuracy compared with studies that use a clinical population.
The focus of this review was on studies that evaluated patients presenting to a care provider for diagnosis of knee pain or dysfunction,where the diagnostic accuracy of individual,or combinations of,history features or physical assessment procedures was evaluated.Studies in which a substantial proportion of recruited patients had already been diagnosed with ACL injury were excluded to minimise verification bias.
Included studies had to report sufficient data on diagnos-tic tests to enable construction of a2×2table so estimates of diagnostic accuracy(such as sensitivity and specificity) could be calculated.Studies that evaluated the accuracy of an unspecified combination of history and physical examin-ation,such as clinical diagnosis or global clinician judgment were excluded as they do not allow for replication,valid-ation and generalization of the study results.
If studies had been reported in abstracts or conference proceedings,the related full publications were retrieved if available,but only full articles published in peer-reviewed journals were included.Studies published in all languages were considered eligible and translations were sought where necessary.
Two authors(MS and NH)independently screened all titles and abstracts identified in the searches with respect to the inclusion and exclusion criteria.Full text copies of potentially relevant articles were retrieved and final in-clusion or exclusion was determined.Disagreements re-garding inclusion were resolved by consensus,including a third review author(SK)where necessary.
Three review authors(MS,NH,SK)independently ex-tracted information from the included studies.Data were extracted into a specifically designed spreadsheet and in-cluded details on the study design,setting,enrolment procedures,number of participants,patient demograph-ics,and time since initial ACL injury.Details of the type of index test and the type of reference standard were also extracted and the proportion of participants with ACL injuries was calculated for each included study.
Diagnostic two-by-two tables(true positive,false positive, true negative and false negative)were either extracted from the publications or reconstructed using information from other reported parameters(sensitivity,specificity,or pre-dictive values).Uninterpretable index test outcomes,such as an equivocal finding were dealt with as a negative index test finding.The authors of one studywere contacted and provided additional information.
The quality of each included study was assessed by two review authors(MS,NH)using the QUality Assessment of Diagnostic Accuracy Studies(QUADAS-2)checklist .The QUADAS-2checklist consists of four domains relating to patient selection,index test,reference stand-ard,and flow and timing.Each domain is assessed in terms of risk of bias,and the first3domains are also assessed in terms of applicability.The review authors classified each item as“yes”(adequately addressed),“no”(inadequately addressed),or“unclear”(inadequate detail presented to allow a judgment to be made).Disagree-ments were resolved by consensus and consulting with a third(SK)review author where necessary.
Synthesis of results
The two-by-two tables were used to calculate index test summary statistics:sensitivity,specificity,likelihood ra-tios along with their95%confidence intervals using MetaDiSc1.4.Index test accuracy was presented as for-est plots of likelihood ratios,as likelihood ratios provide the best way for clinicians to use diagnostic data to es-tablish clinical diagnoses in patient care.Categorisa-tion of likelihood ratios was adopted from Jaeschke et al.
where positive likelihood ratios(+LR)＜5and a negative likelihood ratios(−LR)>0.2were considered small, +LR5–10and–LR0.1-0.2were moderate,and+LR>10 and–LR＜0.1were considered large,with respect to chan-ging the pre to post-test probability.
Both clinical and statistical heterogeneity as well as methodological quality were evaluated to determine the appropriateness of meta-analysis.Assessment of clinical heterogeneity involved comparison of the study popula-tions,settings,performance of index tests and reference standards among included studies.Assessment of statis-tical heterogeneity involved visual inspection of forest plots and performance of the chi-square(χ2)test and calculation of the inconsistency index(I2)which quantifies the proportion of variation across the included studies that is due to heterogeneity rather than chance.
The initial database searches retrieved21,691citations of which10,796citations remained after duplicates were removed(Figure1).Screening of the titles and abstracts identified285potentially relevant articles that were re-trieved in full text format.Forwards and backwards cit-ation tracking identified12potentially relevant articles which were also retrieved.Fourteen articles were finally included,of which11were published in English[19,23–32] and three in German[33–35].Additional file2:Table S2 lists the reasons for excluding28articles that were included in one or more of the previous five systematic reviews. Description of included studies
Of the14included articles,10had a prospective study design[19,23,24,28–30,32–35],two used a retrospective design[26,27]and for two studies[25,31]the design was unclear(Table1).
Only one studyevaluated the diagnostic accuracy of clinical tests in primary care.The other13studies evaluated the accuracy of clinical tests in secondary con-tact settings,defined here as either a referral to an orthopaedic department or presentation to an accident and emergency department.In three studies the refer-ence standard was MRI[19,24,27],eight studies applied arthroscopy[23,26,29–32,34,35]and three studies ap-plied either arthroscopy or arthrotomy[25,28,33].Only five studies[25–27,29,30]reported in detail the method of index test application with slight variations between them in the way the index tests was performed.
Nine studies[19,23,26,28,30–32,34,35]assessed diag-nostic accuracy for partial or complete ACL injuries, however only four of these[19,23,30,32]provided suffi-cient information to determine if the index test result pertained to a partial or complete disruption of the ACL. Injury severity(partial or complete ACL disruption)was unclear and treated as partial and complete injuries in the remaining studies.Nine studies[19,24–26,28,30,31,33,35] described ACL injuries with concomitant injury to other knee structures,while comorbid knee injuries were unclear or not reported in the remaining five studies[23,27,29,32,34].
There was variability between participants in the in-cluded studies with respect to sample size(50–350), average age(25–40years),proportion of males(52%-100%)and time since ACL injury(one day to longer than one year).The prevalence of verified partial and complete ACL injury ranged from21%-81%.
The QUADAS-2ratings of risk of bias and study applic-ability are shown in Table2.Only one studyad-equately addressed all risk of bias domains.For the14 studies,risk of bias was high or unclear with regard to patient selection for10studies,for the index text four studies,for the reference standard nine studies and for flow and timing eight studies.
Only one studyclearly stated that the reference standard was assessed without knowledge of the results of the index test,while in12studies this was unclear [23–26,28–35].In one study the reference standard was not applied independently of clinical tests.Six stud-ies[24,27,28,32,34,35]included all enrolled participants in the analysis.Across the remaining eight studies [19,23,25,26,29–31,33]the number of participants left out of the analyses ranged from1%-71%of those origin-ally included.
Diagnostic accuracy of clinical tests
A total of nine clinical index tests were identified by this review.Five tests were items from the clinical history (popping sound at time of injury,giving way,effusion, pain,ability to continue activity)and four index tests were applied as part of physical assessment(the anterior draw test,Lachman’s test,prone Lachman’s test,the pivot shift).Three of the tests were also performed under anaesthesia(anterior draw test,Lachman’s test, pivot shift test).Diagnostic accuracy statistics for all index tests are presented as supplemental material (Additional file3:Table S3).The anterior draw, Lachman and pivot shift tests were each evaluated in subgroups where the tests were applied in secondary contact settings to identified partial and complete ACL injury.The chi-square test ranged fromχ2=50.66,6df,P＜0.001toχ2=6.55,4df,P=0.16and the inconsist-ency indexes were typically high(>75%)ranging from 99.2%to38.9%.The three physical tests plotted on the ROC plane as well the subgroups sensitivity and specificity forest plots are presented as supplementary information (Additional file4:Figure S1,Additional file5:Figure S2). The variability in patient spectrum and performance of index tests among the included studies resulted in import-ant clinical and statistical heterogeneity.In addition,only a small number of studies evaluate specific clinical tests,with all but one study at high risk of bias,so a decision was made not to perform a meta-analysis.The diagnostic accur-acy of individual clinical tests for ACL injury along with thresholds for defining clinical usefulness(i.e.small,moder-ate and large change in post-test probability)are illustrated in Figure2.The number of studies that evaluated each indi-vidual test ranged from two studies for clinical history items to nine studies for Lachman’s test.
Only two studies[19,30],from different settings(pri-mary and secondary care),investigated test accuracy for clinical history items.Clinical history items had low value in correctly diagnosing ACL injury(+LR range 0.93-2.54,−LR range0.15-1.18)(Figure2).
Six studies[19,23,24,27,31,34]reported the accuracy of the anterior draw test in diagnosing ACL injury.Small, moderate and large+LR(range 1.94-87.88)were ob-served for the anterior draw test across studies.The
large+LR estimates all had wide confidence intervals and were reported in studies with high risk of bias.All–LRs (range0.23-0.74)for the anterior draw test were within the small threshold.
Nine studies[19,23–25,27,31,32,34,35]investigated the accuracy of Lachman’s test in diagnosing ACL injury.Small, moderate and large LRs(+LR range1.39-40.81,−LR range 0.02-0.52)were reported for Lachman’s test across the stud-ies.Studies that report moderate or large LRs tended to be at risk of bias and had wide confidence intervals.One study investigated the prone Lachman’s test and reported small and imprecise LRs(+LR3.50,−LR0.38).
Five studies[23,24,30,31,34],all at risk of bias,evalu-ated the accuracy of the pivot shift test.Small,moderate and large+LRs(range4.37-16.42)and small–LRs(range 0.38-0.84)were reported for the pivot shift test in all studies.Accuracy estimates with moderate and large +LRs tended to lack precision.
Five studies at high risk of bias[26,28,30,31,33]inves-tigated physical tests when examination was performed under anaesthesia(EUA)(Additional file6:Figure S3). The anterior draw test,Lachman’s test and pivot shift test appear to provide improved diagnostic accuracy when examination is performed under anaesthesia.While LRs are moderate-large the confidence intervals around the+LR estimates are wide.
Only one study,from the primary care setting with low risk of bias,provided data on the effect of combin-ing clinical tests.Specifically,this included two or three positive history tests(from a list of popping sensa-tion,giving way,effusion,immediate pain at trauma and continuation of activity impossible)as well as a positive anterior draw or Lachman’s test(Figure3).The addition of a positive anterior draw test to the combinations of two positive history tests increase the+LR(4.81)close to moderate diagnostic threshold.The addition of a third
Table1Characteristics of included studies
First author, year Design Setting Participants Partial and
Beldame, 2011Prospective University hospital,France.*112patient/knees with an
indication for knee arthroscopy.
Boeree,1991 Prospective Orthopaedic clinic,UK.203patient/knees referred from
GPs or the A&E.
Decker,1988 Prospective Hospital,Germany.†108patient/knees suspected
to have knee ligament injury.
Harilainen, 1987Unclear Emergency department,
†350patient/knees with acute
Katz,1986Retrospective Community hospital,USA.85participant/knees with knee
injuries presenting for arthroscopy.
Lee,1988Retrospective Orthopaedic department
of a hospital,USA.79magnetic resonance studies
of the knee were reviewed.
Lucie,1984 Prospective Orthopaedic clinic,USA.50patient/knees with acute
traumatic knee haemarthrosis.
Mulligan,2011 Prospective Orthopaedic surgery and
sports medicine service,
*†52patient/knees with a
complaint of knee pain referred
from emergency department.
Noyes,1980 Prospective Orthopaedic/Sports
medicine knee clinic,USA.
that had traumatic haemarthrosis.
Richter,1996 Prospective Hospital,Germany.74patient/knees with effusion
of the knee following trauma.
Schwartz, 1997Prospective Hospital,Germany.58patient/knees with acute
Tonino,1986 Unclear Hospital,Netherlands.*66patient/knees with acute
symptoms of a ligamentous
lesion of the knee after trauma.
Wagemakers, 2010Prospective GP clinics,Netherlands.*134patient/knees with
new knee symptoms.
Wong,1999 Prospective Orthopaedic department of
a hospital,Hong Kong.
91patient/knees with an acute
*Not all participants evaluated by index test(s).
†Not all participants evaluated by reference standard.
history test produced a large but imprecise+LR(35.64) but reduced the–LR(0.82).
This systematic review included14studies that evalu-ated the diagnostic accuracy of clinical tests for ACL in-jury.Just one study,which was the only study performed in primary care,had a low risk of bias and showed that re-sults of individual tests produce only small changes in the probability of ACL injury.The same study investigated the diagnostic accuracy of combining history items with phys-ical tests and reported improved accuracy when doing so. The other studies,performed in secondary contact settings, had moderate to high risk of bias and reported quite di-verse and imprecise estimates of diagnostic accuracy.Based upon these findings,clinical tests in combination,but not individually,may assist the diagnosis of ACL injury.
The key strengths of the review include a pre-specified and registered review protocol,the use of inclusion criteria to ensure that the study settings reflected clinical practice and the evaluation of study quality using the QUADAS-2 checklist.This review also reported likelihood ratios as they are the preferred approach to report estimates of diagnostic accuracy.The limitations of the study were that sparse data were available on most clinical tests and that we were unable to perform a meta-analysis due to heterogeneity in the estimates of diagnostic accuracy,risk of bias and clinical characteristics.The heterogeneity among studies is well il-lustrated by the results for Lachman’s test,where reported +LRs ranged from1.5to102,risk of bias varied and ACL injury prevalence in the included studies ranged from21% to81%.
The clinical tests reviewed are those most commonly used for the diagnosis of ACL injury in clinical practice. Our findings suggest that a clinician cannot rely on a single clinical test in isolation,particularly one from the clinical history,to identify patients with ACL injury.Due to the fact that diagnostic decisions regarding ACL in-jury are not made on the basis of a single test,studies should ideally focus on test performance in combination. The best estimates of diagnostic accuracy come from Wagemakers et al.whose data suggest that there may be some potential in combining clinical tests,spe-cifically the anterior draw test with two or three of the following five history findings:popping sensation,giving way,effusion,immediate pain at trauma and inability to continue activity.Notwithstanding,these findings must be interpreted with caution as a major drawback of Wagemakers et al’s study was its low power to suffi-ciently analyse multiple combined tests.An important direction for future research is identification of the opti-mal combination of currently available clinical tests to accurately diagnose ACL injury.While the literature re-garding the accuracy of currently used tests is of variable quality,those identified in this body of literature(and in-cluded in this review)are the logical candidates to inves-tigate using more robust methods.Such studies are well suited to primary care settings(limiting referral bias), but sample sizes will need to be substantially larger than studies to date in order to investigate multiple sequen-cing of index tests.
In contrast to our findings,previous systematic re-views have concluded that individual clinical tests can be used to accurately diagnose ACL injury[11,14].The
Table2Risk of bias and applicability concerns summary based on the QUADAS-2checklist
Risk of bias Applicability concerns concerns
First author,year Patient selection Index test Reference standard Flow and timing Patient selection Index test Reference
standard Beldame,2011?++-+++ Boeree,1991-?+++++ Decker,1988?+?-+++ Harilainen,1987+??-+++
Lee,1988-+?-+++ Lucie,1984-+?-+++ Mulligan,2011++??+++ Noyes,1980-?+-?++ Richter,1996-+?++++ Schwartz,1997-++++++ Tonino,1986-+??+++ Wagemakers,2010+++++++ Wong,1999+??++++ Judgements on risk of bias and applicability concerns:−=high risk;?=unclear risk;+=low risk.
difference in conclusions is primarily because we only included studies evaluating a clinical sample with diag-nostic uncertainty.Other reviews have included case–control studies,a study design which has been shown to inflate estimates of diagnostic accuracy.Our decision to interpret test accuracy via clinically usefully thresholds of likelihood ratios also distinguishes this from previous reviews.A final point of difference con-cerns our decision not to pool accuracy estimates, which we believe this is the only appropriate course given the risk of bias and heterogeneity evident in the included studies.
Although we applied a critical approach to study selec-tion we still identified several methodological issues that affect internal validity and may result in overestimation of diagnostic test accuracy[17,37].The spectrum of pa-tients in the included studies varied because of different methods in patient sampling.Most obviously,the char-acteristics of the samples varied due to the differences in study inclusion and exclusion criteria.Two recent pro-spective cohort studies illustrate this:Wagemakers et al.
included participants with new knee symptoms and excluded participants who were suspected of knee frac-ture;whereas Beldame et al.included participants with indication for knee arthroscopy,meaning the sam-ple was subject to referral filter bias.The paucity of diagnostic studies for ACL injury conducted in primary care also suggests caution should be taken when general-ising these findings to this setting.
In some instances the index tests were not applied to all participants prior to the application of the reference test,or the reference test was performed without a clin-ical test.There was under reporting of reasons for pa-tient exclusion and withdrawals.Reporting was deficient in most primary studies which limited our appraisal of study quality.This is perhaps most evident with respect to risk of bias domains associated with blinding of the index tests and reference standards.Where multiple index tests were applied concurrently it is unclear the extent to which knowledge of prior testing(test review bias)overestimated the accuracy of index tests.Similarly, there was concern that the invasive nature of knee arth-roscopy or surgery as a reference test may have affected the flow of participants through some studies.In
instances a patient with a negative index test may not have received a reference test creating partial verification bias.
This systematic review of clinical tests for ACL injury in-corporates the most recent knowledge of diagnostic test accuracy methods.The findings highlight the lack of clinical test accuracy data to support the use of history and physical examination to diagnose ACL injury.Most diagnostic studies on this topic contain methodological flaws which can overestimate the diagnostic accuracy of clinical tests.The available high quality evidence sug-gests that tests are not useful on their own but combina-tions may prove to be more useful.
ACL:Anterior cruciate ligament;QUADAS:QUality assessment of diagnostic accuracy studies;+LR:Positive likelihood ratio;-LR:Negative likelihood ratio; EUA:Examination under anaesthesia.
The authors declare that they have no competing interests.
Conception and design:MSS,NH,SJK,BWK,CGM.Analysis and interpretation of the data:MSS,NH,SJK,ASD,BWK,CGM.Drafting of the article:MSS,NH, SJK,ASD,CGM.Critical revision of the article for important intellectual content:MSS,NH,SJK,ASD,BWK,CGM.Final approval of the article:MSS,NH, SJK,ASD,BWK,CGM.Statistical expertise:NH,SJK,CGM.Administrative, technical,or logistic support:MSS,NH,SJK,CGM.Collection and assembly of data:MSS,NH,SJK,ASD.All authors read and approved the final manuscript. Author details
1The George Institute for Global Health,Sydney Medical School,University of Sydney,Missenden Rd,PO Box M201,2050Sydney,Australia.2Department of Chiropractic,Faculty of Science,Macquarie University,2109Sydney,Australia.3Institute of Public Health,University of Heidelberg,69120Heidelberg, Germany.4Department of Epidemiology and Biostatistics,EMGO+Institute, VU University Medical Center,1081BT Amsterdam,Netherlands.5Department of General Practice,Erasmus MC,University Medical Centre,503015GE Rotterdam,Netherlands.
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