Download Brief Report

Brief Report
Shoulder Imaging – review of existing
guidelines
Reviewer
Natalie Hardaker
Literature search
Amanda Bowens
Date Report Completed
21 February 2011
Important Note:
•
The purpose of this brief report is to review existing international clinical
guidelines for best practise imaging for shoulder conditions, particularly those
arising due to injuries.
•
A reasonable attempt has been made to find and review papers relevant to the focus
of this report; however it does not claim to be exhaustive.
•
The document has been prepared by the staff of Research, ACC. The content does
not necessarily represent the official view of ACC or represent ACC policy.
•
This report is based upon information supplied up to 31 December 2010
Accident Compensation Corporation
Background
This brief report summarises imaging recommendations for the shoulder that are
presented in existing international clinical guidelines. The intention is to identify any gaps
between these recommendations and ACC’s requirements for referral guidelines. The
target audience of the final ACC guideline is both primary and secondary care
practitioners; to deliver a consistent message to all physicians potentially involved in the
referral process.
Investigation
The following databases were searched: Medline, National Guideline Clearinghouse, NHS
Guideline finder and the TRIP database for the period 2005 to 2010. Reference checking
was carried out on identified key publications.
Seven guidelines that include recommendations about diagnostic imaging of shoulders
were identified and are summarised in the table below. Six of these, including ACC’s
shoulder guideline, are good quality and were developed using recognised evidence based
methodologies (i.e. systematic review of literature relating to diagnosis, and consultation
with experts). The remaining guideline; Imaging Guidelines by the Royal Australian and
New Zealand College of Radiologists (RANZCR), was of lower quality, it was developed
through consensus opinion of a panel of diagnostic imaging specialists, stating that “where
possible the recommendations are prepared from evidence based reports published in the
literature”; however there are no references included in the guideline. Three of the seven
guidelines include guidance notes on imaging and the foetus1-3 and one of the guidelines
4
includes information about the risks of ionising radiation . It would be appropriate
include this information in the current ACC guideline to acknowledge the health & safety
associated with diagnostic imaging.
Inclusion/Exclusion: All of the guidelines were included, but in the final analysis more
weight is given to the six good quality evidence based guidelines.1-6
Comparison of messages: The recommendations from the ‘included’ guidelines were
compared for consistency of messages. Four1 3-5 of the seven existing guidelines included a
‘graded’ recommendation based on the quality of the evidence used to inform the
recommendation. The existing grades were aligned and considered in the current ACC
recommendations.
Accident Compensation Corporation
Page 2
Guideline
1. ACC 2004
The diagnosis and management
of soft tissue shoulder injuries
and related disorders: best
practice evidence-based
guideline.
Crude Quality
Assessment
Scope
Good quality, evidence based
systematic review; using robust
methodology & consultation with
expert panel
Rotator cuff disorders
Inlcude/
Exclude
Include
Frozen shoulder
Glenohumeral instabilities
Acromioclavicular joint disorders
Sternoclavicular joint disorders
For a primary care audience.
Imaging risk to the foetus not included
2. Bussieres et al 2008
Diagnostic imaging practice
guidelines for musculoskeletal
complaints in adults: an
evidence-based approach – Part
2: upper extremity disorders.
Good quality, evidence based
systematic review; using robust
methodology & consultation with
expert panel
Non-traumatic shoulder pain
Include
Glenohumeral joint disorders (Rotator cuff;
frozen shoulder; osteoarthritis; inflammatory
instability)
Significant shoulder/Glenohumeral joint
trauma (e.g. dislocation/fracture)
Acromioclavicular joint disorders
Sternoclavicular joint disorders.
For a primary care audience.
General risk of ionising radiation included
3. Department of Health
Western Australia (2007).
Diagnostic imaging pathways
(online decision support tool)
Good quality, evidence based
systematic review & consultation
with expert panel.
Decreased external rotation (frozen shoulder,
osteoarthritis)
Include
Shoulder trauma (Fracture, Rotator cuff,
dislocation)
Impingement syndrome, Rotator cuff tear.
Imaging risk to the foetus included
4. American College of
Radiology (ACR)
Appropriateness Criteria for
Musculoskeletal Imaging (2010).
Good quality, evidence based
systematic review; using robust
methodology & consultation with
expert panel
Acute shoulder pain
Include
Persistent pain
Labral tear
Bursitis or tenosynovitis
Rotator cuff tear & impingement
Septic arthritis
Imaging risk to the foetus not included
5. The Royal College of
Radiologists (RCR), London
(2007)
Based on systematic review of
literature, critical appraisal by
expert panels, and refinement by
Delphi process of consensus.
Painful shoulder; including impingement
syndrome and suspected Rotator cuff tear
Include
Shoulder instability
Imaging risk to the foetus included
6. European commission referral
guidelines for imaging (2000)
th
Based on RCR 4 edition (1998)
guideline, and adapted with
European expert opinion and
evidence
Shoulder Impingement
Include
Shoulder Instability
Rotator Cuff
Imaging risk to the foetus included
7. Royal Australian & NZ
College of Radiologists
(RANZCR) Imaging Guidelines
(2001)
Guideline prepared by panel of
diagnostic imaging specialists. A
consensus approach was adopted
& where possible
recommendations were prepared
from evidence-based reports
published in the current
literature. Literature is of
unknown quality limited
references are listed at the end of
each condition
Accident Compensation Corporation
Algorithmic approach. Provides imaging
guide for suspected: Complex fracture; RC
tear, impingement; Glenohumeral instability;
Tumour.
Include
Imaging risk to the foetus not included
Page 3
Findings
For the purposes of this report the findings will be presented according to the
4
classifications of patient presentations used in Bussieres et al 2008 (number 2 in the
table). It is acknowledged however that these may not be the classifications used in the
final document following consultation with an expert panel.
Accident Compensation Corporation
Page 4
1. Non traumatic shoulder pain, and full or limited movement
X-ray
34
Two of the guidelines state that X-ray is not initially indicated if duration of
pain is less than 4 weeks.
RANZCR7, Australian Online Diagnostic Imaging Pathways2 and ACR6
appropriateness criteria recommend that X-Ray should be the first line
investigation for all presentations of shoulder pain. It is unclear from the
guidelines whether the recommendation is indicating X-Ray upon initial
presentation or; that X-Ray should be the first choice should imaging
investigation be required following a period of conservative care. [See footnote
below] * .
General indications for X-ray are; no response to 4 weeks conservative
treatment3 4, significant activity restriction for more than 4 weeks, non
4
mechanical pain, or the presence of red flags .
Ultrasound (US)
US & MRI are deemed equally useful. US is more cost effective than MRI but
use is largely dependent on local expertise and availability4 6. US is indicated
for soft tissue involvement including suspected Rotator Cuff tear3 4 6, bursitis,
tenosynovitis6, impingement1 3 and preoperatively1 3 to examine integrity of
Rotator Cuff. Although MRI is considered the gold standard4 for shoulder
imaging the guidelines consistently recommend MRI or US equally for nontraumatic shoulder pain. US is considered to be more cost effective4 6; it would
therefore seem pertinent to recommend US in the first instance.
Advanced imaging:
Only one of the guidelines4 outlines in detail when advanced imaging should be
considered.
Advanced imaging and specialist referral are appropriate when4;
•
X-Ray is unremarkable and pain is unresolved
•
Pain & significant disability have lasted more than 6 months
•
Function deteriorates or does not improve
•
There is history of instability
•
Presence of acute, severe post-traumatic acromio-clavicular pain
•
Evidence of other severe pathology
*
RANZCR advise: for general shoulder pain, plain film should always be performed in the initial imaging
assessment of a painful shoulder because pain may be referred from the neck.
Western Australia Online Diagnostic Imaging Pathways advise: X-ray is the initial investigation for all
shoulder problems.
ACR advise: X-Ray is the best initial study, usually appropriate
Accident Compensation Corporation
Page 5
MRI
MRI provides the best image for the shoulder & allows investigation of soft
tissues. MRI indicated where US is unavailable, contraindicated or fails to
establish a diagnosis.
2. Glenohumeral Joint Disorders:
i)Rotator Cuff disorders (tendinopathy)
X-ray
X- Ray does not appear to be indicated where there is clinical suspicion of
rotator cuff disorder. The guidelines either don’t mention X-Ray1 3 5 or agree
that X-Ray is not initially indicated and should only be considered if
47
history/assessment suggests that the patient may have calcific tendonitis ,
4
impingement or to exclude the osteophytes in those patients age >35yrs6.
These recommendations are reasonably consistent across guidelines.
Ultrasound (US)
US is indicated in all guidelines as appropriate for detecting full thickness
rotator cuff tears1-7. It is noteworthy that the accuracy of US is operator
dependent1 6 7. Two of the guidelines2 7, recommend MRI where local expertise
are unavailable and would appear to be a logical alternative. US is indicated to
investigate impingement4 6.
Advanced imaging:
Advanced imaging is indicated particularly when surgery is being considered4.
MRA is suggested to improve diagnostic accuracy4. Though MRA is only
recommended in one of the guidleines4 as it is a high quality guideline, it may
be appropriate to include MRA in the current recommendation as a special
note to be considered on a case by case basis.
It is also noteworthy that 54% of asymptomatic people would show abnormal
appearance of the RC on MRI4, highlighting the need for sound clinical
assessment and reasoning before going to MRI. CT only useful when US &
MRI unavailable or contraindicated6.
MRI
246
MRI is indicated for detecting partial thickness RC tears , suspected labral
6
6
tears and instability . It is also indicated when further investigation of RC
pathology is needed, e.g. when US is equivocal, difficult or negative despite
strong clinical suspicion7. (Both US & MRI will detect impingement4 6, as US is
a more cost effective modality it should be considered prior to MRI.)
4
MRI is indicated for detecting calcifying bursitis within cuff tendons . It is
noteworthy that MRI does not have a significant effect on treatment outcome4.
As MRI is most sensitive to RC and associated soft tissue injury it is
recommended preoperatively to determine the integrity of the RC.
Accident Compensation Corporation
Page 6
ii)Frozen shoulder (Adhesive capsulitis)capsulitis (Frozen shoulder)
X-Ray
Not initially indicated throughout the guidelines
ACC clinical directorate felt that given the usual age group (>50yrs) presenting
with this condition X-Ray should routinely be done to exclude other possible
pathological conditions.
Frozen shoulder/adhesive capsulitis is not included in two of the guidelines1 3.
45
Two of the remaining guidelines recommend that X-Ray is not routinely
indicated unless patient history/assessment suggests the need to exclude other
complicating factors (undefined)4 or arthritis5. One remaining guideline6 does
not specifically define this condition but recommends X-Ray as the best initial
imaging for shoulder pain, it is unclear whether this relates to initial patient
presentation or X-ray as first choice following a period of unsuccessful
conservative treatment.
US indicated when pain is persistent, X-Ray inconclusive or manipulation
being considered. US is recommended when there is clinical suspicion of
arthritis5 X-Ray is also recommended5, however there is no indication of which
is more appropriate.
MRI
MRI indicated when pain is persistent, X-Ray inconclusive or manipulation
being considered.
Three of the guidelines detailed advanced imaging4-6. MRI is indicated when
manipulation is being considered to aid in confirming diagnosis of adhesive
4
capsulitis . MRI indicated where X-Ray is non-contributory and pain is
persistent. Adhesive capsulitis is usually a self limiting condition and pain
ordinarily improves/subsides at 3/125. US or MRI are indicated for cases where
X-ray was non-contributory and/or pain is persistent for longer than 3/122 4-6.
As manipulation is quite an aggressive technique it is also recommended that
MRI be used to confirm diagnosis prior to manipulation.
ACC clinical directorate recommend that further imaging is not routinely
indicated as the diagnosis is unclear. ACC clinical directorate agree MRI
indicated prior to manipulation
iii)Osteoarthritis
X-ray
Include in guideline. No referral recommendation is currently included in
ACC’s shoulder guideline. As OA can be a result of previous injury/conditions
that are covered by ACC, it may be valuable to examine the primary evidence
and investigate the strength of a causal relationship and management of OA.
Only two guidelines detailed this condition2 4. The first guideline4 recommends
that X-Ray not indicated unless pain is unrelieved following 4/52 conservative
treatment. The second guideline2 recommends X-ray is indicated upon clinical
suspicion of OA.
Advanced Imaging Advanced imaging is not detailed in any of the guidelines1-7.
ACC clinical directorate agree this should be included in guideline. X-Ray
should be indicated, as result will direct Rx.
Accident Compensation Corporation
Page 7
iv) Glenohumeral joint inflammatory Arthritis (including; RA, gout, reactive arthritis,
JRA, AS) (Non ACC)
Only one4 of the seven guidelines reviewed specifically includes this condition.
If patient presentation raises clinical suspicion of inflammatory arthritis X-Ray
4
4
is indicated for further investigation . Bussieres identify that septic arthritis is
a critical differential diagnosis and if clinically suspected MRI should be
considered. Septic arthritis is included in the ACR appropriateness criteria6;
and the recommendation is arthrocentesis guided by US or X-Ray, in this case
6
X-Ray and US are recommended equally. The ACR guideline recommends
that MRI and CT may be appropriate.
Based on theses guidelines it is recommended that X-Ray indicated for initial
investigation. US/X-Ray guided arthrocentesis are equally indicated when there
is clinical suspicion of septic arthritis discussion with radiologist may guide
decision.
ACC clinical directorate agree with recommendation – no amendment.
v)Glenohumeral instability (generalised ligamentous laxity, multidirectional,
voluntary/habitual instability, non-traumatic dislocation. Tears of labrum
&/or capsule &/or glenohumeral ligaments can lead to instability.
Dislocation can cause RC tear in middle age or older age)
X-ray
Five2-5 7 of the seven guidelines agree that X-Ray is indicated as an initial
assessment to assess suspected dislocation2-5 7. The ACC guideline5 more
specifically recommends X-Ray following reduction or failed reduction, pre
reduction in all >40years and in recurrent dislocation when surgery being
considered.
US
Only one guideline2 recommends the use of US; this is to assess the RC in
patients >40 years with primary traumatic dislocation. The remaining
guidelines recommend MRI to identify full or partial thickness tears to the RC.
It would seem appropriate given the cost effectiveness of US to consider this as
first line in patients >40yrs; where MRI would not other wise be planned.
Advanced imaging
All seven guidelines recommend the use of advanced imaging
MRI/MRA All guidelines1-7 are in general agreement that MRI/MRA are most appropriate
for imaging of the soft tissues associated with the GH joint. ACC5 and
RANZCR7 recommend that MRI is indicated for investigation of GH joint soft
tissues and instability, however they both go on to state that MRA best
evaluates and provides more accurate appraisal of these tissues. MRI
2
recommended for suspected partial RC tears . MRA is advocated where there is
suspected Labral tears with or without associated instability1-3 5 6
There is some ambiguity around which setting MR should be combined with
arthrogaphy. The guidelines suggest that:
Accident Compensation Corporation
Page 8
CT
ƒ
MRI is more appropriate for the acute setting
ƒ
MRA is most appropriate in the sub-acute/chronic setting
CT indicated where MRI/MRA unavailable2 6 7. CT particularly useful to
delineate glenoid labrum and synovial cavity, will show bony glenoid and
13
cartilaginous tears .
ACC clinical directorate agree with recommendation; in addition it is felt
pertinent to clarify that labral tears may exist without instability. Further
investigation of presentation and recommended imaging of SLAP lesions is also
recommended for inclusion in the guideline.
3. Significant Shoulder/Glenohumeral Joint Trauma (e.g. dislocation, fracture)
X-ray
X-Ray indicated when patient history, signs and symptoms raise clinical
suspicion of fracture/dislocation
ACC clinical directorate agree – no amendment
Five2 4-7 of the seven guidelines include this condition; there is agreement across
all guidelines that if patient history is suggestive of fracture/dislocation, X-ray
is indicated. Note that the ACC guideline says that the diagnostic value is
unclear, but advocates X-ray pre- and post-reduction.
4
US recommended to assess soft tissue involvement
Advanced Imaging
CT indicated for complex fractures and fracture-dislocations involving the
head of the humerus2 7 and for surgical planning7.
ACC clinical directorate agree with recommendation and feel it is pertinent to
add that it is clinically appropriate in those patients aged >50 years to use a
follow up bone scan to assess bony healing. Bone scans are not covered by
ACC
4. Acromio-clavicular joint disorders
AC joint disorders can be categorised as acute and chronic
X-ray
X-ray indicated when surgery is a consideration and when there is a history of
trauma to stage degree of severity.
ACC clinical directorate agree with recommendation – no amendment
145
Three of the guidelines included AC joint disorders. There is general
agreement that X-Ray is only indicated where there is a history of trauma and
when surgery is being considered. The online diagnostic imaging pathways
2
(Dept of health, Western Australia) doesn’t specifically include AC joint
disorders but indicates X-Ray as the first choice of imaging for all general
shoulder trauma.
US indicated to assess subacromial & AC joint impingement.
Accident Compensation Corporation
Page 9
Advanced imaging
MRI indicated to assess the joint; for acute separations grade I-III, for chronic
AC joint disorders and when there is no response 4 weeks conservative
treatment. US/CT appropriate where MRI contraindicated/unavailable. CT
indicated when # is detected &/or surgery being considered
ACC clinical directorate agree with recommendation – no amendment
Two1 4 of the guidelines include detail on advanced imaging. They each address
different clinical sub categories of AC joint disorders, together contributing to
form a complete recommendation. Bussieres4 state that MRI is more sensitive
to grade I-III separations and also allows assessment of other structures
simultaneously; however it does not implicitly recommend that MRI is
necessary if grade I-III separation is suspected. The guideline does recommend
MRI or CT preoperatively and where pathology is suspected. The European
1
guideline recommends the use of US for AC and sub acromial impingement,
however as impingement is dynamic process, discussion with a radiologist is
highly recommended.
5. Sternoclavicular Joint Disorders (injuries are uncommon; resulting from compression forces in
MVA’s & Sport)
Recommendation Based on the strength of the evidence behind the existing
guideline recommendations: X-Ray indicated
X-ray
Only one of the guidelines5 specifically included this condition. Two other
guidelines covered the condition under acute shoulder pain6 or shoulder
trauma2. ACR appropriateness critieria6 and the online diagnostic imaging
pathways (Dept of Western Australia)2 agree that X-Ray should be the initial
investigation. The ACC 2004 guideline5 suggests that X-Ray is not ideal for
imaging the SC joint as it can often be difficult to interpret.
The two guidelines recommending X-Ray2 6 don’t include detail about the grade
of recommendation. However closer inspection of the guideline development
256
process for all three of the guidelines reveals comparable methodologies and
levels of evidence. The ACC5 recommendation is based on expert opinion
which is presumably that of NZ experts and is therefore realistic to the target
audience of the guideline being currently developed.
Advanced imaging
CT indicated for further investigation when X-Ray non-contributory and/or
pain persistent
5
ACC 2004 recommends CT as the best image for this condition. This
recommendation is supported by that made in the online diagnostic imaging
pathways (Dept of Western Australia)2 recommendation that if fracture is
detected/suspected CT is indicated. ACR appropriateness criteria6 recommend
MRI when X-Ray is non- contributory; the guideline also recommends that CT
or US may be appropriate when MRI is contraindicated.
Accident Compensation Corporation
Page 10
ACC clinical directorate agree with overall recommendation. In addition; in
cases where aetiology suggests the clavicle may have been pushed posteriorly,
immediate referral and further investigation are indicated
Grades of Recommendations
The Grading system adapted and used in the previous ACC guideline5 was used and the
other guideline grading categories were aligned to this. The ACC grades are outlined
below:
A
Recommendation is supported by good evidence
B
Recommendation is supported by fair evidence
C
Recommendation is supported by expert opinion only e.g published consensus
document
I
No recommendation can be made because the evidence is insufficient i.e evidence
is lacking, of poor quality or conflicting and the balance of benefits and harms
cannot be determined
Grades of recommendations and levels of evidence for the remaining guidelines is
included in the appendix.
Pregnancy and protection of the foetus
Three1 2 6 of the seven reviewed guidelines include information regarding imaging during
pregnancy & the potential for harm to the foetus. One of the guidelines4 includes general
information about the potential for harm inherent with imaging techniques that involve
ionising radiation (IR). It is recommended to include this in the updated HTI referral
guideline.
Bussieres include general information about the risk of ionising radiation inherent in
imaging. The guideline suggests that the benefit of the image must outweigh the risk and
the result of the image must influence therapy and treatment outcome.
1-3
The three guidelines that specifically address protection of the foetus agree that if
pregnancy cannot be excluded; the referring clinician should discuss the planned image
with the radiologist with a view to potentially postponing until after the pregnancy or until
pregnancy can be excluded unless the image will directly benefit the foetus. Exposure to
ionising radiation (IR) (X-Ray & CT) should be avoided where possible during
pregnancy1-3. If X-Ray or CT is deemed necessary the modality with the lowest level of
ionising radiation should be chosen; consideration should be given to US and MRI which
involve no exposure to IR.
Application of the 28 day rule is advocated: if a period has been missed wait until
pregnancy has been excluded before going ahead with planned image.
In all cases requiring imaging the ARLA (As Low as Reasonably Appropriate) principle
presented by the online diagnostic imaging pathway (Department of health, Western
Australia)2 should be applied.
Accident Compensation Corporation
Page 11
ACC clinical directorate agree. This should be expanded to notes on health and safety to
include pacemakers and implants.
CT & MRI images may be degraded by prostheses or internal fixation devices1 3 7.
Contraindications to MRI are; metallic foreign bodies (FB’s) in the orbits, aneurysm clips,
pacemakers, cochlear implants1 3 7, stents inserted in the previous six weeks and marked
7
obesity . Patients may be intolerant of remaining stationary and/or being in an enclosed
space and would therefore potentially be contraindicated for CT and MRI.
Accident Compensation Corporation
Page 12
Summary of findings
Agreement of guidelines: There was agreement, or near agreement, about imaging
assessment of:
•
Patient Category 2: i) Rotator Cuff disorders (tendinopathy) (however, although it
is agreed that MRI arthrography is appropriate and highly accurate, there is some
ambiguity about whether it should be first line assessment);
•
Patient Category 2: v) Glenohumeral joint instability (however, although it is
agreed that MRI and MRI arthrography is appropriate, there is ambiguity about its
indication for acute, sub-acute and chronic);
•
Patient Category 3: Significant glenohumeral joint trauma (dislocation, fracture);
•
Patient Category 4: Acromio-clavicular Joint disorders;
•
Patient Category 5: Sternoclavicular Joint Disorders.
Ambiguity of guidelines: There was ambiguity about imaging assessment of:
•
Patient Category 1: Non-traumatic shoulder pain, and full or limited movement
(i.e. ACC clients with non-specific shoulder pain) - specifically there is a lack of
clarity in 2 of the guidelines2 6; the recommendation is that ‘X-Ray is the best initial
study’, its does not state whether this is at initial assessment or just that X-Ray
should be the first study of choice when imaging investigation is clinically
warranted.
•
Patient Category 2i): Rotator Cuff disorders – whether MRI or US should be the
first choice of investigation for suspected RC tears. US more cost effective but not
sensitive to partial tears. If US is first choice but is inconclusive then MRI is used
does that remove the cost effectiveness of US
•
Patient Category 2v): Glenohumeral instability (Lack of clarity across guidelines
about appropriate use/indication for MRA)
Irrelevent to ACC: Patient Category 2(iv).
Quality of Evidence: Six1-6 of the seven reviewed guidelines appear to be of good quality
and have been produced following a robust methodology. The remaining guideline7
appears to be based more on consensus expert opinion and lacks a good quality evidence
base.
Limitation of the analysis: it is possible that the some of the ambiguities may be an
artefact of the analysis and interpretation of the guidelines due to the fact that the scope of
guidelines and descriptions used for ‘patient presentation’ are slightly different.
Accident Compensation Corporation
Page 13
References
1. Commission E. Radiation Protection 118: Referral guidelines for imaging. Luxembourg,
2000.
2. Department of Health Western Australia. Diagnostic imaging pathways (online decision
support tool) (http://www.imagingpathways.health.wa.gov.au/Includes/). Perth:
Department of Western Australia, 2007.
3. The Royal College of Radiologists. Making the best use of clinical radiology services:
referral guidelines. London: The Royal College of Radiologists, 2007.
4. Bussieres AE, Peterson C, Taylor JAM. Diagnostic Imaging Guideline for
Musculoskeletal Complaints in Adults :An evidence-based approach Part 2: Upper
Extremity Disorders. Journal of Manipulative and Physiological Therapeutics
2008;31:2-32.
5. Accident Compensation Corporation. The Diagnosis and Management of Soft Tissue
Shoulder Injuries and Related Disorders: Best Practice Evidence-Based Guideline.
Wellington: ACC, 2004.
6. Wise JN, et al American College of Radiology, ACR Appropriateness Criteria; Acute
shoulder pain. Lexington, Kentucky, 2010.
7. Lau LSW, editor. Imaging Guidelines. 4th ed: The Royal Australian and New Zealand
College of Radiologists (RANZCR), 2001.
Appendix
1. Link to Xcel spreadsheet of key data from the seven included guidelines:
2Natcomparison of existing guidelines.xls
2. Grades of recommendations by guideline
Bussieres et al 20084
Based on the SIGN guideline development of grades.
Grades of Recommendations
A
Requires at least one RCT as part of a body of literature of overall good quality
and consistency addressing the specific recommendation. (Evidence levels Ia, Ib).
This is consistent with ACC grade A
B
Requires the availability of well conducted clinical studies but no RCT’s on the
topic of recommendation. (Evidence levels IIa, IIb, III). This is consistent with
ACC grade B
C
Requires evidence obtained from expert committee reports or opinions and/or
clinical experiences of respected authorities. Indicates an absence of directly
applicable clinical studies of good quality. (Evidence level IV). This is consistent
with ACC grade C
D
Requires evidence level III or IV or extrapolate evidence from level II+ studies This is consistent with ACC grade C
Accident Compensation Corporation
Page 14
ACC (2004)5
Levels of evidence
1++ High quality meta-analyses systematic reviews of RCT’s or RCT’s with low risk of
bias
1+ Well conducted meta-analyses, systematic reviews of RCT’s or RCT’s with low
risk of bias
1-
Well conducted meta-analysis, systematic reviews of RCT’s or RCT’s with high
risk of bias
2++ High quality systematic reviews of case control or cohort studies
High quality case control or cohort studies with a low risk of confounding, bias,
or chance and high probability that the relationship is causal
2+ Well conducted case control or cohort studies with a low risk of confounding,
bias, or chance and moderate probability that the relationship is causal
2-
Case control or cohort studies with a high risk of confounding, bias, or chance
and significant risk that the relationship is not causal
3
Non-analytical studies, eg, case reports, case series
4
Expert opinion eg narrative reviews, expert panel
Further levels of evidence for diagnostic tests
Single diagnostic studies
D++ Good
D+ Fair
D- Poor
Diagnostic systematic review
DSR++ High quality meta-analysis or systematic review of diagnostic studies
DSR+ Fair quality meta-analysis or systematic review of diagnostic studies
DSR-
Poor quality meta-analysis or systematic review of diagnostic studies
Accident Compensation Corporation
Page 15
Grades of recommendation (to be used to grade current referral guideline)
A
Recommendation is supported by good evidence
B
Recommendation is supported by fair evidence
C
Recommendation is supported by expert opinion only e.g published consensus
document
I
No recommendation can be made because the evidence is insufficient i.e evidence
is lacking, of poor quality or conflicting and the balance of benefits and harms
cannot be determined
ACR (2010)6Recommendations are not graded in this guideline. The categories detailed
below guided the overall recommendations.
Levels of evidence
CODE
1
CATEGORY NAME
Category 1
2
Category 2
3
Category 3
4
Category 4
CATEGORY DEFINITION
The conclusions of the study are valid and strongly supported by study
design, analysis and results.
The conclusions of the study are likely valid, but study design does not
permit certainty.
The conclusions of the study may be valid but the evidence supporting the
conclusions is inconclusive or equivocal.
The conclusions of the study may not be valid because the evidence may not
be reliable given the study design or analysis.
Based on levels of evidence the expert group then assigned recommendations based on the
categories below. Consensus of expert opinion guided the final recommendations.
Category Name and Definition
Diagnostic Procedures
RATING
7, 8, or 9
CATEGORY NAME
Usually appropriate
4, 5, or 6
May be appropriate
CATEGORY DEFINITION
The study or procedure is indicated in certain clinical
settings at a favourable risk-benefit ratio for patients, as
supported by published peer-reviewed scientific studies,
supplemented by expert opinion.
The study or procedure may be indicated in certain clinical
settings, or the risk-benefit ratio for patients may be
equivocal as shown in published peer-reviewed, scientific
Accident Compensation Corporation
Page 16
studies, supplemented by expert opinion.
1, 2, or 3
Usually not appropriate
Unrated
No Consensus
Under most circumstances, the study or procedure is
unlikely to be indicated in these specific clinical settings, or
the risk-benefit ratio for patients is likely to be
unfavourable, as shown in published peer-reviewed,
scientific studies supplemented by expert opinion.
Either high quality, relevant clinical studies are not
available or are inconclusive, or expert consensus could not
be reached regarding the use of this study/ procedure for
this clinical scenario.
Western Australia Department of Health2
Each study is graded using the Oxford Centre for Evidence-Based Medicine levels of
evidence for diagnostic tests. Evidence is graded from Levels I to V, as follows:
•
Level I: Validating cohort study with good reference standards or systematic review
of validating cohort studies.
•
Level II: Exploratory cohort study with good reference standards or systematic
review of exploratory cohort studies.
•
Level III: Non-consecutive study or without consistently applied reference
standards.
•
Level IV: Case control study, poor or non-independent reference standard.
•
Level V: Expert opinion without explicit critical appraisal, or based on physiology,
bench research or "first principles".
Grades of recommendation were not used but levels of evidence were mainly I-III
3
Royal College of Radiologists, London (2007)
Grades of recommendation based on USA department of health and human services
agency for healthcare, policy and research (SIGN based on this system)
A – Any of the following; High quality diagnostic studies in which a new test is
independently and blindly compared with a reference standard in an appropriate spectrum
of patients, Systematic review and meta-analyses of such high-quality studies, Diagnostic
clinical practice guidelines/clinical decision rules validated in a test set - This is consistent
with ACC grade A
B - Any of the following; Studies with blind and independent comparison of the new test
with the reference standard in a set of non-consecutive patients or confined to a narrow
spectrum of patients, Studies in which reference standard was not applied to all patients,
Systematic review of such studies, Diagnostic clinical practice guidelines/clinical decision
rules not validated in a test set - This is consistent with ACC grade B
Accident Compensation Corporation
Page 17
C – Any of the following; Studies in which the reference standard was not objective,
Studies in which the comparison of the new test with the reference standard was not blind
or independent, Studies in which positive and negative test results were verified using
different reference standards, Studies using an inappropriate set of patients, Expert
opinion - This is consistent with ACC grade C
European Guidelines1
Grades of recommendation are based on the National Health Service (NHS), UK guideline
policy. The strength of the evidence for the various statements is indicated by:
A - Randomised controlled trials (RCTs), meta analyses, systematic reviews - This is
consistent with ACC grade A
B - Robust experimental or observational studies - This is consistent with ACC grade B
C - Other evidence where the advice relies on expert opinion and has the endorsement of
respected authorities - This is consistent with ACC grade C
Accident Compensation Corporation
Page 18