Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence

DJ Hunter; W Zhang; PG Conaghan; K Hirko; L Menashe; WM Reichmann; E Losina

doi:10.1016/j.joca.2010.10.030

. Author manuscript; available in PMC: 2013 Apr 15.

Published in final edited form as: Osteoarthritis Cartilage. 2011 Mar 23;19(5):589–605. doi: 10.1016/j.joca.2010.10.030

Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence

DJ Hunter ^†,^‡,^*, W Zhang ^§, PG Conaghan ^‖, K Hirko ^‡, L Menashe ^‡, WM Reichmann ^¶, E Losina ^¶

PMCID: PMC3625963 NIHMSID: NIHMS348902 PMID: 21396465

SUMMARY

Objective

To summarize literature on the responsiveness and reliability of MRI-based measures of knee osteoarthritis (OA) structural change.

Methods

A literature search was conducted using articles published up to the time of the search, April 2009. 1338 abstracts obtained with this search were preliminarily screened for relevance and of these, 243 were selected for data extraction. For this analysis we extracted data on reliability and responsiveness for every reported synovial joint tissue as it relates to MRI measurement in knee OA. Reliability was defined by inter- and intra-reader intra-class correlation (ICC), or coefficient of variation, or kappa statistics. Responsiveness was defined as standardized response mean (SRM) - ratio of mean of change over time divided by standard deviation of change. Random-effects models were used to pool data from multiple studies.

Results

The reliability analysis included data from 84 manuscripts. The inter-reader and intra-reader ICC were excellent (range 0.8–0.94) and the inter-reader and intra-reader kappa values for quantitative and semi-quantitative measures were all moderate to excellent (range 0.52–0.88). The lowest value (kappa = 0.52) corresponded to semi-quantitative synovial scoring intra-reader reliability and the highest value (ICC = 0.94) for semi-quantitative cartilage morphology.

The responsiveness analysis included data from 42 manuscripts. The pooled SRM for quantitative measures of cartilage morphometry for the medial tibiofemoral joint was −0.86 (95% confidence intervals (CI) −1.26 to −0.46). The pooled SRM for the semi-quantitative measurement of cartilage morphology for the medial tibiofemoral joint was 0.55 (95% CI 0.47–0.64). For the quantitative analysis, SRMs are negative because the quantitative value, indicating a loss of cartilage, goes down. For the semi-quantitative analysis, SRMs indicating a loss in cartilage are positive (increase in score).

Conclusion

MRI has evolved substantially over the last decade and its strengths include the ability to visualize individual tissue pathologies, which can be measured reliably and with good responsiveness using both quantitative and semi-quantitative techniques.

Keywords: Osteoarthritis, Magnetic resonance imaging, Reliability, Responsiveness

Introduction

One proposed osteoarthritis (OA) treatment goal is modification of the underlying joint structure. Highly reproducible and responsive measures of the rate of disease progression are a prerequisite for assessing structural change in clinical trials. Conventional radiography (CR) has been the mainstay of assessing structural change in OA clinical trials and is currently part of FDA recommendations on how to conduct trials to assess structural progression. The focus of such evaluations has been on the radiographic joint space as a surrogate for hyaline cartilage assessment.

There has been a growing awareness that symptomatic OA represents a process involving all the tissues in the OA joint. Structure modification should therefore be considered in a broader context than that of cartilage alone. Modern imaging, especially magnetic resonance imaging (MRI), allows unparalleled direct visualization of all the tissues involved in OA joint pathology, including cartilage, menisci, subchondral bone and soft tissue. MRI is ideally suited for imaging arthritic joints as is it is free of ionizing radiation, and its tomographic viewing perspective obviates morphological distortion, magnification and superimposition. More importantly, MRI has a rich image contrast variability resulting in an ability to discriminate articular tissues and it therefore holds great potential as a tool for whole-organ imaging of the OA joint. The last 20 years has seen a rapid improvement in imaging technology and in the last decade this has translated into improved understanding of the importance of individual features, their relation to clinical outcome and disease pathogenesis and better data on the quantification of these pathologies^1,2. There is a wealth of literature on the measurement properties of MRI in the setting of OA including responsiveness and reliability. Prior to considering the merits of MRI in the setting of potential disease modifying trials and trial guidance it is important to review this systematically.

The objective of this review was to summarize the literature on the responsiveness and reliability of MRI-based measures of knee OA structural change.

Material and methods

Systematic literature search details

An online literature search was conducted using the OVID MEDLINE (1945–), EMBASE (1980–) and Cochrane databases (1998–). The search was not limited by publication date and the last search occurred in April 2009, with the search entries “MRI”, and “osteoarthritis”, “osteoarthritides”, “osteoarthrosis”, “osteoarthroses”, “degenerative arthritis”, “degenerative arthritides”, or “osteoarthritis deformans”. The abstracts of the 1330 citations received with this search were then preliminarily screened for relevance by two reviewers (KH and DJH). Although review articles were not included (see Inclusion/exclusion criteria), citations found in any review articles which were not already included in our preliminary search were screened for possible inclusion in this study. This added seven more relevant studies to our search. One further article was added, before publication, by one of the authors of this meta-analysis bringing the preliminary total to 1338.

Inclusion/exclusion criteria

Only studies published in English were included. Studies presenting non-original data were excluded, such as reviews, editorials, opinion papers, case studies or letters to the editor. Studies with questionable clinical relevance and those using non-human subjects or specimens were excluded. Studies in which rheumatoid, inflammatory, or other forms of arthritis were included in the OA datasets were excluded, as well as general joint-pertinent MRI studies not focused on OA. Studies with no extractable, numerical data were excluded. Any duplicates which came up in the preliminary search were excluded. Of the preliminary 1338 abstracts, 243 were selected for data extraction (Fig. 1).

Fig. 1 — Flow chart of the screening process for articles included in the systematic review.

Data abstraction

We used a data abstraction tool constructed in EpiData (Entry version 2.0 Odense, Denmark). Two reviewers (KH and LM) independently abstracted the following data: (1) patient demographics; (2) MRI make (vendor and field strength), sequences and techniques used (see further description below), tissue types viewed; (3) study type and funding source; (4) details on rigor of study design to construct the Downs methodological quality score (see further description below)³; (5) MRI reliability/reproducibility data; (6) MRI diagnostic measures and performance; (7) gold standard measures against which the MRI measure was evaluated; (8) treatment and MRI measures (when appropriate).

Multiple techniques have been used to measure structural abnormality and change on MRI in OA. Broadly speaking these methods are divided into quantitative and semi-quantitative methods¹. Quantitative measurements using computer-aided image processing to assess whole joint quantification (cartilage morphometry, bone volume, bone marrow lesion volume, meniscal position and volume, synovial volume, etc). The three-dimensional (3D) coverage of an entire cartilaginous region by MRI allows for the direct quantification of volumetric structures. Compositional measures of articular cartilage are also included within the quantitative measures as the measurement provides for a quantitative output. These methods include T2mapping, dGEMRIC and T1rho and are extensively reviewed elsewhere^4,5.

In contrast to quantitative measures semi-quantitative image analysis is typically much more observer dependent and generates grades or scales rather than truly continuous output. Semi-quantitative scoring of MRI’s are a valuable method for performing multi-feature assessment of the knee using conventional MRI acquisitions^6–8,98. Such approaches score, in an observer dependent semi-quantitative manner, a variety of features that are currently believed to be relevant to the functional integrity of the knee and/or potentially involved in the pathophysiology of OA. These articular features can include articular cartilage morphology, subarticular bone marrow abnormality, subarticular cysts, subarticular bone attrition, marginal and central osteophytes, medial and lateral meniscal integrity, anterior and posterior cruciate ligament integrity, medial and lateral collateral ligament integrity, synovitis/effusion, intra-articular loose bodies, and periarticular cysts/bursitis.

The Downs methodological quality score³ collects a profile of scores (quality of reporting, internal validity (bias and confounding), power, external validity so that the overall study quality score reflects all of these elements. Answers were scored 0 (No) or 1 (Yes), except for one item in the Reporting subscale, which scored 0–2 and the single item on power, which was scored 0–5. The possible range is from0–27 where 0 represents poor quality and 27 optimal quality.

The outcomes for psychometric properties on MRI were examined using the OMERACT filter^10,11. The material pertinent to this manuscript is Discrimination: does the measure discriminate between situations that are of interest? The situations can be states at one time (for classification or prognosis) or states at different times (to measure change). This criterion captures the issues of reliability and responsiveness (sensitivity to change).

Statistical analysis

Reliability was defined by inter- and intra-reader measures of coefficient of variation (CV), or intra-class correlation (ICC), or kappa statistics.

Responsiveness was defined as standardized response mean (SRM) - ratio of mean of change over time divided by standard deviation of change. Whenever possible, both reliability measures and SRMs were stratified by measurement method (quantitative and semi-quantitative), tissue lesion (cartilage, synovium, bone, bone marrow lesions, meniscus and ligament) and plate/region for cartilage divisions.

For the quantitative analysis, a negative SRM expresses cartilage loss whereas a positive SRM would indicate cartilage gain. For the semi-quantitative analysis, positive SRMs indicate a loss in cartilage with higher scores reflecting greater lesions.

Random-effects models were used to summarize data from multiple studies. Since some studies reported more than one measure for each region, to avoid substantial skewness of results influenced by multiple observations from a single study and to ensure that the estimates included in the analysis came from independent studies, we repeated analyses 500 times. We did this by selecting one observation (estimate) from each study at random so that the number of observations in the model reflected the number of studies. We then ran a random-effects model to obtain the pooled summary measure and its standard error. The process was repeated 500 times to obtain the empirical distribution of the summary measure. The final pooled summary measure and its standard error were obtained by averaging the 500 summary measures and the 500 standard errors obtained from the random-effects models respectively. Ninety-five percent confidence intervals (CI) were obtained using a normal approximation for the final pooled summary measure and its standard error.

Results

Reliability

The reliability analysis included data from 84 manuscripts (Table I). The mean Downs criteria score for these manuscripts was 9.4 (range 4–16).

Table I.

Summary table of studies reporting data on reliability of MRI in knee OA

Reference: Author, Journal, Year, PMID	Whole sample size	No. of cases	No. of controls	Age, yrs, mean (SD), range	No. (%) of females	Quantitative	Compositional techniques	Semi- quantitative	Cartilage	Synovium	Bone	Bone marrow lesions	Meniscus	Ligament	Study design	Downs criteria score
Karvonen RL; Journal of Rheumatology; 1994; 7966075¹³	92	52	40	All OA Pts: 55(14), (Range: 25–86); Bilateral OA Pts: 53(13) (Range: 25–73); Control: 49(15), (Range: 22–78)	All OA Pts: 35; Bilateral OA Pts: 19; Control: 25	X			X		X				Case control	11
Peterfy CG; Radiology; 1994; 8029420¹⁴	8	5	3	62 (Range: 45–82)	4(50%)	X			X						Cross- sectional	4
Marshall KW; Journal of Orthopaedic Research; 1995; 8544016¹⁵	2			31		X			X						Other	6
Disler DG; AJR Am J Roentgel.; 1996; 8659356¹⁶	114	79	35	36	48			X	X						Cross- sectional	6
Dupuy DE; Academic Radiology; 1996; 8959181¹⁷	7	2	5	TKA Pts: (Range: 64–75); Asymptomatic Pts: (Range: 25–35)	TKA Pts: 1(50%); Asymptomatic Pts: 2	X			X						other	6
Trattnig S; Journal of Computer Assisted Tomography; 1998; 9448754¹⁸	20	20	0	72.2 (Range: 62–82)	18			X	X						Other	8
Drape JL; Radiology; 1998; 9646792¹⁹	43	43	0	63 (Range: 53–78)	30			X	X						Cross- sectional	5
Cicuttini F; Osteoarthritis & Cartilage; 1999; 10329301²⁰	28			Males: 41.4(14.8); Females: 31.2(8.6)	11(39%)	X			X						Cross- sectional	7
Pham XV; Revue du Rhumatisme; 1999; 10526380²¹	10	10	10	67.2(7.34), (Range: 57–80)	6			X						X	Cross- sectional	13
Gale DR; Osteoarthritis & Cartilage; 1999; 10558850²²	291	233	58	Men cases: 67(10); Men controls 65(10); Women cases: 66(10); Women controls: 66(8)	61(21%)								X		Case control	10
Hyhlik–Durr A; European Radiology; 2000; 10663760²³	11	3	8	OA group: (Range: 61–75); Healthy group:	5(45.5%)	X			X						Cross- sectional	6
Jones G; Arthritis & Rheumatism; 2000; 11083279²⁴	92	0	92	Boys:12.8(2.7); Girls: 12.6(2.9)	43(46.8%)	X			X		X				Cross- sectional	13
Wluka AE; Annals of the Rheumatic Diseases; 2001; 11247861²⁵	81	42	39	Cases: 58(6.1); Controls: 56(5.4)	81(100%)	X		X	X						Case control	16
Felson DT; Annals of Internal Medicine; 2001; 11281736²⁶	401	401	0	66.8				X				X			Cross- sectional	13
Hill CL; Journal of Rheumatology; 2001; 11409127²⁷	458	433	25	67	(34%)			X		X					Case control	13
Bergin D; Skeletal Radiology; 2002; 11807587²⁸	60	30	30	Cases: 50; Controls: 57				X					X	X	Case control	9
Beuf O; Arthritis & Rheumatism; 2002; 11840441²⁹	46	18	28	Mild OA: 56.3(4.5); Severe OA: 70(6.3)	17(37%)	X									Case control	5
Wluka AE; Arthritis & Rheumatism; 2002; 12209510³⁰	123	123	0	63.1(10.6)	71	X			X		X				Longitudinal Prospective	14
Gandy SJ; Osteoarthritis & Cartilage; 2002; 12464553³¹	16	16	0		6	X			X						Longitudinal Prospective	8
Bhattacharyya T; Journal of Bone & Joint Surgery - American Volume; 2003; 12533565³²	203	154	49	Cases: 65; Controls: 67				X					X		Case control	9
Cicuttini FM; Clinical & Experimental Rheumatology; 2003; 12673893³³	81	42	39	ERT: 58(6.1); Controls: 56(5.4)	81(100%)	X			X		X				Case control	12
Raynauld JP; Osteoarthritis & Cartilage; 2003; 12744941³⁴	28	17	11	Healthy subjects: (Range: 25–35); OA Pts: 63.5		X			X						Other	7
Felson DT; Annals of Internal Medicine; 2003; 12965941³⁵	256	256	0	Followed: 66.2(9.4); t followed: 67.8(9.6)	Followed: 41.7%; t followed: 15.2%			X				X			Other	11
Hill CL; Arthritis & Rheumatism; 2003; 14558089³⁶	451	427		Knee pain/ROA/MALE: 68.3; Knee pain/ROA/ Female: 65; knee pain/ ROA/male: 66.8; knee pain/ROA/ female:66.1				X				X			Cross-s ectional	10
Glaser C; Magnetic Resonance in Medicine; 2003; 14648571³⁷	23	7	16	Healthy subjects: (Range: 23–33);	13(56.5%)	X			X						Cross- sectional	5
Lindsey CT; Osteoarthritis & Cartilage; 2004; 14723868³⁸	74	33	21	OA1(KL = 1/2):62.7(10.9); OA2(KL = 3/4):66.6(11.6); Controls: 34.2(12.5)	39(52.7%)	X			X		X				Case control	8
Cicuttini FM; Arthritis & Rheumatism; 2004; 14730604³⁹	117	117		63.7(10.2)	(58.1%)	X			X						Longitudinal Prospective	9
Raynauld JP; Arthritis & Rheumatism; 2004; 14872490⁴⁰	32	32	0	62.9(8.2)	(74%)	X			X						Longitudinal Prospective	10
Cicuttini F; Rheumatology; 2004; 14963201⁴¹	117	117	0	67(10.6)	(58.1%)	X			X						Longitudinal Prospective	12
Peterfy CG; Osteoarthritis & Cartilage; 2004; 14972335⁶	19	19	0	61(8)	4			X	X	X	X	X	X	X	Other	5
Dashti M; Scandinavian Journal of Rheumatology; 2004; 15163109⁴²	174	117	57	61.6(9.5)	123(70.7%)	X			X						Case control	11
Cicuttini FM; Journal of Rheumatology; 2004; 15229959⁴³	102	102	0	63.8(10.1)	(63%)	X			X						Longitudinal Prospective	10
Baysal O; Swiss Medical Weekly; 2004; 15243849⁴⁴	65	65	0	53.1(7), (Range: 45–75)	(100%)	X		X	X		X				Cross- sectional	7
Kornaat PR; Skeletal Radiology; 2005; 15480649⁹	25	25	0	Median age = 63, (Range: 50–75)				X	X	X	X	X	X		Other	6
Yoshioka H; Journal of Magnetic Resonance Imaging; 2004; 15503323⁴⁵	28	28	0	55.6 (Range: 40–73)	10	X		X	X	X		X	X		Other	5
Ding C; Osteoarthritis & Cartilage; 2005; 15727885⁴⁶	372	162	210	cartilage defects: 43.6(7.1);	(58%)	X		X	X						Case control	9
Hill CL; Arthritis & Rheumatism; 2005; 15751064⁴⁷	433	360	73	Case males:68.2; Case females:65; Control males:66.8; Control females:65.8	143(33%)			X						X	Case control	12
Maataoui A; European Radiology; 2005; 15856246⁴⁸	12	12	0	median age = 70.5, (Range: 60–86)	9	X			X						Cross- sectional	6
Cicuttini F; Osteoarthritis & Cartilage; 2005; 15922634⁴⁹	28	28	0	62.8(9.8)	(57%)	X			X						Longitudinal Prospective	10
Huh YM; Korean Journal of Radiology; 2005; 15968151⁵⁰	94	73	21	OA group: 57.8, (Range: 40–80), Median = 58; RA group:49.6, (Range: 37–76), Median = 48	73(80%)			X		X					Longitudinal Retropective	7
Wluka AE; Rheumatology; 2005; 16030084⁵¹	126	126	0	63.6(10.1)	68(54%)	X		X	X		X				Longitudinal Prospective	14
Eckstein, F; Annals of the Rheumatic Diseases; 2006; 16126797⁵²	19	10	9	51 (Range: 40–71)	12	X			X		X				Other	8
Eckstein F; Arthritis & Rheumatism; 2005; 16200592⁵³	30	15	15	Cases: 49.6(Range: 37–76); Controls: 62.3(11.5)	30(100%)	X			X						Cross- sectional	7
Sengupta M; Osteoarthritis & Cartilage; 2006; 16442316⁵⁴	217	217	0	67.3(9.1)	(30%)			X	X	X	X	X			Cross- sectional	7
Raynauld JP; Arthritis Research & Therapy; 2006; 16507119⁵⁵	110	110	0	62.4(7.5)	(64%)	X		X	X			X	X		Longitudinal Prospective	11
Hunter DJ; Arthritis & Rheumatism; 2006; 16508930⁵⁶	257	257	0	66.6(9.2), (Range: 47–93)	(41.6%)			X	X				X		Longitudinal Prospective	10
Brandt KD; Rheumatology; 2006; 16606655⁵⁷	30	20	10	62	29					X					Other	10
Jaremko JL; Osteoarthritis & Cartilage; 2006; 16644245⁵⁸	12	3	9	OA: (Range: 59–71); ) Healthy: 37(8), (Range: 23–48)	4(33.3%)	X			X						Cross- sectional	8
Hunter DJ; Osteoarthritis & Cartilage; 2007; 16857393⁵⁹	127	127		67(9.05)	(46.7%)		X		X						Cross- sectional	12
Boks SS; American Journal of Sports Medicine; 2006; 16861575⁶⁰	134	136	132	40.8 (Range: 18.8–63.8)				X	X				X	X	Cross- sectional	7
Brem MH; Skeletal Radiology; 2007; 17219231⁶¹	5	5	0	64.3 (Range: 40–73)	2	X			X						Other	6
Folkesson J; IEEE Transactions on Medical Imaging; 2007; 17243589⁶²	139			56 (Range: 22–79)	(59%)	X			X						Other	7
Dam EB; Osteoarthritis & Cartilage; 2007; 17353132⁶³	139			Evaluation set: 55(Range: 21–78);	(55%)	X			X						Other	9
Baranyay FJ; Seminars in Arthritis & Rheumatism; 2007; 17391738⁶⁴	297		297	58(5.5)	(63%)	X			X			X			Cross- sectional	16
Hanna F; Mepause; 2007; 17413649⁶⁵	176	0	176	52.3(6.6), (Range: 40–67)	176(100%)	X			X						Cross- sectional	13
Hunter DJ; Annals of the Rheumatic Diseases; 2008; 17472995⁸	71			67.9(9.3)	(28.2%)			X	X	X	X	X	X	X	Other	8
Hill CL; Annals of the Rheumatic Diseases; 2007; 17491096⁶⁶	270	270	0	66.7(9.2)	112			X	X	X					Longitudinal Prospective	9
Qazi AA; Osteoarthritis & Cartilage; 2007; 17493841⁶⁷						X			X						Cross- sectional	8
Guymer E; Osteoarthritis & Cartilage; 2007; 17560134⁶⁸	176	0	176	52.3(6.6)	(100%)	X		X	X		X				Cross- sectional	11
Eckstein F; Osteoarthritis & Cartilage; 2007; 17560813⁶⁹	9	9		52.2(9.3)	5	X			X						Other	9
Akhtar, S; Osteoarthritis & Cartilage; 2007; 17707660⁷⁰	6			(Range: 25–69)	2(33%)	X			X						Other	7
Raynauld JP; Annals of the Rheumatic Diseases; 2008; 17728333⁷¹	107	107	0	62.4(7.5)	(64%)	X		X	X				X		Longitudinal Retropective	15
Felson DT; Arthritis & Rheumatism; 2007; 17763427⁷²	330	110	220	Cases: 62.9(8.3); Controls: 61.2(8.4)	211(64%)			X			X	X			Case control	12
Lo GH; Osteoarthritis & Cartilage; 2008; 17825586⁷³	845	170		63.6(8.8)	(58%)			X					X		Cross- sectional	10
Davies-Tuck M; Osteoarthritis & Cartilage; 2008; 17869546⁷⁴	100	100	0	63.6(10.2)	61(61%)	X			X						Longitudinal Prospective	11
Folkesson J; Academic Radiology; 2007; 17889339⁷⁵	.			56 (Range: 22–79)	(59%)										Other	7
Sanz R; Journal of Magnetic Resonance Imaging; 2008; 18022850⁷⁶	22	9		Normal: 43.6(15); Chondromalacia: 33.3(11.8); OA Pts: 58.9(11.5)	14(64%)		X		X						Case control	6
Englund M; Arthritis & Rheumatism; 2007; 18050201⁷⁷	310	102	208	Cases: 62.9(8.3); Controls: 61.2(8.3)	211(68%)			X					X		Case control	15
Hernandez-Molina G; Arthritis & Rheumatism; 2008; 18163483⁷⁸	258	258	0	66.6(9.2)	(42.6%)			X	X			X		X	Longitudinal Prospective	11
Amin S; Osteoarthritis & Cartilage; 2008; 18203629⁷⁹	265	265		67(9)	(43%)			X	X				X	X	Longitudinal Prospective	11
Teichtahl AJ; Obesity; 2008; 18239654⁸⁰	297		297	58(5.5)	186	X		X	X		X				Longitudinal Prospective	14
Anandacoomarasamy; Journal of Rheumatology; 2008; 18278831⁸¹	32	32		Males: 64(11.5); Females: 66(9.5); Total: 65(Range: 42–87)	17(53%)	X		X	X						Longitudinal Prospective	11
Eckstein F; Annals of the Rheumatic Diseases; 2008; 18283054⁸²	158			Mild to moderate OA2: 57.6(8.3); Controls: 56.1(8.7)	158(100%)	X			X						Case control	10
Reichenbach S; Osteoarthritis & Cartilage; 2008; 18367415⁸³	964	217	747	63.3	(57%)			X	X		X				Cross- sectional	8
Petterson SC; Medicine & Science in Sports & Exercise; 2008; 18379202⁸⁴	123	123	0	64.9(8.5)	67										Case control	11
Bolbos RI; Osteoarthritis & Cartilage; 2008; 18387828⁸⁵	32			Cases: 47.2(11.5), (Range: 29–72); Controls: 36.3(10.5), Range: (27–56)	14(44%)	X	X		X		X				Case control	7
Pai A; Magnetic Resonance Imaging; 2008; 18502073⁸⁶	10	0	10	27 (Range: 21–31)	4(40%)		X		X						Other	6
Folkesson J; Magnetic Resonance in Medicine; 2008; 18506845⁸⁷			143	Healthy subjects: 48(Range: 21–78); KL1: 62(Range: 37–81); KL2: 67(Range: 47–78); KL3&4: 68(58–78)					X						Other	12
Mills PM; Osteoarthritis & Cartilage; 2008; 18515157⁸⁸	49	25	24	APMM: 46.8(5.3); Controls: 43.6(6.6)	18(36.7%)	X		X	X						Case control	12
Dore D; Osteoarthritis & Cartilage; 2008; 18515160⁸⁹	50	50		64.5(7.1)	23	X		X	X		X				Cross- sectional	9
Pelletier JP; Osteoarthritis & Cartilage; 2008; 18672386⁹⁰	27	1		64.1(9.6)	14			X	X	X	X	X	X		Other	9
Englund M; New England Journal of Medicine; 2008; 18784100⁹¹	991	171		62.3(8.6), (Range: 50.1–90.5)	565(57%)			X					X		Cross- sectional	10
Rauscher I; Radiology; 2008; 18936315⁹²	60	37	23	Healthy controls: 34.1(10); Mild OA: 52.5(10.9); Severe OA: 61.6(11.6)	32(53.3%)		X		X				X		Case control	9
Kijowski R.; Radiology; 2009; 19164121⁹³	200		200	1.5T image group: 38.9(Range: 16–63); 3T image group: 39.1(Range: 15–65)	87(43.5%)			X	X						Longitudinal Retropective	10

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Inter- and intra-reader CV and test-retest measures were confined to quantitative or compositional measures (Tables II and III). The pooled CV for quantitative cartilage was 3% for both inter- and intra-reader reliability.

Table II.

Results of random-effects pooling of intra-reader CV from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament)

Stratification	Number of estimates (Studies)	Mean sample size	Pooled CV (%)	95% CI
Quantitative
Cartilage	32 (10)	60	3	−2, 7
Synovium	2 (1)	94	8	−6, 22
Compositional	6 (1)	60	5	−5, 15

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Table III.

Results of random-effects pooling of inter-reader CV from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament)

Stratification	Number of estimates (Studies)	Mean sample size	Pooled CV (%)	95% CI
Quantitative
Cartilage	42 (13)	65	3	−1, 6
Synovium	1 (1)	94	5	−15, 25
Bone	9 (5)	119	2	−4, 8

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The inter-reader and intra-reader ICCs for quantitative and semi-quantitative measures were all excellent (range 0.8–0.94)(Tables IV and V). For quantitative measures the intra-reader ICC ranged from 0.87 (0.61–1.00) for synovium to 0.93 (0.82–1.00) for meniscus measurement. For quantitative measures the inter-reader ICC ranged from 0.81 (0.72–0.89) for meniscus to 0.90 (0.86–0.95) for cartilage morphometry measurement.

Table IV.

Results of random-effects pooling of intra-reader ICC from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament)

Stratification	Number of estimates (Studies)	Mean sample size	Pooled ICC	95% CI
Quantitative
Cartilage	23 (9)	108	0.92	0.88, 0.96
Synovium	2 (1)	30	0.87	0.61, 1.00
Meniscus	1 (1)	291	0.93	0.82, 1.00
Semi-quantitative
Cartilage	7 (4)	114	0.94	0.87, 1.00
Synovium	3 (2)	26	0.88	0.66, 1.00
Bone Marrow Lesion	2 (2)	178	0.93	0.83, 1.00
Meniscus	2 (1)	25	0.77	0.49, 1.00

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Table V.

Results of random-effects pooling of inter-reader ICC from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament)

Stratification	Number of estimates (Studies)	Mean sample size	Pooled ICC	95% CI
Quantitative
Cartilage	10 (4)	196	0.90	0.86, 0.95
Meniscus	2 (1)	291	0.81	0.72, 0.89
Semi-Quantitative
Cartilage	9 (7)	88	0.85	0.77, 0.94
Synovium	5 (4)	46	0.87	0.74, 1.00
Bone	3 (2)	23	0.90	0.66, 1.00
Bone Marrow Lesion	2 (2)	22	0.84	0.54, 1.00
Meniscus	5 (3)	67	0.93	0.82, 1.00
Ligament	4 (2)	105	0.80	0.56, 1.00

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The inter-reader and intra-reader kappa values for quantitative and semi-quantitative measures were all moderate to excellent (range 0.52–0.88)(Tables VI and VII). For semi-quantitative measures the range for intra-reader kappa values extended from 0.52 (0.28–0.77) for synovium to 0.66 (0.54–0.78) for BML assessment. For semi-quantitative measures the range for inter-reader kappa values extended from 0.57 (0.44–0.71) for cartilage morphology to 0.88 (0.79–0.97) for BML assessment.

Table VI.

Results of random-effects pooling of intra-reader kappa values from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament)

Stratification	Number of estimates (Studies)	Mean sample size	Pooled Kappa	95% CI
Quantitative
Cartilage	1 (1)	158	0.66	0.50, 0.82
Semi-Quantitative
Synovium	4 (2)	317	0.52	0.28, 0.77
Bone Marrow Lesion	1 (1)	256	0.66	0.54, 0.78

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Table VII.

Results of random-effects pooling of inter-reader kappa values from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament)

Stratification	Number of estimates (Studies)	Mean sample size	Pooled Kappa	95% CI
Semi-quantitative
Cartilage	15 (4)	136	0.57	0.44, 0.71
Bone marrow lesion	2 (2)	237	0.88	0.79, 0.97
Meniscus	3 (3)	418	0.73	0.63, 0.84
Ligament	3 (3)	209	0.80	0.69, 0.90

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Responsiveness

The responsiveness analysis included data from 42 manuscripts (Table VIII). The mean Downs criteria score for these manuscripts was 11.2 (range 8–21). Table IX includes the summary responsiveness data for both types of measurement methods (quantitative and semi-quantitative). As some studies reported multiple estimates, random-effects model pooling was done to reduce potential bias from studies reporting multiple estimates. The pooled SRM for quantitative measures of cartilage morphometry for the medial tibiofemoral joint was −0.86 (95%CI −1.26 to −0.46), for lateral tibofemoral joint was −1.01 (95%CI −2.04 to 0.02), and for the patella was −0.63 (95%CI −0.90 to −0.37). The quantitative cartilage morphometry pooled SRM ranged from −0.21 (−0.48 to 0.05) for the lateral femoral plate to −1.01 (−2.04 to 0.02) for lateral tibiofemoral plate. The results for the compositional measures are from one study and should be interpreted with caution. The pooled SRM for semi-quantitative measures of cartilage for medial tibiofemoral joint was 0.55 (95%CI 0.47–0.64), for lateral tibofemoral joint was 0.37 (95%CI 0.18–0.57), and for the patella was 0.29 (95% CI 0.03–0.56). The semi-quantitative cartilage morphology SRMs ranged from −0.07 (−0.18 to 0.04) for the medial tibial region to 0.55 (0.47–0.64 for the medial tibiofemoral region. The pooled SRM for semi-quantitative measures of synovium was 0.47 (95%CI 0.18–0.77), and for BMLs was 0.43 (95%CI −0.17 to 1.03).

Table VIII.

Summary table of studies reporting data on responsiveness of MRI in OA

Reference: Author, Journal, Year, PMID	Whole sample size	No. of cases	No. of controls	Age, yrs, Mean(SD), Range	No. (%) of females	Quantitative	Compositional technique	Semi- quantitative	Cartilage	Synovium	Bone	Bone marrow lesions	Meniscus	Study design	Downs criteria score
Wluka AE; Arthritis & Rheumatism; 2002; 12209510³⁰	123	123	0	63.1(10.6)	71	X			X		X			Longitudinal Prospective	14
Cicuttini FM; Journal of Rheumatology; 2002; 12233892⁹⁴	21	8	13	Case:41. 3(13.2); Controls: 49.2(17.8)	14(66.7%)	X			X					Longitudinal Prospective	13
Biswal S; Arthritis & Rheumatism; 2002; 12428228⁷	43	4	39	54.4(Range 17–65)	21			X	X					Longitudinal Prospective	8
Gandy SJ; Osteoarthritis & Cartilage; 2002; 12464553³¹	16	16	0	63.4 (Range 52–70)	6	X			X					Longitudinal Prospective	8
Wluka AE; Journal of Rheumatology; 2002; 12465157⁹⁵	136	136	0	Vitamin E group: 64.3(11); Placebo group: 63.7(10)	75(55%)	X			X					Randomized controlled trial	21
Cicuttini F; Journal of Rheumatology; 2002; 12465162⁹⁶	110	110	0	63.2(10.2)	66	X			X					Longitudinal Prospective	12
Pessis E; Osteoarthritis & Cartilage; 2003; 12744942⁹⁷	20	20		63.9(9)	13	X		X	X					Longitudinal Prospective	12
Cicuttini FM; Arthritis & Rheumatism; 2004; 14730604³⁹	117	117		63.7(10.2)	(58.1%)	X			X					Longitudinal Prospective	9
Raynauld JP; Arthritis & Rheumatism; 2004; 14872490⁴⁰	32	32	0	62.9(8.2)	(74%)	X			X					Longitudinal Prospective	10
Wluka AE; Annals of the Rheumatic Diseases; 2004; 14962960⁹⁸	132	132	0	63.1(Range: 41–86)	71(54%)	X			X					Longitudinal Prospective	10
Cicuttini FM; Journal of Rheumatology; 2004; 15229959⁴³	102	102	0	63.8(10.1)	(63%)	X			X					Longitudinal Prospective	10
Blumenkrantz G; Osteoarthritis & Cartilage; 2004; 15564067⁹⁹	38	30	8	58(Range: 28–81)	(39.5%)	X	X		X					Longitudinal Prospective	9
Zhai G; BMC Musculoskeletal Disorders; 2005; 15720725¹⁰⁰	150	80	70	TASOAC dataset: 62.3(7.6); KCV dataset: 42.8(6.1)	79(52.7%)	X			X					Other	9
Wang Y; Arthritis Res Ther; 2005; 15899054¹⁰¹	126	126		63.6(10.1)	68						X			Longitudinal Prospective	12
Cicuttini F; Osteoarthritis & Cartilage; 2005; 15922634⁴⁹	28	28	0	62.8(9.8)	(57%)	X			X					Longitudinal Prospective	10
Wluka AE; Rheumatology; 2005; 16030084⁵¹	126	126	0	63.6(10.1)	68(54%)	X			X					Longitudinal Prospective	14
Ding C; Arthritis & Rheumatism; 2005; 16320339¹⁰²	325			45.2(6.5)	190	X		X	X					Longitudinal Prospective	10
Raynauld JP; Arthritis Research & Therapy; 2006; 16507119⁵⁵	110	110	0	62.4(7.5)	(64%)	X			X					Longitudinal Prospective	11
Hunter DJ; Arthritis & Rheumatism; 2006; 16508930⁵⁶	257	257	0	66.6(Range: 47–93)	(41.6%)			X	X					Longitudinal Prospective	10
Hunter, DJ; Osteoarthritis & Cartilage; 2006; 16678452¹⁰³	150	150	0	58.9(Range: 44–81)	(72%)	X		X	X	X	X	X		Longitudinal Prospective	9
Wluka AE; Arthritis Research & Therapy; 2006; 16704746¹⁰⁴	105	105	0	All eligible: 62.5(10.7); MRI at FU: 63.8(10.6); Lost to FU: 61.6(11.3)	61(58.1%)	X			X					Longitudinal Prospective	17
Ding C; Rheumatology; 2007; 16861710¹⁰⁵	325			45.2(6.4)	190	X			X					Longitudinal Prospective	12
Hunter DJ; Arthritis & Rheumatism; 2006; 16868968¹⁰⁶	264	264	0	66.7(9.2), (Range: 47–93)	(40.9%)			X	X				X	Longitudinal Prospective	9
Bruyere O; Osteoarthritis Cartilage; 2007; 16890461¹⁰⁷	62			64.9 (10.3)	(74%)	X			X					Longitudinal Prospective	10
Stahl R; Osteoarthritis & Cartilage; 2007; 17561417¹⁰⁸	18	8	10	OA Pts: 55.7(7.3); Controls: 57.6(6.2)	18(100%)		X		X					Case control	10
Pelletier JP; Arthritis Research & Therapy; 2007; 17672891¹⁰⁹	110	110		Q1greatestlossglobal: 63.7(7.2); Q4 least loss global: 61.3(7.5); Q1 greatest loss_med: 64.1(7.4); Q1 least loss_medial: 61.6(7.8)	74(67.3%)	X			X					Longitudinal Prospective	15
Raynauld JP; Annals of the Rheumatic Diseases; 2008; 17728333⁷¹	107	107	0	62.4(7.5)	(64%)	X			X			X		Longitudinal Retrospective	15
Davies-Tuck M; Osteoarthritis & Cartilage; 2008; 17869546⁷⁴	100	100	0	63.3(10.2)	61(61%)	X			X					Longitudinal Prospective	11
Hunter DJ; Arthritis Research & Therapy; 2007; 17958892¹¹⁰	160	80	80	67(9)	(46%)			X	X					Case control	11
Teichtahl AJ; Osteoarthritis & Cartilage; 2008; 18194873¹¹¹	99	99	0	63(10)	(60%)	X			X					Longitudinal Prospective	14
Hunter DJ; Annals of the Rheumatic Diseases; 2009; 18408248¹¹²	150	150		60.9(9.9)	76(51%)	X			X					Longitudinal Prospective	8
Folkesson J; Magnetic Resonance in Medicine; 2008; 18506845⁸⁷	288		143	KL0(Healthy): 48(Range: 21–78); KL1: 62(Range: 37–81); KL2: 67(Range: 47–78); KL3&4: 68(Range: 58–78)	(44%)				X					Other	12
Sharma L; Arthritis & Rheumatism; 2008; 18512777¹¹³	153	153	0	66.4(11)		X			X					Longitudinal Prospective	11
Teichtahl AJ; Osteoarthritis & Cartilage; 2009; 18590972¹¹⁴	78			63 (10.5)	(52%)	X			X					Longitudinal Prospective	14
Raynauld JP; Annals Rheumatic Disease; 2009; 18653484¹¹⁵	154			60.3 (8.1)	100 (65%)	X			X					Randomized controlled trial	11
Pelletier JP; Osteoarthritis & Cartilage; 2008; 18672386⁹⁰	27	1		64.1(9.6)	14	X		X	X	X		X		Other	9
Wirth W; Osteoarthritis & Cartilage; 2009; 18789729¹¹⁶	79			60.3 (9.5)	79 (100%)	X			X					Longitudinal Prospective	14
Eckstein F; Arthritis & Rheumatism; 2008; 18975356¹¹⁷	174	174	0	66(11.1)	(76%)	X			X					Longitudinal Prospective	8
Hellio Le Graverand MP; Annals Rheumatic Diseases; 2008; 19103634¹¹⁸	180				(100%)	X			X					Longitudinal Prospective	19
Eckstein F; Arthritis Research Therapy; 2009; 19534783¹¹⁹	79			60.3 (9.5)	79 (100%)	X			X					Longitudinal Prospective	15
Eckstein F; Arthritis Rheum; 2009: 19714595¹²⁰	80			60.9 (9.1)	48 (60%)	X			X					Longitudinal Prospective	14
Hunter DJ; Osteoarthritis & Cartilage; 2009; 19744588¹²¹	150	150		60.9(9.9)	76(51%)	X			X					Longitudinal Prospective	18

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Table IX.

Results of random-effects pooling of SRM from MRI studies stratified by measure (quantitative and semi-quantitative) and tissue (cartilage, synovium, bone, bone marrow lesion, meniscus, and ligament). Studies with multiple estimates had an estimate selected at random and a pooled analysis was performed. The process was repeated 500 times to obtain the empirical distribution of pooled SRMs

Stratification	Number of estimates (Studies)	Mean sample size	Pooled SRM	95% CI
Quantitative cartilage^*
Medial femoral	54 (12)	118	−0.51	−0.74, −0.28
Medial tibial	55 (17)	134	−0.48	−0.63, −0.34
Medial tibiofemoral	31 (12)	92	−0.86	−1.26, −0.46
Lateral femoral	32 (8)	151	−0.21	−0.48, 0.05
Lateral tibial	44 (14)	152	−0.56	−0.72, −0.39
Lateral tibiofemoral	14 (5)	110	−1.01	−2.04, 0.02
Patella	13 (9)	131	−0.63	−0.90, −0.37
Global	5 (4)	48	−0.89	−2.59, 0.80
Quantitative other^*
Denuded area	19 (2)	114	−0.20	−0.85, 0.45
Bone	14 (2)	167	0.12	−0.46, 0.70
Bone marrow lesion	4 (1)	107	0.11	−0.08, 0.30
Meniscus	2 (1)	264	−0.24	−0.36, −0.12
Compositional	3 (1)	18	−3.27	−3.73, −2.81
Semi-quantitative cartilage^†
Medial tibial	1 (1)	325	−0.07	−0.18, 0.04
Medial tibiofemoral	3 (3)	224	0.55	0.47, 0.64
Lateral tibial	1 (1)	325	−0.05	−0.15, 0.06
Lateral tibiofemoral	3 (3)	224	0.37	0.18, 0.57
Patella	2 (2)	238	0.29	0.03, 0.56
Semi-quantitative other^*
Synovium	3 (2)	68	0.47	0.18, 0.77
Osteophytes	4 (1)	150	0.36	0.20, 0.52
Bone marrow lesion	6 (2)	130	0.43	−0.17, 1.03
Meniscus	2 (1)	264	0.27	0.15, 0.39

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Analysis used re-sampling techniques.

^†

Analysis did not use re-sampling techniques.

There has been some concern that some of the earlier literature for quantitative measures of cartilage morphometry was more responsive than more recent estimates. Table X reflects an effort to distil distinct time periods. In general, the earlier estimates demonstrate larger SRMs than more recent studies with the medial tibiofemoral estimates from 2002–2006 being −0.95 (−1.15, −0.76) and from more recent studies (2007–2009) being −0.84 (−1.35, −0.33).

Table X.

Results of random-effects pooling of SRM from MRI studies evaluating quantitative cartilage stratified by year of publication and plate region. Studies with multiple estimates had an estimate selected at random and a pooled analysis was performed. The process was repeated 500 times to obtain the empirical distribution of pooled SRMs

Stratification	Number of estimates (Studies)	Mean sample size	Pooled SRM	95% CI
2002–2006
Medial femoral	3 (3)	126	−0.59	−1.21, 0.03
Medial tibial	7 (7)	123	−0.58	−0.81, −0.35
Medial tibiofemoral^*	4 (3)	51	−0.95	−1.15, −0.76
Lateral femoral	1 (1)	117	−0.01	−0.19, 0.17
Lateral tibial	6 (6)	139	−0.55	−0.82, −0.29
Patella	5 (5)	141	−0.68	−1.04, −0.32
Global	2 (2)	24	−0.58	−1.15, −0.02
2007–2009
Medial femoral	51 (9)	117	−0.49	−0.75, −0.22
Medial tibial	48 (10)	135	−0.42	−0.62, −0.22
Medial tibiofemoral	27 (9)	98	−0.84	−1.35, −0.33
Lateral femoral	31 (7)	152	−0.24	−0.53, 0.05
Lateral tibial	38 (8)	154	−0.56	−0.79, −0.33
Lateral tibiofemoral	14 (5)	110	−1.01	−2.04, 0.02
Patella	8 (4)	125	−0.58	−0.97, −0.18
Global	3 (2)	63	−1.24	−4.42, 1.94

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Note: All analyses of articles published in 2002–2006 did not use re-sampling techniques except for the medial tibial-femoral component. All analyses of articles published in 2007–2009 did use re-sampling techniques.

Table XI shows the results of random-effects pooling of SRM from MRI studies evaluating quantitative cartilage stratified by duration of study and plate region for studies published between 2007 and 2009. Studies with multiple estimates had an estimate selected at random and a pooled analysis was performed. In this analysis the pooled SRM for the medial tibiofemoral joint for studies of 1 year or less is −0.80 (−1.27, −0.33) and for studies of 1–2 years is −1.16 (−2.90, 0.58).

Table XI.

Results of random-effects pooling of SRM from MRI studies evaluating quantitative cartilage stratified by duration of study and plate region for studies published between 2007 and 2009. Studies with multiple estimates had an estimate selected at random and a pooled analysis was performed. The process was repeated 500 times to obtain the empirical distribution of pooled SRMs

Stratification	Number of estimates (Studies)	Mean sample size	Pooled SRM	95% CI
Quantitative cartilage
1 year or less
Medial femoral	27 (5)	82	−0.49	−0.81, −0.17
Medial tibial	18 (6)	93	−0.33	−0.53, −0.13
Medial tibiofemoral	16 (6)	83	−0.80	−1.27, −0.33
Lateral femoral	7 (3)	137	−0.30	−0.98, 0.38
Lateral tibial	8 (4)	130	−0.56	−0.88, −0.24
Lateral tibiofemoral	3 (2)	79	−1.03	−2.79, 0.73
Patella	7 (3)	129	−0.47	−0.92, −0.02
Global	2 (1)	18	0.45	−0.01, 0.92
1–2 years
Medial femoral	6 (3)	104	−0.51	−1.15, 0.13
Medial tibial	6 (3)	104	−0.63	−1.14, −0.12
Medial tibiofemoral	5 (2)	53	−1.16	−2.90, 0.58
Lateral femoral	6 (3)	104	−0.21	−0.51, 0.09
Lateral tibial	6 (3)	104	−0.61	−1.14, −0.08
Lateral tibiofemoral	5 (2)	53	−1.28	−3.48, 0.91
Patella	1 (1)	99	−0.90	−1.10, −0.71
Global	1 (1)	154	−2.85	−3.01, −2.70
Greater than 2 years^*
Medial femoral	18 (1)	174	−0.32	−0.47, −0.17
Medial tibial	24 (1)	174	−0.27	−0.42, −0.12
Medial tibiofemoral	6 (1)	174	−0.41	−0.56, −0.26
Lateral femoral	18 (1)	174	−0.22	−0.37, −0.07
Lateral tibial	24 (1)	174	−0.42	−0.57, −0.27
Lateral tibiofemoral	6 (1)	174	−0.43	−0.57, −0.28

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Represents results of one study¹¹⁷.

Discussion

The purpose of this study was to summarize the literature on the responsiveness and reliability of MRI-based measures of knee OA structural change. In general, this review provides clear evidence that structural change in OA can be measured both reliably and with good responsiveness on MRI.

The data from this review indicates that quantitative measures of joint structure have excellent reliability (ICC range 0.81–0.94). Similarly agreement for semi-quantitative measures is good to excellent (kappa range 0.52–0.88). Directly comparing the reliability between quantitative and semi-quantitative techniques is not possible given the extracted data comes from different studies and the statistical methods used are frequently distinct but an overarching view would suggest they are broadly comparable with a slight benefit in reliability for quantitative measures. This is not surprising given the continuous nature of these measures, the greater use of technology to automate processes and quality control vigilance in quantitative measures.

The aim of the systematic review is to provide a summary of the best evidence. However, as a result of issues related to the quality of research, findings of studies can sometimes be misleading or incorrect. To minimize these risks, the quality of the studies was critically appraised using Downs checklist³. The findings from our review indicate that in general this literature is of adequate quality. No studies were identified in our search prior to 1994.

Several studies have suggested that baseline clinical, biomarker and imaging features are predictive of progression of cartilage loss in the medial compartment of the knee and could be used to provide greater study power by selecting a population at greater risk for more rapid progression. Whilst the estimates included in this analysis reflect these studies we have not explicitly selected for these studies so the pooled estimates reflect all studies not just selected estimates for those at highest risk for progression.

This review does not include results focused upon using MRI to stage OA. Whilst MRI has been extensively used for measuring progression its use in staging OA as a disease is at this point quite limited. In an effort to shorten discovery and development timelines, clinical trial brevity is paramount. As OA is typically a very slowly progressive condition, one can optimize trial efficiency by finding more responsive endpoint/s. The results of the responsiveness data reaffirm the potential benefit of MRI compared to plain radiography that generally has SRMs in the 0.3–0.4 range¹². For MRI there is quite a lot of variability between different regions within the knee, and with different measures of different tissues, yet the SRM of −0.86 (95%CI −1.26 to −0.46) for the medial tibiofemoral joint quantitative cartilage measure provides advantages with regards to adequately powering studies.

Interestingly there have been a number of concerns raised about what appears to be conflicting data from earlier studies that were more responsive than studies conducted more recently. This analysis confirms that more recent studies (2007–2009) have slightly more conservative SRMs than earlier studies (2002–2006). For example the SRM for the medial tibiofemoral joint quantitative cartilage measure is −0.95 (−1.15, −0.76) for studies from 2002–2006 and is −0.84 (−1.35, −0.33) for studies from 2007 to 2009. The CIs for both these periods overlap and while there may be some differences in techniques between the two time periods including routine blinding to sequence in more recent studies that may explain differences, identifying the reasons for these differences was not the focus of this analysis. We have also been able to clearly demonstrate that adequate responsiveness can be attained in periods as short as 12 months.

Semi-quantitative scoring of MRIs is a valuable method for performing multi-feature assessment of the knee using conventional MRI acquisitions^6–8,98. The responsiveness of the semi-quantitative assessment of medial tibiofemoral cartilage morphology (SRM 0.55) is broadly consistent with quantitative assessment for the medial tibiofemoral joint. Semi-quantitative assessment of synovium also demonstrated good responsiveness (SRM 0.52). In addition the semi-quantitative assessment of BMLs, a structural target with good clinical and predictive validity was also adequately responsive (SRM 0.43).

In summary, OA changes on MRI can be measured reliably using both quantitative and semi-quantitative techniques. MRI can accurately and feasibly measure change in quantitative cartilage morphometry over 12 months for knee OA. Based upon extant literature these study findings strongly support inclusion of MRI structure in updated regulatory guidance statements for clinical trials of structure modifying agents in OA.

Acknowledgements

We recognize the invaluable support of Valorie Thompson for administrative and editorial support and OARSI for their invaluable support of this activity. This analysis and literature review was undertaken to facilitate discussions and development of recommendations by the Assessment of Structural Change Working group for the OARSI FDA Initiative. The members of the working group were: Philip Conaghan, MB, BS, PhD (Chair), David Hunter, MBBS, PhD, Jeffrey Duryea, PhD, Garry Gold, MD, Steven Mazzuca, PhD, Jean Francis Maillefert, MD, Timothy Mosher, MD, Hollis Potter, MD, David Felson, MD, Ali Guermazi, MD, Helen Keen, MD, Gayle Lester, PhD, Wayne Tsuji, MD, John Randle, PhD, Felix Eckstein, MD, Erika Schneider, PhD, Elena Losina, PhD, Sarah Kingsbury, PhD, William Reichman, PhD, Jean Pierre Pelletier, MD, Saara Totterman, MD, PhD, Rose Maciewicz, PhD, Bernard Dardzinski, PhD, Mona Wahba, MD, Marie Pierre Hellio Le Graverand-Gastineau, MD, PhD, DSc, Elisabeth Morris, DVM, Jeffrey Kraines, MD, Lucio Rovati, MD, Don Dreher, MD, PhD, James Huckle, PhD, Mary-Ann Preston, PhD, Brooks Story, PhD.

Declaration of funding and role of funding source

The OARSI FDA OA Initiative received financial support from the following professional organization:

American College of Rheumatology

Additionally the OARSI FDA OA Initiative received financial support from the following companies:

Amgen
ArthroLab
AstraZeneca
Bayer Healthcare
Chondrometrics
CombinatoRx
Cypress BioScience
DePuy Mitek
Expanscience 4QImaging
Genevrier/IBSA
Genzyme
King (Alpharma)
Merck
Merck Serono
NicOx
Pfizer
Rottapharm
Smith & Nephew
Wyeth

While individuals from pharmaceutical, biotechnology and device companies actively participated in on-going working group discussions, due to the conflict of interest policy enacted by OARSI, these individuals were not allowed to vote on the final recommendations made by OARSI to the Food and Drug Administration.

Footnotes

Author contributions

DJH conceived and designed the study, drafted the manuscript and takes responsibility for the integrity of the work as a whole, from inception to finished article. EL and WZ were also involved in the design of the study. All authors contributed to acquisition of the data. All authors critically revised the manuscript and gave final approval of the article for submission.

The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Conflict of interest

David Hunter receives research or institutional support from DonJoy, NIH, and Stryker.

Other authors declared no conflict of interest.

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PERMALINK

Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence

DJ Hunter

W Zhang

PG Conaghan

K Hirko

L Menashe

WM Reichmann

E Losina

SUMMARY

Objective

Methods

Results

Conclusion

Introduction

Material and methods

Systematic literature search details

Inclusion/exclusion criteria

Fig. 1.

Data abstraction

Statistical analysis

Results

Reliability

Table I.

Table II.

Table III.

Table IV.

Table V.

Table VI.

Table VII.

Responsiveness

Table VIII.

Table IX.

Table X.

Table XI.

Discussion

Acknowledgements

Footnotes

References

ACTIONS

PERMALINK

RESOURCES

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