Review Article

A Hierarchy of Patient-Reported Outcomes for Meta-Analysis of Knee Osteoarthritis Trials: Empirical Evidence from a Survey of High Impact Journals

Table 1

Characteristics of included studies.

AuthorJournalComparisonNumber of randomised patientsConstructSelective
outcome reporting
OutcomeNumber of patientsStandard mean differences (SMD) measured as Cohens’ d (SE)Rank of responsiveness measured as SMD

Altman et al. (Flexx)
2009
Semin Arthritis Rheum.Sodium hyaluronate versus saline588PainUnclearWOMAC291/2950.143 (0.083)2
VAS (walking)285/2950.259 (0.083)1
WOMAC291/2950.194 (0.083)1
DisabilitySF-36 (PCS)291/2950.191 (0.083)2
SF-36 (PF)291/2950.170 (0.083)3
Baltzer et al.
2009
Osteoarthritis and CartilageAutologous conditioned serum (ACS) versus saline241PainUnclearWOMAC134/1070.703 (0.166)2
VAS (activity)134/1070.937 (0.169)1
DisabilityWOMAC134/1070.699 (0.166)1
SF-8 (PCS)134/1070.682 (0.166)2
Hyaluronan versus saline242PainUnclearWOMAC135/1070.050 (0.162)1
VAS (activity)135/1070.035 (0.162)2
DisabilityWOMAC135/1070.078 (0.162)2
SF-8 (PCS)135/1070.146 (0.162)1
Barthel et al.
2009
Semin Arthritis  Rheum.Diclofenac versus vehicle492PainUnclearWOMAC254/2380.234 (0.091)2
VAS (activity)254/2380.281 (0.091)1
Bennell et al.
2005
Ann. Rheum. Dis.Multimodal physiotherapy programme versus placebo140PainUnclearWOMAC73/670.122 (0.169)3
VAS (activity)73/670.223 (0.170)1
SF-36 (BP)73/670.071 (0.169)4
VAS (knee)73/670.216 (0.170)2
DisabilityWOMAC73/670.085 (0.169)2
SF-36 (PF)73/670.236 (0.170)1
Berman et al.
2004
Ann. Intern. Med.Acupuncture versus sham  acupuncture381DisabilityUnclearWOMAC142/1410.201 (0.146)1
SF-36 (PCS)142/1410.134 (0.146)2
Education versus sham acupuncture380DisabilityUnclearWOMAC141/108 −0.244 (0.154)2
SF-36 (PCS)141/108−0.255 (0.154)1
Burch et al.
2008
Osteoarthritis and CartilagePattern stimulation versus control (TENS)116PainUnclearWOMAC52/530.698 (0.201)1
VAS (global)52/530.231 (0.195)2
Case et al.
2003
Ann. Intern. Med.Diclofena versus placebo53PainUnclearWOMAC25/280.446 (0.338)1
Lequesne25/280.190 (0.334)2
Acetaminophen versus placebo57PainUnclearWOMAC29/280.096 (0.326)2
Lequesne29/280.217 (0.326)1
Clegg et al.
2006
N. Engl. J. Med.Glucosamine + chondroitin versus placebo630PainInadequateWOMAC317/3130.127 (0.126)2
HAQ317/3130.146 (0.126)1
DisabilityWOMAC317/3130.137 (0.126)1
HAQ317/3130.104 (0.126)2
Glucosamine versus placebo630PainInadequateWOMAC317/313−0.028 (0.126)1
HAQ317/313−0.021 (0.126)2
DisabilityWOMAC317/313−0.013 (0.126)2
HAQ317/3130.056 (0.126)1
Chondroitin versus placebo631PainInadequateWOMAC318/313−0.020 (0.126)2
HAQ318/313−0.046 (0.126)1
DisabilityWOMAC318/3130.023 (0.126)2
HAQ318/3130.029 (0.126)1
Celecoxib versus placebo631PainInadequateWOMAC318/3130.132 (0.126)1
HAQ318/3130.130 (0.126)2
DisabilityWOMAC318/3130.179 (0.126)1
HAQ318/3130.114 (0.126)2
Forestier et al.
2009
Ann. Rheum. Dis.Spa therapy versus control451PainAdequateVAS (knee)193/1860.310 (0.103)1
SF-36 (BP)194/1850.190 (0.103)2
DisabilityWOMAC179/1720.366 (0.108)1
SF-36 (PCS)190/1770.153 (0.105)2
SF-36 (PF)195/1860.070 (0.103)3
Geba et al.
2002
JAMARofecoxib 25 mg/d versus acetaminophen189PainInadequateVAS (walking)95/940.467 (0.208)1
VAS (night)95/940.394 (0.207)3
VAS (rest)95/940.411 (0.206)2
Rofecixib 12.5 mg/d versus acetaminophen190PainInadequateVAS (walking)96/940.191 (0.206)1
VAS (night)96/940.069 (0.206)3
VAS (rest)96/940.135 (0.206)2
Celecoxib versus  Acetaminophen191PainInadequateVAS (walking)97/940.233 (0.206)1
VAS (night)97/94−0.043 (0.206)3
VAS (rest)97/940.074 (0.206)2
Gibofsky et al.
2003
Arthritis, Rheum.Rofecoxib versus placebo285PainUnclearWOMAC189/960.489 (0.163)1
VAS (walking)189/960.366 (0.162)2
Celecoxib versus placebo286PainUnclearWOMAC190/960.514 (0.163)1
VAS (walking)190/960.451 (0.163)2
Hinman et al.
2003
BMJTappening versus placebo58PainUnclearWOMAC29/290.160 (0.318)4
NRS (activity)29/290.802 (0.329)1
NRS (walking)29/290.795 (0.329)2
SF-36 (BP)29/290.308 (0.320)3
DisabilityWOMAC29/291.019 (0.340)1
SF-36 (PF)29/290.247 (0.323)2
Control tape versus placebo58PainUnclearWOMAC29/290.649 (0.329)1
NRS (activity)29/290.376 (0.329)4
NRS (walking)29/290.649 (0.329)1
SF-36 (BP)29/290.431 (0.325)3
DisabilityWOMAC29/290.640 (0.329)1
SF-36 (PF)29/290.230 (0.323)2
Hughes and Carr
2002
RheumatologyGlucosamine sulphate versus placebo80PainUnclearWOMAC39/39−0.066 (0.227)3
VAS (activity)39/39−0.020 (0.226)5
VAS (knee)39/39−0.032 (0.226)4
VAS (rest)39/390.323 (0.228)1
McGill (sense)39/390.221 (0.227)2
Kirkley et al.
2008
N. Engl. J. Med.Arthroscopic surgery versus placebo188PainAdequateWOMAC88/800.316 (0.155)1
ASES88/80−0.073 (0.155)2
DisabilityWOMAC88/800.259 (0.155)1
ASES88/800.209 (0.155)2
SF-36 (PCS)88/80−0.009 (0.155)3
Kitay et al.
2009
Osteoarthritis and CartilageVibrations, CPM, and heat versus sham device71PainAdequateWOMAC24/320.984 (0.284)1
VAS (knee)24/320.984 (0.284)1
Mazières et al.
2007
Ann. Rheum. Dis.Chondroitin sulphate versus placebo307PainUnclearVAS (activity)139/1400.260 (0.120)1
VAS (rest)139/1400.092 (0.120)2
McCarthy et al.
2004
RheumatologyClass-based versus home-based exercise214PainUnclearWOMAC111/1030.321 (0.138)2
VAS (walking)111/1030.836 (0.143)1
Moseley et al.
2002
N. Engl. J. Med.Arthroscopic debridement versus placebo119PainUnclearKnee specific
Pain scale53/550.010 (0.232)3
AIMS (pain)53/55−0.072 (0.224)2
SF-36 (BP)52/550.114 (0.194)1
Arthroscopic lavage versus placebo121PainUnclearKnee specific
Pain scale55/550.110 (0.236)2
AIMS (pain)56/55−0.200 (0.223)1
SF-36 (BP)57/550.090 (0.189)3
Neustadt et al.
2005
J. Rheumatol.Hyalerone four times a week versus control251PainUnclearWOMAC115/1140.098 (0.162)2
VAS (activity)104/1000.158 (0.172)1
Hyalerone three times a week versus control242PainUnclearWOMAC107/114−0.028 (0.164)2
VAS (activity)90/1000.030 (0.176)1
Niethard et al.
2005
J. Rheumatol.Diclofena versus placebo238PainUnclearWOMAC117/1200.363 (0.131)1
VAS (activity)117/1190.360 (0.131)2
Nuñez et al.
2006
Osteoarthritis and CartilageEducation programme versus control100PainUnclearWOMAC43/370.980 (0.237)1
SF-36 (BP)43/370.605 (0.229)2
DisabilityWOMAC43/370.742 (0.232)1
SF-36 (PF)43/370.576 (0.229)2
J. Petrella and M. Petrella
2006
Arch. Intern. Med.Massage versus control74PainAdequateWOMAC34/340.948 (0.256)1
VAS (knee)34/340.872 (0.254)2
Petrella et al.
2006
J. Rheumatol.Hyaleron versuscontrol106PainInadequateWOMAC53/530.092 (0.194)1
VAS (activity)53/53−0.040 (0.194)2
VAS (walking)53/530.000 (0.194)3
DisabilityUnclearWOMAC53/53−0.147 (0.195)2
SF-36 (PF)53/530.084 (0.194)1
Petrella
2002
Arch. Intern. Med.Hyalerone + placebo versus control53PainUnclearWOMAC25/280.190 (0.384)4
VAS (activity)25/280.890 (0.398)1
VAS (rest)25/28−0.539 (0.389)3
VAS (walking)25/280.623 (0.391)2
Hyalerone + NSAID versuscontrol57PainUnclearWOMAC29/280.238 (0.377)4
VAS (activity)29/280.501 (0.381)2
VAS (rest)29/280.383 (0.379)3
NSAID + saline versus control54PainUnclearVAS (walking)29/281.268 (0.403)1
WOMAC26/280.336 (0.384)3
VAS (activity)26/281.622 (0.428)1
VAS (rest)26/280.173 (0.382)4
VAS (walking)26/281.154 (0.406)2
Pham et al.
2004
Ann. Rheum. Dis.Hyalerone versus control206PainUnclearVAS (knee)131/85−0.035 (0.177)2
Painful days131/85−0.078 (0.177)1
Diacerein versus control170PainUnclearVAS (knee)85/85−0.023 (0.188)2
Painful days85/85−0.027 (0.188)1
Ravaud et al.
2009
BMJStandardised consultation versus usual care327DisabilityUnclearWOMAC146/1810.260 (0.112)2
SF-12 (PCS)129/1470.361 (0.122)1
Raynauld et al.
2003
Arthritis Rheum.Triamcinolone versus saline (control)68PainUnclearWOMAC33/330.307 (0.248)2
VAS (knee)33/330.672 (0.253)1
Raynauld et al.
2002
Osteoarthritis and CartilageHylan G-F 20 versus Control255DisabilityUnclearWOMAC124/1070.668 (0.136)1
SF-36 (PCS)124/1070.553 (0.134)2
Rodrigues et al.
2008
Arthritis Rheum.Medial-wedge insole versus neutral insole30PainAdequateVAS (activity)16/141.337 (0.405)1
VAS (rest)16/140.899 (0.384)2
VAS (night)16/140.802 (0.380)3
Rooks et al.
2006
Arthritis RheumPreoperative exercise versus control45PainUnclearWOMAC14/150.220 (0.373)2
SF-36 (BP)14/15−0.322 (0.374)1
DisabilityWOMAC14/150.034 (0.372)2
SF-36 (PF)14/15−0.391 (0.375)1
Sengupta et al.
2008
Arthritis Res. Ther.5-Loxin 250 mg versus control50PainUnclearWOMAC23/231.292 (0.393)2
VAS (knee)23/232.463 (0.467)1
5-Loxin 100 mg versus control50PainUnclearWOMAC24/231.039 (0.379)1
VAS (knee)24/231.918 (0.425)2
Song et al.
2009
Ann. Rheum. Dis.Icatibant 2000 μg versus control29PainUnclearVAS (activity)14/150.492 (0.459)1
VAS (rest)14/150.391 (0.456)2
Icatibant 500 μg versus control27PainUnclearVAS (activity)12/150.411 (0.470)1
VAS (rest)12/150.391 (0.470)2
Tannenbaum et al.
2004
Ann. Rheum. Dis.Lumiracoxib 400 mg versus placebo734PainUnclearWOMAC491/2430.211 (0.132)2
VAS (knee)491/2430.307 (0.132)1
Lumiracoxib 200 mg versus placebo730PainUnclearWOMAC487/2430.189 (0.132)2
VAS (knee)487/2430.236 (0.132)1
Celecoxib versus placebo724PainUnclearWOMAC481/2430.184 (0.132)2
VAS (knee)481/2430.217 (0.132)1
Trnavský et al.
2004
J. Rheumatol.Ibuprofen versus placebo50PainUnclearVAS (walking)25/251.739 (0.332)1
VAS (rest)25/250.932 (0.298)2
VAS (knee)25/250.786 (0.294)3
Vas et al.
2004
BMJAcupuncture versus control97PainUnclearWOMAC48/491.109 (0.218)2
VAS (knee)48/491.249 (0.222)1
Wang et al.
2009
Arthritis Rheum.Tai chi versus control40PainAdequateWOMAC20/200.456 (0.320)1
VAS (knee)20/200.015 (0.316)2
40DisabilityAdequateWOMAC20/200.356 (0.319)2
SF-36 (PCS)20/200.820 (0.329)1
Witt et al.
2005
LancetAcupuncture versus minimal acupuncture226PainUnclearWOMAC149/750.150 (0.142)1
SES149/750.062 (0.142)2
226DisabilityUnclearWOMAC149/750.249 (0.142)1
SF-36 (PCS)149/750.215 (0.142)3
PDI149/750.245 (0.142)2
Wittenberg et al.
2006
Arthritis Rheum.Lumiracoxib versus placebo219PainUnclearWOMAC144/750.406 (0.185)2
VAS (activity)144/750.645 (0.186)1
Celecoxib versus placebo220PainUnclearWOMAC145/750.396 (0.184)2
VAS (activity)145/750.525 (0.185)1

WOMAC (Western Ontario and McMaster Universities Arthritis Index), VAS (visual analogue scale), NRS (numerical rating scale), AIMS (Arthritis Impact Measurement Scale), ASES (Arthritis Self-Efficacy Scale), HAQ (Health Assessment Questionnaire), PDI (Pain Disability Index), SES (Schmerzempfindungsskala) (Pain Experience Scale), SF-36 (Short Form 36), BP (bodily pain), PF (physical function), PCS (Physical Composite Scale).