Evidence Table 17Quality assessment of trials

Internal validity
Author, Year
Country
Randomization adequate?Allocation concealment adequate?Groups similar at baseline?Eligibility criteria specified?Outcome assessors masked?Care provider masked?Patient masked?Intention-to- treat analysisMaintenance of comparable groupsProtocol violation: level acceptable?Acceptable level of attrition?Attrition similar between groups?Quality rating
RRMS - IFN
Schwid, 2007
EVIDENCE trial
YesUnclearYesYesYesNoNoYesUnclearYesUnclearYesFair
Etemadifar, 2007YesUnclearUnclearYesYesNoNoYesUnclearYesYesunclearFair
RRMS - GA
Mikol, 2008
REGARD trial
YesYesYesYesYesNoNoYesUnclearYesYesYesFair
RRMS - Natalizumab
Havrdova, 2009
AFFIRM
YesYesYesYesYesYesYesYesUnclearYesYesYesGood
O’Connor, 2004
RRMS+SPMS
UnclearYesYes - except for time since previous relapseYesYesYesYesYesYesYesYesYesFair-Good - randomization process unclear otherwise good
Investigators, 2008
CAMMS223 trial
YesUnclearYesYesYes for effectivenessNoNoYesYesYesNo - 40% of IFN group discontinued drug and 79% of AL did not receive 3rd doseNo - 40% IFN, 79% ALFair - able to evaluate up to FDA withdrawal date and compare to end of study data
PPMS - Glatiramer acetate
Wolinsky, 2007UnclearUnclearYesYesYesYesUnclearYesYesYesYesYesFair
RRMS+SPMS - NATALIZUMAB
O’Connor, 2004UnclearUnclearYes - except for time since previous relapseYesYesYesYesYesYesYesYesYesFair - due to unclear randomization process and allocation concealment
RRMS+SPMS - MITOXANTRONE
Zipoli, 2008NoNoNo - MITO group had greater % of RRMS and CPA had greater % of SPMS, P<0.001YesNoNoNoNo - 162 enrolled, 153 analyzedNo - different at BLNRYesYesPoor/Fair - open, non-randomized, BL dissimilarity between groups
CIS+RRMS - IFNβ-1b vs GA
Cadavid, 2009
BECOME trial
Unclear - “stratified by clinical site and presence of enhancement on MRI”UnclearYesYesYesNoNoYesUnclearYesUnclearYesFair - unclear randomization or allocation concealment
CIS
Comi, 2009 Europe, Argentina, Australia, New ZealandMethod not describedMethod not describedYesYesYesYesYesYesUnclearYesYesNo - more in treatment group; 39/243 (16%) GA vs 23/238 (9.6%) placeboFair
Pakdaman, 2007
Iran
Method not describedMethod not describedYesUnclear, described as DBUnclear, described as DBUnclear, described as DBNoUnclearYesYesUnclear, numbers NR per groupFair

From: Evidence Tables

Cover of Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis
Drug Class Review: Disease-modifying Drugs for Multiple Sclerosis: Final Update 1 Report [Internet].
Smith B, Carson S, Fu R, et al.
Portland (OR): Oregon Health & Science University; 2010 Aug.
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