Appendix D. Table 1Individual Study Quality for the Dopamine agonist trials

StudyAllocation concealmentBlindingIntention-to treat analysesWithdrawals adequately describedQuality
Bassetti, 20111UnclearDoubleNo, patients required to complete both treatment periods (28 excluded, 42%)YesFair
Benes, 20112AdequateDoubleNo, treatment and post-baseline data required (35 excluded, 13%)YesFair
Högl, 20113UnclearDouble*No, treatment and post-baseline data** required (10 excluded, 3%)No, only due to adverse effectsFair
Montagna, 20114UnclearDouble*No, treatment and post-baseline data required (2 excluded, <1%)YesGood
Hening, 20105AdequateDoubleNo, post-baseline data** required (11 excluded, 2%)YesGood
Oertel, 201035AdequateDoubleNo, 1 excludedYesGood
Ferini-Stambi, 20087AdequateDouble*No, treatment and post-baseline data required (12 excluded, 3%)YesGood
Kushida, 20088UnclearDoubleNo, post-baseline data** required (3 excluded, <1%)No, only due to adverse effectsFair
Trenkwalder, 200810AdequateDoubleNo, post-baseline data** required (11 excluded, 2%)YesGood
Oertel, 20089AdequateDoubleNo, treatment required (8 excluded, 2%)YesGood
Oertel, 200711UnclearDoubleNo, treatment and post-baseline data required (7 excluded, 2%)YesGood
Bogan, 200613AdequateDouble*No, treatment required (1 excluded, <1%)YesGood
Montplaisir, 200614AdequateDouble*YesYesGood
Winkelman, 200615AdequateDoubleNo, post-baseline data required (5 excluded, 1%)YesGood
Adler, 200412AdequateDoubleYesYesGood
Trenkwalder, 200416AdequateDouble*No, treatment required (2 excluded, <1%)YesGood
Walters, 200417Adequate*DoubleYesYesGood

Double blinding denotes participants and investigators

*

plus study team personnel and/or end points adjudicated by blinded committee

**

primary efficacy outcome

noted as adequate based on information in a Cochrane systematic review (Scholz H, Trenkwalder C, Kohnen R, Kriston L, Riemann D, Hornyak M. Dopamine agonists for the treatment of restless legs syndrome. Cochrane Database of Systematic Reviews 2011, Issue 3. Art. No.: CD006009. DOI: 10.1002/14651858.CD006009.pub2). This information was not evident in the trial publication but is presumed to have been obtained directly from the study sponsor.

From: Appendix D, Study Quality/Risk of Bias Tables

Cover of Treatment for Restless Legs Syndrome
Treatment for Restless Legs Syndrome [Internet].
Comparative Effectiveness Reviews, No. 86.
Wilt TJ, MacDonald R, Ouellette J, et al.

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