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Appendix C: Additional Study Characteristics Relevant to Risk of Bias Determinations

Recruitment, randomization, and attrition

Author and year	Treatment	Recruitment method	Was randomization adequate?	Was allocation concealment adequate?	Were groups similar at baseline?	Was there high overall or differential attrition?
Batki et al. 2014	TOP vs. PBO	VA hospital	Yes	Yes	Yes	No
Charney et al. 2015	Citalopram vs. PBO	Academic center, addiction center, and patients	Not well described	Not described	Yes, but citalopram group needed more benzodiazepine treatment before the trial	Yes, high attrition
Chen et al. 2014; Morgenstern et al. 2012	NTX vs. PBO	Online and print advertisements	Yes	Yes	Yes	No
Foa and Williams 2010; Foa et al. 2013; McLean et al. 2014; Zandberg et al. 2016	NTX vs. PBO	Advertisements, anxiety treatment program, and VA hospital	Yes	Not described	More nonwhite subjects in exposure condition	Yes, high attrition
Fridberg et al. 2014; King et al. 2012	NTX vs. PBO	Internet, print, and radio advertisements	Unclear; computer randomized but exact method not specified	Unclear	Unclear	Unclear
Hien et al. 2015	Sertraline vs. PBO	Newspaper and radio advertisements, flyers, and outpatient mental health center referrals	Yes	Yes	Yes	No
Higuchi and Japanese Acamprosate Study Group 2015	Acamprosate vs. PBO	Hospitalized patients referred to study after discharge	Not well described	Yes, independent	Yes	Yes, high attrition but long study duration
Kampman et al. 2013	TOP vs. PBO	Advertisements and professional referrals	Yes	Yes	Yes	Yes, differential attrition that was greater with PBO
Knapp et al. 2015	TOP vs. levetiracetam vs. zonisamide vs. PBO	Radio or newspaper advertisements	Yes	Yes	Yes	No
Kranzler et al. 2014a	TOP vs. PBO	Advertisements	Yes	Yes	Yes, except PBO group slightly older (mean age 52.8 years vs. 49.3 years)	No
Likhitsathian et al. 2013	TOP vs. PBO	Inpatient residential alcohol treatment program	Yes	Yes	Yes	Yes; high attrition
Mason et al. 2014	Gabapentin vs. PBO	Print and Internet advertisements	Yes	Yes	Yes	No
Oslin et al. 2015	NTX vs. PBO	Advertisements, physician referrals, and self-referrals	Yes, block randomization created prior to study	Yes	Yes	No
Yoshimura et al. 2014	DIS vs. PBO	Recruited during 2- to 3-month inpatient stay	Not described	Psychosocial treatment status known to patient	Yes	No
Note. Abbreviations: DIS = disulfiram; NTX = naltrexone; PBO = placebo; TOP = topiramate; VA = U.S. Department of Veterans Affairs.

Recruitment, randomization, and attrition

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Intervention fidelity, adherence, and masking

Author and year	Was intervention fidelity adequate?	Was adherence to the intervention adequate?	Were outcome assessors masked?	Were care providers masked?	Were patients masked?
Batki et al. 2014	Yes	No; only 63% adherent to total prescribed dose	Yes	Yes	Yes
Charney et al. 2015	Yes	Not described	Yes	Yes	Yes
Chen et al. 2014; Morgenstern et al. 2012	Yes	Yes	Yes (for NTX)	Yes (for NTX)	Yes (for NTX)
Foa and Williams 2010; Foa et al. 2013; McLean et al. 2014; Zandberg et al. 2016	Yes	Yes	Yes	Yes for NTX condition	Yes for NTX condition
Fridberg et al. 2014; King et al. 2012	Yes	Yes	Yes	Yes	Yes
Hien et al. 2015	Yes	Yes	Yes	Yes	Yes
Higuchi and Japanese Acamprosate Study Group 2015	Yes	Yes	Yes	Yes	Yes
Kampman et al. 2013	Yes	Yes	Yes	Yes	Yes
Knapp et al. 2015	No	Yes	NR	NR	NR
Kranzler et al. 2014a	No	Yes	Yes	Yes	Yes
Likhitsathian et al. 2013	Yes	Yes	Yes	Yes	Yes
Mason et al. 2014	Yes	Yes	Yes	Yes	Yes
Oslin et al. 2015	Yes	Yes; but less with Asp40/NTX than Asn40/NTX group	Yes	Yes	Yes
Yoshimura et al. 2014	Yes	Yes	Yes	Yes	No
Note. Abbreviations: NR = not reported; NTX = naltrexone.

Intervention fidelity, adherence, and masking

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Outcome characteristics, statistical methods, and risk of bias

Author and year	Were outcome measures equal, valid, and reliable?	Did the study have cross-overs or contamination raising concern for bias?	Did the study use acceptable statistical methods?	Was an appropriate method used to handle missing data?	Risk of bias
Batki et al. 2014	Yes	No	Yes	Yes	Low
Charney et al. 2015	Yes	No	Yes	Yes	Moderate
Chen et al. 2014; Morgenstern et al. 2012	Yes	No	Yes	Not needed because < 1% of data was missing	Moderate
Foa and Williams 2010; Foa et al. 2013; McLean et al. 2014; Zandberg et al. 2016	Yes	No	Yes	Yes	Moderate
Fridberg et al. 2014; King et al. 2012	Yes	No	Yes	Yes	Moderate
Hien et al. 2015	Yes	No	Yes	Yes	Low
Higuchi and Japanese Acamprosate Study Group 2015	Yes	No	Unclear	Unclear	Low
Kampman et al. 2013	Yes	No	Yes	Yes	Low
Knapp et al. 2015	Yes	No	Yes	Yes	Moderate
Kranzler et al. 2014a	Yes	No	Yes	Yes	Low
Likhitsathian et al. 2013	Yes	No	Yes	Yes	Moderate
Mason et al. 2014	Yes	No	Yes	Yes	Low
Oslin et al. 2015	Yes	No	ITT	Yes	Low
Yoshimura et al. 2014	Yes	No	Yes	Not stated	Moderate
Note. Abbreviations: ITT = intention to treat.

Outcome characteristics, statistical methods, and risk of bias

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Study harms

Author and year	Were harms prespecified and defined?	Were ascertainment techniques for harms adequately described?	Were ascertainment techniques for harms equal, valid, and reliable?	Was the duration of follow-up adequate for harms assessment?
Batki et al. 2014	Yes	Yes	Yes	Yes
Charney et al. 2015	Not well described	Not well described	Unclear	Yes
Chen et al. 2014; Morgenstern et al. 2012	No	No	Unclear	Yes
Foa and Williams 2010; Foa et al. 2013; McLean et al. 2014; Zandberg et al. 2016	No	No	Not specified	Yes
Fridberg et al. 2014; King et al. 2012	No	No	No	Yes
Hien et al. 2015	Not applicable	Not applicable	Not applicable	Not applicable
Higuchi and Japanese Acamprosate Study Group 2015	No	Not well described	Not well described	Yes
Kampman et al. 2013	Yes	Yes	Yes	Yes
Knapp et al. 2015	Yes	Yes	Yes	Yes
Kranzler et al. 2014a	No	No	Unclear	Yes
Likhitsathian et al. 2013	Yes	Yes	Yes	Yes
Mason et al. 2014	Yes	Yes	Yes	Yes
Oslin et al. 2015	Unclear	No	Unclear	Unclear
Yoshimura et al. 2014	No	Yes	Yes	Yes

Study harms

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The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder

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History

Published online 5 January 2018

Published in print 5 January 2018

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Appendix C: Additional Study Characteristics Relevant to Risk of Bias Determinations

Recruitment, randomization, and attrition

Author and year

Treatment

Recruitment method

Was randomization adequate?

Was allocation concealment adequate?

Were groups similar at baseline?

Was there high overall or differential attrition?

Recruitment, randomization, and attrition

Intervention fidelity, adherence, and masking

Author and year

Was intervention fidelity adequate?

Was adherence to the intervention adequate?

Were outcome assessors masked?

Were care providers masked?

Were patients masked?

Intervention fidelity, adherence, and masking

Outcome characteristics, statistical methods, and risk of bias

Author and year

Were outcome measures equal, valid, and reliable?

Did the study have cross-overs or contamination raising concern for bias?

Did the study use acceptable statistical methods?

Was an appropriate method used to handle missing data?

Risk of bias

Outcome characteristics, statistical methods, and risk of bias

Study harms

Author and year

Were harms prespecified and defined?

Were ascertainment techniques for harms adequately described?

Were ascertainment techniques for harms equal, valid, and reliable?

Was the duration of follow-up adequate for harms assessment?

Study harms