Appendix C: Additional Study Characteristics Relevant to Risk of Bias Determinations
| 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.
| 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.
| 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.
| 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 |
Information & Authors
Information
Published In
The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder
January 2018
©American Psychiatric Association Publishing
Authors
Metrics & Citations
Metrics
Citations
If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download.
For more information or tips please see 'Downloading to a citation manager' in the Help menu.
View Options
View options
Login options
Already a subscriber? Access your subscription through your login credentials or your institution for full access to this article.
Personal login Institutional Login Open Athens loginNot a subscriber?
PsychiatryOnline subscription options offer access to the DSM-5-TR® library, books, journals, CME, and patient resources. This all-in-one virtual library provides psychiatrists and mental health professionals with key resources for diagnosis, treatment, research, and professional development.
Need more help? PsychiatryOnline Customer Service may be reached by emailing [email protected] or by calling 800-368-5777 (in the U.S.) or 703-907-7322 (outside the U.S.).