Appendix C. Abstraction Forms

I. STUDY CHARACTERISTICS

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Psychosocial Treatment Inpatient Day hospital Outpatient Mixed None

Practice Setting:
Number of Sites: ___________

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Definition of Alcohol Dependence:
(Describe how authors define alcoholism or alcohol dependence. EXCLUDE ARTICLES THAT USE HEAVY SOCIAL DRINKING OR ALCOHOL ABUSE):

• Criteria for Alcohol Dependence Diagnosis:
• DSM-III
• DSM-III-R
• DSM-IV
• ICD-9
• ICD-10
• National Council on Alcoholism
• If none of the above are checked, specify criteria for alcohol dependence diagnosis:

• How were criteria assessed: (Check all that apply)
• Structured interview with individual (self-report) (e.g., SCID)
• Diagnostic Interview Schedule (DIS)
• Computerized Diagnostic Interview Schedule (CDIS)
• Structured interview with proxy
• Clinical observation/interview
• Other (specify) ____________________
• Not stated/Don't know

• Inclusion Criteria
• Age
• Sex
• Medical illnesses (both specified and unspecified)
• Psychiatric illness -> Depression Anxiety
• Laboratory values
• Pattern of alcohol consumption
• Length of abstinence
• Other
• Not stated

• Exclusion Criteria
• Age
• Sex
• Medical illnesses (both specified and unspecified)
• Non-alcohol drug abuse
• Psychiatric illness
• Previous alcoholism treatment
• Current medications
• Laboratory values
• Pregnant/lactating women
• Length of abstinence
• Other
• Not stated

• Author's Definition of Relapse: (Check all that apply)
• Any alcohol consumption
• Number of drinks in a given unit of time (specify) ___________________________
• Number of days of drinking in a given unit of time (specify) ________________________
• Blood alcohol level/Breathalizer
• Other
• Not stated

• How relapse measured: (Check all that apply)
• Structured interview with individual (self-report)
• Unspecified self-report
• Structured interview with proxy
• Clinical observation/interview
• Liver function tests
• Carbohydrate deficient transferrin (CDT)
• Other (specify) _________________
• Not stated
• Not measured

• Craving
• Analog scale
• Ordinal scale
• Other (specify) _____________________________________
• Not stated/Don't know
• Not measured

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Statistical Analysis

• Statistical Methods:
• Student's t-test
• Fisher's Exact Test
• Kaplan Meier
• Chi-square
• ANOVA
• ANACOVA (Analysis of covariance) or ANCOVA
• MANCOVA
• Regression
• Non-parametric tests (Rankings such as Wilcoxen, Mann-Whitney U, etc.)
• Multiple comparisons
• Other (specify) __________
• Not stated

Specifies Intent to Treat Analysis? Yes No Not stated

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History of Alcohol Dependence of Control Group: Not stated

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[Control Group].

II. Characteristics of the Study Population

(Any control/comparison group should be listed first.)

[Control Group]

CONTROL Group No Control Group

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Total Number of Controls: Not stated

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• Dropout:Number _____Rate _____ Not statedDropout due to adverse events:Number _____Rate _____ Not statedLoss to followup:Number _____Rate _____ Not stated

Family History of Alcohol Dependence or Alcoholism of Control Group: Not stated Number ___________ Percent ___________

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Number of Prior Substance Abuse Treatment Experiences of Control Group:

• Not measured
• Mean _____ Range _____ Standard deviation _____

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INTERVENTION Group 1

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Total Number of Patients in Intervention Group 1: Not stated

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• Dropout:Number _____Rate _____ Not statedDropout due to adverse events:Number _____Rate _____ Not statedLoss to followup:Number _____Rate _____ Not stated

Demographic information for randomized population only.

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History of Alcohol Dependence of Control Group: Not stated

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Family History of Alcohol Dependence or Alcoholism of Intervention Group 1:
Not stated Number _____ Percent _____

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Number of Prior Substance Abuse Treatment Experiences of Intervention Group 1:
Not measured

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INTERVENTION Group 2

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Total Number of Patients in Intervention Group 2: Not stated

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• Note: Information on dropouts and loss to followup on randomized subjects only, to explain difference between number entered and final number.
• Dropout:Number _____Rate _____ Not statedDropout due to adverse events:Number _____Rate _____ Not statedLoss to followup:Number _____Rate _____ Not stated

Demographic information for randomized population only.

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History of Alcohol Dependence of Intervention Group 2: Not stated

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Family History of Alcohol Dependence or Alcoholism of Intervention Group 2:
Not stated
Number _____ Percent _____

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Number of Prior Substance Abuse Treatment Experiences of Intervention Group 2:
Not measured

• Mean _____ Range _____ Standard deviation _____

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INTERVENTION Group 3

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Total Number of Patients in Intervention Group 3: Not stated

• Screened _____ Initially entered trial _____ (after randomization) Final number at end of trial _____

• Note: Information on dropouts and loss to followup on randomized subjects only, to explain difference between number entered and final number.
• Dropout:Number _____Rate _____ Not statedDropout due to adverse events:Number _____Rate _____ Not statedLoss to followup:Number _____Rate _____ Not stated

Demographic information for randomized population only.

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History of Alcohol Dependence of Intervention Group 3: Not stated

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Family History of Alcohol Dependence or Alcoholism of Intervention Group 3:
Not stated
Number _____ Percent _____

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Number of Prior Substance Abuse Treatment Experiences of Intervention Group 3:
Not measured

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III. Results

What were the changes in outcome(s) that resulted from the intervention for each group? These should be recorded in units used as the outcome measure(s) (e.g., reduction in the number of standard drinks consumed per time period, time to relapse, number of episodes of heavy drinking per time period, etc.). Any measures of central tendency or dispersion (i.e., standard deviation) should be reported. Test statistics and significance levels should be included.

[Control Group]

CONTROL GROUP Enter information for all outcomes that apply:

Alcohol Intake of Control Group

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Intervention Group 1

Enter information for all outcomes that apply:
Alcohol Intake of Intervention Group 1

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Intervention Group 2

Enter information for all outcomes that apply:

Alcohol Intake of Intervention Group 2

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Intervention Group 3

Enter information for all outcomes that apply:

Alcohol Intake of Intervention Group 3

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IV. Study Summary

Analysis by Groups on Side Effects: (Article must provide a rate or percent by treatment group or have sufficient information so that rates or percents can be calculated in order to check "yes" and flag.)

• Yes (flag article)
• No
• Not stated

Factors Controlled for in the Analysis

• Age
• Sex
• Family history of alcoholism
• Others (Specify) ____________
• Not stated

Limitations Noted in Article by Authors No limitations in the article

• Sub-therapeutic dosing
• Alcohol consumption unverified
• High dropout rate
• Low severity of alcohol dependence
• Compliance problem
• Others (Specify) ____________

Limitations Noted by Reviewer No limitations by reviewer

• Sub-therapeutic dosing
• Alcohol consumption unverified
• High dropout rate
• Low severity of alcohol dependence
• Compliance problem
• Others (Specify) ____________

Conclusions Noted in Article

• Intervention(s) showed efficacy
• Intervention(s) did not show efficacy
• Others (Specify) ____________
• Not stated

Attachments: Comorbid Groups Followup Results

Comments

• Subgroup analysis
• Additional outcomes recorded here

V. Quality Rating Scale

for Alcohol Dependence
Pharmacotherapy Review

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[Control Group]

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COMORBID CONTROL Group No Control Group

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Total Number of Comorbid Controls: Not stated

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Demographic information for randomized population only.

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History of Alcohol Dependence of Comorbid Control Group: Not stated

• Age at onset:Mean ______Range ______Std Dev: ______ Not statedYears since onset of alcohol dependence:Mean ______Range ______Std Dev: ______ Not stated

Family History of Alcohol Dependence or Alcoholism of Comorbid Control Group:
Not stated Number _____ Percent _____

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Number of Prior Substance Abuse Treatment Experiences of Comorbid Control Group:
Not measured

• Mean _____ Range _____ Standard deviation _____

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COMORBID INTERVENTION Group 1

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Total Number of Patients in Comorbid Intervention Group 1: Not stated

• Screened _____ Initially entered trial _____ (after randomization)Final number at end of trial _____
• Note: Information on dropouts and loss to followup on randomized subjects only, to explain difference between number entered and final number.
• Dropout:Number _____Rate _____ Not statedDropout due to adverse events:Number _____Rate _____ Not statedLoss to followup:Number _____Rate _____ Not stated

Demographic information for randomized population only.

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History of Alcohol Dependence of Comorbid Intervention Group 1: Not stated

• Age at onset:Mean ______Range ______Std Dev: ______ Not statedYears since onset of alcohol dependence:Mean ______Range ______Std Dev: ______ Not stated

Family History of Alcohol Dependence or Alcoholism of Comorbid Intervention Group 1:
Not stated

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Number of Prior Substance Abuse Treatment Experiences of Comorbid Intervention Group 1:
Not measured

• Mean _____ Range _____ Standard deviation _____

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COMORBID INTERVENTION Group 2

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Total Number of Patients in Comorbid Intervention Group 2: Not stated

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Demographic information for randomized population only.

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History of Alcohol Dependence of Comorbid Intervention Group 2: Not stated

• Age at onset:Mean ______Range ______Std Dev: ______ Not statedYears since onset of alcohol dependence:Mean ______Range ______Std Dev: ______ Not stated

Family History of Alcohol Dependence or Alcoholism of Comorbid Intervention Group 2:
Not stated

• Number _____ Percent _____

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Number of Prior Substance Abuse Treatment Experiences of Comorbid Intervention Group 2:
Not measured

• Mean _____ Range _____ Standard deviation _____

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COMORBID INTERVENTION Group 3

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Total Number of Patients in Comorbid Intervention Group 3: Not stated

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Demographic information for randomized population only.

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History of Alcohol Dependence of Comorbid Intervention Group 3: Not stated

• Age at onset:Mean ______Range ______Std Dev: ______ Not statedYears since onset of alcohol dependence:Mean ______Range ______Std Dev: ______ Not stated

Family History of Alcohol Dependence or Alcoholism of Comorbid Intervention Group 3:
Not stated

• Number _____ Percent _____

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Number of Prior Substance Abuse Treatment Experiences of Comorbid Intervention Group 3:
Not measured

• Mean _____ Range _____ Standard deviation _____

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COMORBID INTERVENTION Group 3.

Comorbid Control Group

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Control Group

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COMORBID INTERVENTION Group 1

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Intervention Group 1

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COMORBID INTERVENTION Group 2

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Intervention Group 2

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COMORBID INTERVENTION Group 3

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Intervention Group 3

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Followup Control Group

Enter information for all outcomes that apply:

Alcohol Intake of Followup Control Group

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FOLLOWUP INTERVENTION Group 1

Enter information for all outcomes that apply:

Alcohol Intake of Followup Intervention Group 1

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FOLLOWUP INTERVENTION Group 2

Enter information for all outcomes that apply:

Alcohol Intake of Followup Intervention Group 2

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FOLLOWUP INTERVENTION Group 3

Enter information for all outcomes that apply:

Alcohol Intake of Followup Intervention Group 3

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