Appendix C. Abstraction Forms

Suzanne L West; James C Garbutt; Timothy S Carey; Linda J Lux; Anne M Jackman; Sue Tolleson-Rinehart; Kathleen N Lohr; Fulton T Crews

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

West SL, Garbutt JC, Carey TS, et al. Pharmacotherapy for Alcohol Dependence. Rockville (MD): Agency for Health Care Policy and Research (US); 1999 Jan. (Evidence Reports/Technology Assessments, No. 3.)

This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Pharmacotherapy for Alcohol Dependence.

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Appendix C. Abstraction Forms

Adverse Events (AE) for Pharmacologic Treatments of Alcoholism - Abstraction FormProject 6919-105

Adverse Events (AE) for Pharmacologic Treatments of Alcoholism - Abstraction Form Project 6919-105 Appendix C. Abstraction Forms

Table

Adverse Events (AE) for Pharmacologic Treatments of Alcoholism - Abstraction Form Project 6919-105 Appendix C. Abstraction Forms.

Data Extraction Elements for Pharmacotherapies in Alcohol Dependence

I. STUDY CHARACTERISTICS

Name of Reviewer	___ ___ ___	Date	___ ___/___ ___	Unique Article Identifier	\|__\|__\|__\|
	(Initials)		(Mo/Day)		(ProCite #, 3 digits)

Study Design (check one) Randomized controlled trial (traditional methods) Non-randomized controlled trial/Prospective cohort study with concurrent control group Prospective cohort study with historical control group Retrospective cohort study with control group (any type) Case-control Other (describe in space to right) ________________________________________ Not stated

Blinding:	Single	Double	Not stated	None

Length of Efficacy Study
Blinded period of study:		_____	Weeks	Months
Unblinded period of study:		_____	Days	Weeks	Unspecified	None
Total length of Active Drug Treatment:			_____	Weeks	Months
Dose Titration Used?		Yes	No/Not stated

Recruitment Setting:		Inpatient	Outpatient	Not stated
Pre-Treatment:
Detox	Yes	No	Not stated

Abstinent	Yes	No	Not stated
	___	Days	Weeks	Months	Not stated

Psychosocial Treatment Image ftrs_square.jpg Inpatient Day hospital Outpatient Mixed None

Practice Setting:
Number of Sites: ___________

University Affiliation:	Academic	Non-academic	Not stated
Geographic Locale:	United States	Europe	Other	Not stated

Not Stated

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

Compliance with Treatment	Method Used ( all that apply)	Specify Acceptable Range	Measured in Both Placebo and Active ()
Urine marker, e.g., % visits with active drug
Blood levels, e.g., mg/ml
Pill count, e.g., % of drug taken
Self-report of compliance
Proxy report of compliance
Visit attendance, i.e., % visits with appropriate treatment
Other (specify) _____________________________

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? Image ftrs_square.jpg Yes No Not stated

Demographic information for randomized population only.
	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other

History of Alcohol Dependence of Control Group: Not stated

[Control Group]

Age at onset:	Mean ______	Range ______	Std Dev: ______	Not stated
Years since onset of alcohol dependence:	Mean ______	Range ______	Std Dev: ______	Not stated

II. Characteristics of the Study Population

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

[Control Group]

CONTROL Group No Control Group

Drug intervention(s) of Control Group:	Frequency of administration comparable to intervention groups?
Placebo	Yes No
No Drug

Psychosocial intervention(s) of Control Group:	Program Intensity ()
Psychosocial intervention(s) of Control Group:	Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

Total Number of Controls: 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

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

Not stated
Addiction Severity at Study Entry of Control Group	Check all that apply ()

Not stated
Comorbidities of Control Group:	Check all that apply ()	Number	Percentage

Number of Prior Substance Abuse Treatment Experiences of Control Group:

Not measured
Mean _____ Range _____ Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

INTERVENTION Group 1

Drug intervention(s) of Intervention Group 1:	Maximum dose/day	Units	Dosage varies ()
Disulfiram		mg Other (specify) ________________
Naltrexone		mg Other (specify) ________________
Acamprosate		mg Other (specify) ________________
Serotonergic Agent: ___________________________		mg Other (specify) ________________
Lithium (all types)		mg Other (specify) ________________
Placebo		mg Other (specify) ________________

Psychosocial intervention(s) of Intervention Group 1:	Program Intensity ()
Psychosocial intervention(s) of Intervention Group 1:	Required attendance	Encouraged attendance
Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

Total Number of Patients in 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.

	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Control Group: Image ftrs_square.jpg Not stated

Age at onset:	Mean ______	Range ______	Std Dev: ______	Not stated
Years since onset of alcohol dependence:	Mean ______	Range ______	Std Dev: ______	Not stated

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

Not stated
Addiction Severity at Study Entry of Intervention Group 1	Check all that apply ()

Not stated
Comorbidities of Intervention Group 1:	Check all that apply()	Number	Percentage

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

Mean _____

Range _____

Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

INTERVENTION Group 2

Drug intervention(s) of Intervention Group 2:	Maximum dose/day	Units	Dosage varies ()
Disulfiram		mg Other (specify) ________________
Naltrexone		mg Other (specify) ________________
Acamprosate		mg Other (specify) ________________
Serotonergic Agent: __________________________		mg Other (specify) ________________
Lithium (all types)		mg Other (specify) ________________
Placebo		mg Other (specify) ________________

Psychosocial intervention(s) of Intervention Group 2:	Program Intensity ()
Psychosocial intervention(s) of Intervention Group 2:	Required attendance	Encouraged attendance
Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

Total Number of Patients in Intervention Group 2: 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.

	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Intervention Group 2: Image ftrs_square.jpg Not stated

Age at onset:	Mean ______	Range ______	Std Dev: ______	Not stated
Years since onset of alcohol dependence:	Mean ______	Range ______	Std Dev: ______	Not stated

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

Not stated

Not stated
Comorbidities of Intervention Group 2:	Check all that apply ()	Number	Percentage

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

Mean _____ Range _____ Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

INTERVENTION Group 3

Drug intervention(s) of Intervention Group 3:	Maximum dose/day	Units	Dosage varies ()
Disulfiram		mg Other (specify) ________________
Naltrexone		mg Other (specify) ________________
Acamprosate		mg Other (specify) ________________
Serotonergic Agent:		mg Other (specify) ________________
Lithium (all types)		mg Other (specify) ________________
Placebo		mg Other (specify) ________________

Psychosocial intervention(s) of Intervention Group 3:	Program Intensity ()
Psychosocial intervention(s) of Intervention Group 3:	Required attendance	Encouraged attendance
Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract > Yes No Not stated

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.

	N	%	Mean Age	Age SD	% White	% African Americans	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Intervention Group 3: Image ftrs_square.jpg Not stated

Age at onset:	Mean ______	Range ______	Std Dev: ______	Not stated
Years since onset of alcohol dependence:	Mean ______	Range ______	Std Dev: ______	Not stated

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

Not stated

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

Mean _____

Range _____

Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

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

Not Stated

Intervention Group 1

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

Not Stated

Intervention Group 2

Enter information for all outcomes that apply:

Alcohol Intake of Intervention Group 2

Not Stated

Intervention Group 3

Enter information for all outcomes that apply:

Alcohol Intake of Intervention Group 3

Not Stated

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

Category 1: Problem or Question Studied (5 points)

	Not at All	Somewhat	Okay
Alcohol dependence problem clearly stated?	0	1	2
	Little or No	Yes
Significance of alcohol dependence problem discussed?	0	1
	No	Yes
Is research question capable of being answered with the methods proposed?	0	1
	No	Yes
Is the question placed in the broader context of alcohol research?	0	1

Category 2: Sampling (5 points)

	No	Yes
Random allocation of treatment?	0	2
	Unknown or >40%	<40%
Dropout rate of patients invited into the study?	0	1
	No	Yes
Diagnostic criteria clearly specified?	0	1
	No	Yes
Is the sample clearly described?	0	1

Category 3: Measurement (5 points)

	No	Yes
Reliability/validity of the diagnostic measurement tool specified or referenced?	0	1
	No	Yes
Reliability/validity of the outcome measurement tool specified or referenced?	0	2
	No	Yes
Compliance with regimen assessed (pill count, biologic marker, etc.)?	0	1
	No	Yes
Are the outcome measurements clinically relevant?	0	1

Category 4: Internal Validity (5 points)
	No	Yes	NA
Are potential confounding effects addressed (differences between two groups such as age, gender, type of alcohol dependence, other substance abuse)?	0	1
	No	Yes
Was the co-intervention (e.g., psychotherapy) similar between two study groups?	0	1
	No	Yes
Was the co-intervention (e.g., psychotherapy) compliance monitored?	0	1
	No	Yes
Was a concurrent control group present?	0	2

Category 5: External Validity (5 points)
	No	Yes
Do the study conclusions apply to U.S. alcohol-dependent patients?	0	3
	No	Yes
Is the clinical setting specified clearly?	0	2

Category 6: Construct Validity (5 points)
	No	Yes
Appropriate alcohol dependence diagnostic criteria used?	0	2
	No	Yes
Do the measured outcomes relate to the construct of alcohol dependence?	0	2
	No	Yes
Are other variables clearly described in terms of their relationship to alcohol dependence?	0	1

Category 7: Statistical Conclusions (5 points)
	No	Yes	NA
If multiple univariate tests performed, multiple comparisons taken into account?	0	1
	No	Yes
Power analysis performed?	0	1
	No	Yes
In regression analysis, is number of variables in model less than 1/10th of the sample size?	0	1
	No	Yes
Are statistically significant findings clinically significant?	0	1
	No	Yes
Are statistical tests used appropriate to the data?	0	1

Category 8: Justification for Conclusions (5 points)
	No	Yes
Are the conclusions warranted from the data?	0	5

[Comorbid Intervention]

[Control Group]

Reviewer ___ ___ ___	Date ___ ___ / ___ ___	Unique Article ID	\|__\|__\|__\| (ProCite #, 3 digits)
Comorbid Condition:	*depression anxiety other (Specify) _______________*

IIA. CHARACTERISTICS OF THE COMORBID STUDY POPULATION
*(Any control/comparison group should be listed first.)*

COMORBID CONTROL Group No Control Group

Drug intervention(s) of Comorbid Control Group:	Frequency of administration comparable to intervention groups?
Placebo	Yes No
No Drug

Psychosocial intervention(s) of Comorbid Control Group:	Program Intensity ()
Psychosocial intervention(s) of Comorbid Control Group:	Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

Total Number of Comorbid Controls: 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 stated
Dropout due to adverse events:	Number _____	Rate _____	Not stated
Loss to followup:	Number _____	Rate _____	Not stated

Demographic information for randomized population only.

	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Comorbid Control Group: Image ftrs_square.jpg 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:
Image ftrs_square.jpg Not stated Number _____ Percent _____

Not stated

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

Mean _____ Range _____ Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

COMORBID INTERVENTION Group 1

Drug intervention(s) of Comorbid Intervention Group 1:	Maximum dose/day	Units	Dosage varies ()
Disulfiram		mg Other (specify) ______________
Naltrexone		mg Other (specify) ______________
Acamprosate		mg Other (specify) ______________
Serotonergic Agent: _________________		mg Other (specify) ______________
Lithium (all types)		mg Other (specify) ______________
Placebo		mg Other (specify) ______________

Psychosocial intervention(s) of Comorbid Intervention Group 1:	Program Intensity ()
	Required attendance	Encouraged attendance
Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

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.

	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Comorbid Intervention Group 1: Image ftrs_square.jpg 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:
Image ftrs_square.jpg Not stated

Number _____

Percent _____

Not stated

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

Mean _____ Range _____ Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

COMORBID INTERVENTION Group 2

Drug intervention(s) of Comorbid Intervention Group 2:	Maximum dose/day	Units	Dosage varies ()
Disulfiram		mg Other (specify) ______________
Naltrexone		mg Other (specify) ______________
Acamprosate		mg Other (specify) ______________
Serotonergic Agent: _________________		mg Other (specify) ______________
Lithium (all types)		mg Other (specify) ______________
Placebo		mg Other (specify) ______________

Psychosocial intervention(s) of Comorbid Intervention Group 2:	Program Intensity ()
	Required attendance	Encouraged attendance
Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

Total Number of Patients in Comorbid Intervention Group 2: 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 stated
Dropout due to adverse events:	Number _____	Rate _____	Not stated
Loss to followup:	Number _____	Rate _____	Not stated

Demographic information for randomized population only.

	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Comorbid Intervention Group 2: Image ftrs_square.jpg 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:
Image ftrs_square.jpg Not stated

Number _____ Percent _____

Not stated

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

Mean _____ Range _____ Standard deviation _____

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

COMORBID INTERVENTION Group 3

Drug intervention(s) of Comorbid Intervention Group 3:	Maximum dose/day	Units	Dosage varies ()
Disulfiram		mg Other (specify) ______________
Naltrexone		mg Other (specify) ______________
Acamprosate		mg Other (specify) ______________
Serotonergic Agent: _________________		mg Other (specify) ______________
Lithium (all types)		mg Other (specify) ______________
Placebo		mg Other (specify) ______________

Psychosocial intervention(s) of Comorbid Intervention Group 3:	Program Intensity ()
	Required attendance	Encouraged attendance
Alcoholics Anonymous
Group program/counseling
Individualized program/counseling
Family counseling
Unspecified
None
Contract Yes No Not stated

Total Number of Patients in Comorbid 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 stated
Dropout due to adverse events:	Number _____	Rate _____	Not stated
Loss to followup:	Number _____	Rate _____	Not stated

Demographic information for randomized population only.

	N	%	Mean Age	Age SD	% White	% Black	% Hispanic	% Native American	% Other
Total
Males
Females

History of Alcohol Dependence of Comorbid Intervention Group 3: Image ftrs_square.jpg 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:
Image ftrs_square.jpg Not stated

Number _____ Percent _____

Not stated

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

Mean _____ Range _____ Standard deviation _____

COMORBID INTERVENTION Group 3

Patients with prior treatments	Number	Percentage
None
One or More
Unspecified Substance Abuse

IIIa. Comorbid Results

Comorbid Control Group

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Control Group

Not Stated

COMORBID INTERVENTION Group 1

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Intervention Group 1

Not Stated

COMORBID INTERVENTION Group 2

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Intervention Group 2

Not Stated

COMORBID INTERVENTION Group 3

Enter information for all outcomes that apply:

Alcohol Intake of Comorbid Intervention Group 3

Not Stated

[Followup Results]

Reviewer ___ ___ ___	Date ___ ___ / ___ ___	Unique Article ID	\|__\|__\|__\| (ProCite #, 3 digits)
IIIB. FOLLOWUP RESULTS--POST EFFICACY STUDY

What were the changes in outcome(s) that resulted from the intervention for each group during the followup period? 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.

THE ONLY RESULTS TO GO ON THIS FORM APPLY TO THE FOLLOWUP PERIOD.

Length of Post Efficacy Period _____ Weeks Months

Population included in followup period?

Original efficacy population (with some dropouts)
Subgroup (Specify) __________________________________

Followup Control Group

Enter information for all outcomes that apply:

Alcohol Intake of Followup Control Group

Not Stated

FOLLOWUP INTERVENTION Group 1

Enter information for all outcomes that apply:

Alcohol Intake of Followup Intervention Group 1

Not Stated

FOLLOWUP INTERVENTION Group 2

Enter information for all outcomes that apply:

Alcohol Intake of Followup Intervention Group 2

Not Stated

FOLLOWUP INTERVENTION Group 3

Enter information for all outcomes that apply:

Alcohol Intake of Followup Intervention Group 3

Not Stated

Bookshelf ID: NBK32932

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West SL, Garbutt JC, Carey TS, et al. Pharmacotherapy for Alcohol Dependence. Rockville (MD): Agency for Health Care Policy and Research (US); 1999 Jan. (Evidence Reports/Technology Assessments, No. 3.) Appendix C. Abstraction Forms.

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Adverse Events (AE) for Pharmacologic Treatments of Alcoholism - Abstraction FormProject 6919-105
Data Extraction Elements for Pharmacotherapies in Alcohol Dependence
[Comorbid Intervention]
IIIa. Comorbid Results
[Followup Results]

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Pharmacotherapy for Alcohol Dependence.

Appendix C. Abstraction Forms

Adverse Events (AE) for Pharmacologic Treatments of Alcoholism - Abstraction FormProject 6919-105

Table

Data Extraction Elements for Pharmacotherapies in Alcohol Dependence

I. STUDY CHARACTERISTICS

[Control Group]

II. Characteristics of the Study Population

[Control Group]

INTERVENTION Group 1

INTERVENTION Group 2

INTERVENTION Group 3

III. Results

[Control Group]

Intervention Group 1

Intervention Group 2

Intervention Group 3

IV. Study Summary

V. Quality Rating Scale

[Comorbid Intervention]

[Control Group]

COMORBID INTERVENTION Group 1

COMORBID INTERVENTION Group 2

COMORBID INTERVENTION Group 3

COMORBID INTERVENTION Group 3

IIIa. Comorbid Results

Comorbid Control Group

COMORBID INTERVENTION Group 1

COMORBID INTERVENTION Group 2

COMORBID INTERVENTION Group 3

[Followup Results]

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FOLLOWUP INTERVENTION Group 1

FOLLOWUP INTERVENTION Group 2

FOLLOWUP INTERVENTION Group 3

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