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Mulrow CD, Williams JW Jr, Trivedi M, et al. Treatment of Depression: Newer Pharmacotherapies. Rockville (MD): Agency for Health Care Policy and Research (US); 1999 Feb. (Evidence Reports/Technology Assessments, No. 7.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

Cover of Treatment of Depression: Newer Pharmacotherapies

Treatment of Depression: Newer Pharmacotherapies.

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Appendix 2: Abstraction Form and Data Dictionary

  • Contents:
  • 2.1 Abstraction Form
  • 2.2 Data Dictionary

2.1 Article Abstraction Form DEPRESSION

CODES FOR STUDIES AND REVIEWERS

AuthorStudy Unique Identifier
JournalCountry
Year Publication(where study performed)
Reviewer
Funding Source:GovernmentPharmaceuticalPrivateUnclear

VERIFICATION/SELECTION OF STUDY ELIGIBILITY (circle one)

Was randomizedYesNoUnclear
Evaluates newer drug therapyYesNoUnclear
Target depression disorder:YesnoUnclear
(Major or minor depression, or dysthymia, or adjustment disorder, post partum depression, atypical depression, seasonal affective disorder(see glossary)
Did not include more than 10% of Bipolar Dis.YesNoUnclear
Treatment duration > 6 wksYesNoUnclear
Stop if any of above is "NO"

METHODS

Study Design and Conduct (circle one)
Placebo ControlledYesNoUnclear
Crossover TrialYesNoUnclear
Subjects BlindedYesNoUnclear
Providers BlindedYesNoUnclear
Outcome Assessors BlindedYesNoUnclear
Combination TherapyYesNoUnclear
Multicenter TrialYesNoUnclear
Continuation or Maintenance RCT YesNoUnclear

Randomization and Allocation Concealment Method (circle one):

A = Clearly Adequate: Centralized randomization by telephone; randomization scheme controlled by pharmacy; numbered or coded identical containers administered sequentially; on-site computer system which can only be accessed after entering the characteristics of an enrolled participant; sequentially numbered, sealed, opaque envelopes.

B = Possibly Adequate: Sealed envelopes but not sequentially numbered or opaque; list of random numbers read by someone entering patient into trial (open list); a trial in which the description suggests adequate concealment, but other features are suspicious (for example: markedly unequal controls and trial groups; stated random, but unable to obtain further details).

C = Clearly Inadequate: Any allocation procedure transparent before assignment (for example: an open list of random numbers, alternation, date of birth, day of week, case record number).

D = Not described

DIAGNOSTIC CRITERIA;

Method of diagnosis:
DSMIVYesNo
DSMIIIRYes No
DSMIIIYes No
RDCYes No
EndicottYes No
FeighnerYes No
NewcastleYes No
Other (specify): _____________

Was functional impairment required for diagnosis?

Yes No How assessed___________________________

Includes Patients with which of the following? (see definitions in glossary) If yes or no, write n/N.

n/N
Depression w/PsychosisYesNot Stated/Unclear
Major DepressionYesNot Stated/Unclear
Minor DepressionYesNot Stated/Unclear
DysthymiaYesNot Stated/Unclear
Adjustment DisorderYesNot Stated/Unclear
Double Depression (major depression+dysthymia)YesNot Stated/Unclear
Depression NOSYesNot Stated/Unclear
Unclassified DepressionYesNot Stated/Unclear
Atypical DepressionYesNot Stated/Unclear
MelancholiaYesNot Stated/Unclear
Postpartum DepressionYesNot Stated/Unclear
Seasonal Affective DisorderYesNot Stated/Unclear
Bipolar DisorderYesNot Stated/Unclear
Currently present: (Not life time prevalence)
PTSDYesNot Stated/UnclearExclude
AlcoholismYesNot Stated/UnclearExclude
Other Substance AbuseYesNot Stated/UnclearExclude
Personality DisorderYesNot Stated/UnclearExclude
Anxiety DisorderYesNot Stated/UnclearExclude
Panic DisorderYesNot Stated/UnclearExclude
Significant co-existing chronic condition
Severe medical or somatic illnessYesNot Stated/UnclearExclude
StrokeYesNot Stated/UnclearExclude
Myocardial InfarctionYesNot Stated/UnclearExclude
HypertensionYesNot Stated/UnclearExclude
Diabetes MellitusYesNot Stated/UnclearExclude
CancerYesNot Stated/UnclearExclude
COPDYesNot Stated/UnclearExclude
HIVYesNot Stated/UnclearExclude
Cognitive impairmentYesNot Stated/UnclearExclude
How defined:
DementiaYesNot Stated/UnclearExclude
How defined:
Mental RetardationYesNot Stated/UnclearExclude
How defined:
Known Tx FailureYesNot Stated/UnclearExclude
How defined:
Known Previous partial responderYesNot Stated/UnclearExclude
How defined:
Two or more prior episodes of depressionYesNot Stated/UnclearExclude
How defined:
On Recent TherapyYesNot Stated/UnclearExclude
How defined:
OtherYesNot Stated/UnclearExclude

Recruitment Settings: (circle all that apply in each category)

1.

Primary care

2.

Mental Health Specialty Care

3.

University Affiliated

4.

Community Clinic/Government Clinic

5.

Private Clinic

6.

Outpatient clinic

7.

Inpatient

8.

Advertisement (media, newspaper, radio)

9.

Not stated/Unclear

Treatment Settings: (circle all that apply in each category)

1.

Primary care

2.

Mental Health Specialty Care

3.

University Affiliated

4.

Community Clinic/Government Clinic

5.

Private Clinic

6.

Outpatient clinic

7.

Inpatient

8.

Not stated/Unclear

Intervention

Check types of intervention per group in the following order:
Placebo (is always group 1), new antidepressant(alphabetic order), old antidepressant(alphabetic order), psychotherapy, combination

GROUP 1GROUP 2GROUP 3GROUP 4
Image ftrs_rect.jpg Placebo Image ftrs_rect.jpg Placebo Image ftrs_rect.jpg Placebo Image ftrs_rect.jpg Placebo
Image ftrs_rect.jpg New Antidepressant Image ftrs_rect.jpg New Antidepressant Image ftrs_rect.jpg New Antidepressant Image ftrs_rect.jpg New Antidepressant
Image ftrs_rect.jpg Other Antidepressant Image ftrs_rect.jpg Other Antidepressant Image ftrs_rect.jpg Other Antidepressant Image ftrs_rect.jpg Other Antidepressant
Image ftrs_rect.jpg New Antidepressant Image ftrs_rect.jpg New Antidepressant Image ftrs_rect.jpg New Antidepressant Image ftrs_rect.jpg New Antidepressant
Image ftrs_rect.jpg Other Antidepressant Image ftrs_rect.jpg Other Antidepressant Image ftrs_rect.jpg Other Antidepressant Image ftrs_rect.jpg Other Antidepressant
Image ftrs_rect.jpg Psychotherapy Image ftrs_rect.jpg Psychotherapy Image ftrs_rect.jpg Psychotherapy Image ftrs_rect.jpg Psychotherapy
Image ftrs_rect.jpg Combination
Image ftrs_square.jpg Augment Med
Image ftrs_square.jpg Drug Assoc Sx
Image ftrs_rect.jpg Combination
Image ftrs_square.jpg Augment Med
Image ftrs_square.jpg Drug Assoc Sx
Image ftrs_rect.jpg Combination
Image ftrs_square.jpg Augment Med
Image ftrs_square.jpg Drug Assoc Sx
Image ftrs_rect.jpg Combination
Image ftrs_square.jpg Augment Med
Image ftrs_square.jpg Drug Assoc Sx
Image ftrs_rect.jpg Other Image ftrs_rect.jpg Other Image ftrs_rect.jpg Other Image ftrs_rect.jpg Other

RUN-IN
Yes No

  • If yes:
  • Washout
  • Exclude patients with placebo response

UI
Delivery of Psychotherapy Intervention (circle all that apply)
Planned Duration treatmentweeks
Planned Follow-upweeks
52 weeks=1 year
26 weeks=6 months
12 weeks=3 months
Group 1Group 2Group 3Group 4
Group 1Group 2Group 3Group 4
Drug name
Minimim target dose
Maximal dose
Average dose at study end
Adherence (pill count)
Content of Follow up visit
1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Clinical visits with provider

5.

Other

6.

Unclear

1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Clinical visits with provider

5.

Other

6.

Unclear

1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Clinical visits with provider

5.

Other

6.

Unclear

1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Clinical visits with provider

5.

Other

6.

Unclear

Main Provider
1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

Total Planned No. visits
Total number of visits attended
Frequency of follow up visit
1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

UI
Delivery of Psychotherapy Intervention (circle all that apply)
Planned Duration treatmentweeks
Planned Follow-upweeks
52 weeks=1 year
26 weeks=6 months
12 weeks=3 months
Group 1Group 2Group3Group4
Group 1Group 2Group3Group4
Psychotx
1.

Cognitive Ther

2.

Interpersonal ther

3.

Behavior Ther

4.

Cognitive-Beh Ther

5.

Problem Solving

6.

Rational Emot Ther

7.

Brief Psyc

8.

Ext Fam Syst

9.

Feminist Ther

10.

Reality Ther

11.

Adlerian Psych

12.

Analytical Psycho

13.

Client-centTher

14.

Other

15.

Not given/Unclear

  1. Cognitive Ther
  2. Interpersonal ther
  3. Behavior Ther
  4. Cognitive-Beh Ther
  5. Problem Solving
  6. Rational Emot Ther
  7. Brief Psyc
  8. Ext Fam Syst
  9. Feminist Ther
  10. Reality Ther
  11. Adlerian Psych
  12. Analytical Psycho
  13. Client-centTher
  14. Other
  15. Not given/Unclear
1.

Cognitive Ther

2.

Interpersonal ther

3.

Behavior Ther

4.

Cognitive-Beh Ther

5.

Problem Solving

6.

Rational Emot Ther

7.

Brief Psyc

8.

Ext Fam Syst

9.

Feminist Ther

10.

Reality Ther

11.

Adlerian Psych

12.

Analytical Psycho

13.

Client-centTher

14.

Other

15.

Not given/Unclear

1.

Cognitive Ther

2.

Interpersonal ther

3.

Behavior Ther

4.

Cognitive-Beh Ther

5.

Problem Solving

6.

Rational Emot Ther

7.

Brief Psyc

8.

Ext Fam Syst

9.

Feminist Ther

10.

Reality Ther

11.

Adlerian Psych

12.

Analytical Psycho

13.

Client-centTher

14.

Other

15.

Not given/Unclear

Social
1.

Case management

2.

Supportive tx

3.

Education

1.

Case management

2.

Supportive tx

3.

Education

1.

Case management

2.

Supportive tx

3.

Education

1.

Case management

2.

Supportive tx

3.

Education

Other
1.

Exercise

1.

Exercise

1.

Exercise

1.

Exercise

Format
1.

Individual

2.

Group cons

3.

Family Couns

4.

Telephone

5.

Self Help Material

6.

Unclear

7.

Other

8.

Not given/Unclear

1.

Individual

2.

Group cons

3.

Family Couns

4.

Telephone

5.

Self Help Material

6.

Unclear

7.

Other

8.

Not given/Unclear

1.

Individual

2.

Group cons

3.

Family Couns

4.

Telephone

5.

Self Help Material

6.

Unclear

7.

Other

8.

Not given/Unclear

1.

Individual

2.

Group cons

3.

Family Couns

4.

Telephone

5.

Self Help Material

6.

Unclear

7.

Other

8.

Not given/Unclear

Main Provider
1.

None

2.

Primary Care MD

3.

Pychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

Total Planned
No. visits
Total number visits attended
Frequency
1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

Weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

Weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

Weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

Weekly

8.

Daily

9.

Other

10.

Not given/Unclear

Image ftrs_square.jpgBenzodiazepine Image ftrs_square.jpgAdjuvantPsychotherapy
Total # of patientsTotal # of patientsTotal # of patients
Group 1 Image ftrs_rect.jpg Group 1 Image ftrs_rect.jpg Group 1 Image ftrs_rect.jpg
Group 2 Image ftrs_rect.jpg Group 2 Image ftrs_rect.jpg Group 2 Image ftrs_rect.jpg
Group 3 Image ftrs_rect.jpg Group 3 Image ftrs_rect.jpg Group 3 Image ftrs_rect.jpg
Group 4 Image ftrs_rect.jpg Group 4 Image ftrs_rect.jpg Group 4 Image ftrs_rect.jpg
Image ftrs_square.jpgHypnotics Image ftrs_square.jpgDepressive/Drug Assoc Sx. Image ftrs_square.jpgOther
Total # of patientsTotal # of patientsTotal # of patients
Group 1 Image ftrs_rect.jpg Group 1 Image ftrs_rect.jpg Group 1 Image ftrs_rect.jpg
Group 2 Image ftrs_rect.jpg Group 2 Image ftrs_rect.jpg Group 2 Image ftrs_rect.jpg
Group 3 Image ftrs_rect.jpg Group 3 Image ftrs_rect.jpg Group 3 Image ftrs_rect.jpg
Group 4 Image ftrs_rect.jpg Group 4 Image ftrs_rect.jpg Group 4 Image ftrs_rect.jpg
PARTICIPANTS
Group 1 Group 2 Group 3 Group 4 Overall
Tx Description
Age range
Mean Age
Male/Female(n)
Caucasian
African American
Hispanic
Oriental
Other

Population Type:
Education Measure Yes / No
Describe:

Soc Ec. Measure Yes / No
Describe:

Duration of present depression period (duration of illness):

Adverse Effects

Side effects assessedYesNo
If yes, how:Standardized probedVoluntary reporting
a. Scale(score and rate the severity)Unclear
b. ChecklistNot stated
c. Generic questionOther
Group number
Number of patients evaluated
Group 1
N=
Group 2
N=
Group 3
N=
Group 4
N=
Overall
N=
n (numerator), N ( denominator)nNnNnNnNnN
Any side effect
ANTICHOLINERGIC
Dry mouth
Blurred vision
Urinary disturbance
Constipation
Sweating
CNS
Drowsiness
Agitation
Akathisia
Nervousness
Seizures
Dizziness
Fatigue
Insomnia
Anxiety
Headache
Tremor
CARDIOVASCULAR
Arrhythmia
Orthostatic
hypotension
Palpitations
ENDOCRINE
GASTRO INTESTINAL
Nausea
Anorexia
Diarrhea
OTHER
Thirst
Wt. Gain
Wt. Loss
Suicidal attempts
Suicide
SEXUAL DYSFUNCTION
Decreased libido
Premature ejaculation
DROPOUTS to specific primary outcome affect measure
Group 1Group 2Group 3Group 4Overall
Total enrolled
If Run-in Period
Dropout
Run -In
Total
Randomized
Dropout
Side Effects
Dropout Failure,
Lack of Effect,
Worsening Sympt.
Dropout
Other
Total
dropouts
Crossover dropouts

Outcomes and Results

UI_______
BaselineWithin Treatment
weeks
Within Treatment
weeks
End of Treatment
weeks
Other
(e.g. within, or maintenance or follow up)
weeks
Outcome*:_______________________________________________ No. items_______________________________________
(*If functional status or social outcomes, only abstract the following: SF-36, Social Assessment Scale Modified (SAS-M), Sickness Impact Profile (SIP), Endicott Quality of Life, Global Assessment Scale, ......)
How was outcome measured? (Circle one)
a. Self administeredb. Clinician administeredc. not described d. other _________________
How was outcome reported?
1.

mean

2.

median

3.

mean change

4.

median change

e. response rate to tx.
1.

20 - 25% reduction

2.

50% 43euction

3.

75% reduction

4.

Any improvement (e.g. CGI) Define

5.

Much or very much improved (e.g. same as response of 1 or 2 in CGI score)

6.

Cure: Define

7.

Other

6.

% reduction

7.

graphical

8.

not given

9.

other

(enter code letter in the corresponding column below)
How was variance reported? (Not applicable if outcome reported as response rate)
1.

Standard deviation

2.

Standard error mean

3.

Confidence interval

4.

Range

5.

not given

6.

other

(enter code letter in the corresponding column below)

Group Comparison Table

GroupsOutcome AssessedMeasurement Timep-valueConfidence IntervalStatistical TestObserved ValueDegree of Freedom

vs

vs

vs

vs

vs

vs

vs

Comments

Designs and Methods
Diagnostic criteria
Inclusion and Exclusion
Intervention:
Co-interventions:
Participants:
Dropouts:
Side effects:
Outcomes:

Do investigators need to be contacted for more information?
YES NO (If yes, which data should be obtained?)
Reference of Interest:

UI
Delivery of Maintenance Intervention (circle all that apply)

Planned Duration treatmentweeks

Planned Follow-upweeks
52 weeks=1 year
26 weeks=6 months
12 weeks=3 months
Group 1Group 2Group 3Group 4
Group 1Group 2Group 3Group 4
Drug name
Minimim target dose
Maximal dose
Average dose at study end
Adherence (pill count)
Format
1.

Individual

2.

Telephone

3.

Self Help Material

4.

Mail

5.

Pharmacy pick up

6.

Other

7.

Not given/Unclear

1.

Individual

2.

Telephone

3.

Self Help Material

4.

Mail

5.

Pharmacy pick up

6.

Other

7.

Not given/Unclear

1.

Individual

2.

Telephone

3.

Self Help Material

4.

Mail

5.

Pharmacy pick up

6.

Other

7.

Not given/Unclear

1.

Individual

2.

Telephone

3.

Self Help Material

4.

Mail

5.

Pharmacy pick up

6.

Other

7.

Not given/Unclear

Content of Follow up visit
1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Not given/Unclear

1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Not given/Unclear

1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Not given/Unclear

1.

Assessment only

2.

Self help material and/or education provided

3.

Titration based on symptoms (not fixed)

4.

Not given/Unclear

Main Provider
1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

1.

None

2.

Primary Care MD

3.

Psychiatrist

4.

Psychologist

5.

Social Worker

6.

Case manager

7.

Nurse

8.

Research Associate

9.

Other

10.

Not given/Unclear

Total Planned No. visits
Total number of visits attended
Frequency of follow up visit
1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

1.

None

2.

1 time only

3.

Monthly

4.

2 time a week

5.

3--5 times wk

6.

Biweekly

7.

weekly

8.

Daily

9.

Other

10.

Not given/Unclear

2.2 Data Dictionary

Codes for Study and Reviewer

  • Study ID:
  • This field will appear automatically as you create or enter a new record; this refers to the record number in the data base.
  • Author:
  • First author's last name
  • Journal:
  • The name of the journal where the study was published
  • Year Publication:
  • Year of publication, e.g. "1972"
  • Reviewer:
  • Initials of the reviewers' or reviewer code. This field is "Final" once consensus between abstractors has been obtained.
  • Study Number:
  • Each article that is abstracted will have a unique identifier number that has already been previously assigned by CCDAN/ ProCite database. For studies that have several publications, please be sure to enter all the Study Number.
  • Country:
  • State country or countries where this study was performed.
  • Funding Source:
  • State the different possibilities of funding source: a. government, b. pharmaceutical, c. private (foundation or university), d. unclear. Example: "completion of this study was supported by Pfizer" would suggest funding from pharmaceutical company. For any kind of support from a pharmaceutical company, we code "pharmaceutical."

VERIFICATION/SELECTION OF STUDY ELIGIBILITY (circle one)

In this section, please state yes or no for verification and selection of study eligibility. In order for a study to be eligible, all statements should be yes or unclear. The program has a default YES for these five different eligibility criteria. If any of statements is NO, the study will not be eligible. If you are in doubt about the eligibility of the study, please always ask.

Determine if the study was randomized (random or chance assignment to treatment) or newer drug therapy. Medications in the following list are considered new drug therapy:

VERIFICATION/SELECTION OF STUDY ELIGIBILITY (circle one)

amilsupride brofaromine
bupropion citalopram
felsinoxan femoxetine
fengabine fluoxetine
fluvoxamine gepirone
hypericum indalpine
ipsapirone kava kava
litoxetine medifoxamine
milnacipran minaprine
mirtazapine moclobemide
nefazodone paroxetine
reboxetine ritanserin
sertraline sulpiride
tandospirone temoxetine
toloxatone valeriana
venlafaxine viloxazine

Major or minor depression or dysthymia, adjustment disorder, postpartum depression, atypical depression, seasonal affective disorder. (refer to glossary for the definitions of the disorders).

Did not include more than 10% of bipolar disorder. Make pertinent calculations; if article has more than 10% of subjects that are bipolar, EXCLUDE.

Treatment duration for the total amount of intervention has to be greater than or equal to 6 weeks.

METHODS

Study Design and Conduct:: Only state Yes, No or unclear if clearly stated in the publication methods section.

Placebo controlled:: The design included a placebo group.

Crossover study:: A study in which subjects receive one intervention for a designated period and, usually after a washout period, another intervention for an additional designated period; the patient or subject serves as his own control.

Subjects blinded:: When participants are not aware of the treatment they are assigned to.

Provider blinded:: When providers are not aware of the treatment the subjects are assigned to.

Outcome assessors blinded:: When the person (may be the provider) assessing the different scales or assessments are not aware of the treatment the subject are assigned to. If study describes a double blinded fashion, assume that outcome assessors are blinded in conjunction with subjects and providers.

Combination therapy is defined as:: Two antidepressants, or one antidepressant plus psychotherapy, compared to one antidepressant or placebo.

Multicenter:: This refers to where the intervention was delivered (multiple sites); this does not refer to recruitment sites.

Maintenance trial:: Subjects of a previous intervention within a research environment are randomized in a maintenance study (aimed at preventing recurrences after cure has occurred) or continuation study (preventing relapse).

Randomization and Allocation Concealment Method (circle one):: Determine how randomization and concealment was done in the study following the description below.

A = Clearly Adequate:: Centralized randomization by telephone; randomization scheme controlled by pharmacy; numbered or coded identical containers administered sequentially; on-site computer system which can only be accessed after entering the characteristics of an enrolled participant; sequentially numbered, sealed, opaque envelopes.

B = Possibly Adequate:: Sealed envelopes but not sequentially numbered or opaque; list of random numbers read by someone entering patient into trial (open list); a trial in which the description suggests adequate concealment, but other features are suspicious (for example: markedly unequal controls and trial groups; stated random, but unable to obtain further details).

C = Clearly Inadequate:: Any allocation procedure transparent before assignment (for example: an open list of random numbers, alternation, date of birth, day of week, case record number).

D = Not described;: the vast majority of trials do not describe how randomization was conducted, this is commonly entered.

Diagnostic Criteria (circle all that apply)

Determine which diagnostic criteria from the given list was used in the study, as well as type of assessment and score used to establish entry criteria for the study, if the diagnostic criteria is not in the list please check other and enter in box the diagnostic criteria used. Answer yes only if a clear and precise definition was given, this means if the study spelled out the name of the diagnostic criteria used ONLY.

Example:

  • Study reads:
  • According to DSM III-R and scoring a minimum of 18 points on the 17 item HAM-D were included.
  • Data entry would be as follows:
  • Check for DSM III-R
  • Check Other, and also type in box HAM-D (17 item) ≥18.

Was functional impairment required for diagnosis?

An assessment of whether the depressive symptoms cause significant distress or impairment in social, occupational or other important areas of functioning. Please answer yes or no, and describe how it was assessed.

If DSMIV was used for diagnostic criteria than functional impairment was required for diagnosis and this field should be "Yes." Program has an automatic default for NO.

Includes patients with the following

Please enter Yes, and enter the number of patients that were included in the study with the different following disorders. Be sure that you enter the number of patients with the different diagnosis. For example: the study had 139 patients with major depression, but they also had melancholia (20) and bipolar (6). You enter major depression 139/139, melancholia 20/139, and bipolar 6/139. Not stated means that it was not explicitly stated as an inclusion or exclusion. Electronic version has a default of Not stated/Unclear.

Special Notes

Currently present: in contrast to lifetime prevalence. If article states: excluded psychiatric disorders, it is assumed that PTSD, Personality, Anxiety, and Panic disorder are excluded.

Other substance abuse

Determine the amount of patients that were included or excluded in the study that had for example any the following substance abuse: marijuana, cocaine, crack.

Personality disorders: This includes all the different personality clusters that were included or excluded: A. Paranoid, schizoid, schizotypal, B. histrionic, narcissistic, antisocial, C. avoidant, dependent, obsessive-compulsive

Significant co-existing medical chronic illness

Define whether participants were included or excluded because they had severe medical or somatic illness. If study states different type of comorbid diseases, keep in mind the following diseases: Stroke, MI, HTN, Diabetes, Cancer, COPD, HIV. Chronic illness such as hyperthyroidism, liver disease, renal disorders, cardiac impairment, arrhythmia, are entered on the line of Severe medical or somatic illness as general. If article states that cardiovascular diagnosis were excluded, it is assumed that participants with history of stroke, hypertension and myocardial infarction were excluded.

Cognitive Impairment

Please enter definition used in the study and determine if patients were included or excluded. If included enter the total number of patients with the condition.

Dementia

Please enter definition used in the study and determine if patients were included or excluded. If article states that excluded DSM III R other diagnosis than it is assumed that dementia was excluded. If included enter the total number of patients with the condition.

Mental retardation

Please enter definition used in the study and determine whether patients were included or excluded. If article states that excluded DSM III R other diagnosis then it is assumed that mental retardation is excluded.

Known treatment failure

Patients who failed initial therapy and are now included or excluded into the study, also please define the type of treatment they failed for example: ECT, TCA, Psychotherapy, other.

Known previous partial responder

Please enter definition used in the study and determine if included or not.

Two or more prior episodes of depression

Did the study include or exclude subjects that had more than two prior episodes of depression? Enter yes, and number of subjects included, or if this was excluded.

Recent therapy

Any kind of recent therapy that the study included or excluded for example; antidepressants, monoamine oxidase agents in the past 2 weeks, 4 weeks, etc.; ECT in the past year; other psychotropic treatment.

Setting

Recruitment Settings

Determine kind of setting where recruitment took place. You will find this information in the methods. Please check all that apply. Note: Assume general practice setting to be equivalent to primary care setting.

Treatment Setting

Determine where intervention, was conducted, please check all that apply. You might find this information in the description of the intervention or in the methods section.

Run In

Please check if study had a run-in period; then specify the purpose of the run-in: washout and/or exclude responders.

Education

Answer yes or no if measured; write how it was measured. Education can be measured by different levels or categories. Please enter in the format that the information is given per group. Electronic version has default NG.

Social Economic Status

Answer yes or no if measured, as well as how it was measured. This can be measured by income, class, etc. Example: This may be labeled Social class I, II, III in some European studies, or by level of income less $25,000, $25-35,000, $35-40,000, or by level of education, or work status. Please enter in format that the information is given per group. Electronic version has default NG

Duration of illness

Enter the duration of present depression illness, self-explanatory, enter per group and in weeks, if provided. Electronic version has default NG.

Side Effects Assessment

Determine if the side effects were assessed by entering Yes or No.

If side effects were assessed, the systematic method used to collect the data needs to be determined. More than one method can be entered.

Scale: Score and rate the severity of the adverse event.

Checklist: Authors list symptoms that are frequent.

Generic question: A simple general question or an open question.

Voluntary reporting: The subject provided the information by his/her own will (volunteered information); the assessor did not ask.

Unclear and not stated: Self-explanatory

Other: You will enter other only if patient was not systematically probed or did not volunteer information.

Intervention

Groups

This screen is very important. The different fields that you create will then trigger your pharmacotherapy data, psychotherapy, co-interventions, side effects and dropouts.

Group ID: In this field you enter group number.

Group Nickname: Enter name of medication or intervention. Be sure you spell correctly; enter only letter characters.

Check type of intervention for each group: newer antidepressant, (please enter in alphabetic order if you have two or more interventions that correspond to the same category); older antidepressant (please enter in alphabetic order if you have two or more interventions that correspond to the same category; and psychotherapy (enter a brief description). After all the different interventions have been checked and groups created, add an overall group: check "other" in the descriptor box and type "overall" in the drug name box. The overall group will be used for data and then presented for the overall participants, not by groups. Combination, check also the type of combination.

Augmentation medication: A drug regimen consisting of one or more agents, which are not themselves antidepressants, added to increase the efficacy of an antidepressant drug. An example would be to add pindolol to fluoxetine.

Associated symptoms drug: A medication given to treat associated depressive symptoms. Click to the appropriate tab (psychotherapy or pharmacotherapy) to describe further the intervention.

Pharmacotherapy

Please be sure you have the corresponding groups that you are getting data for. Enter data for all medications. Content of followup visit: This refers to what was done at each visit, whether assessment only (HAM D, MADRS, CGI, other), self help and or education material provided, titration of medication that was based on symptoms (this is in contrast to fixed dosing protocol), clinical visit with the provider, other and unclear.

Main Provider: In this section, enter who provided the intervention.

Total Planned visits: The number of visits that the subject had to have at the end of the study.

Frequency of Follow-up visits: You can use the drop list to choose how often the subjects had visits.

Psychotherapy

Be sure you are in the correct group.

Select the type of psychotherapy, social, format, provider, total planned visits and frequency of Follow-up. This is all done in the same manner as Pharmacotherapy was done.

Co-Interventions

Be sure you are in the corresponding group.

This section refers to the different kinds of co-interventions (unplanned interventions) that were given during the study period such as benzodiazepines, hypnotics, psychoterapy, adjuvant therapy (lithium, thyroid), etc. Enter the total number of subjects that received such co-intervention per group if provided. Note: If benzodiazepines were used for sedation, select hypnotic rather than benzodiazepine.

Participants

Treatment description: In this section describe each different intervention or treatment group in the study. The placebo group would always be the first intervention or treatment group; the following treatments would be entered by intensity, for example: placebo, drug, drug plus psychotherapy, psychotherapy.

Age range: Enter if provided. (Note: separate the minimum and maximum age by a coma) Example: range 65 to 75 you will enter 65,75).

Mean age: Enter if provided; please make pertinent calculations when necessary.

Male/female ratio: Enter appropriate numbers when provided, and make the necessary calculations when needed.

Ethnic groups: Enter number of subjects for each ethnic group when given.

Side effects

When starting to enter side effects data, you will have to enter in the first box the total number of subjects assessed. This will automatically set a default and enter this number in all the second boxes for each side effect.

Any side effects: On occasion, studies will describe all side effects as a total per group. In this case, enter the information in the field that states "any side effects."

Others will describe only side effects by system. Enter this information in the pertinent system field.

Some studies give information by a list of symptoms. Choose each symptom and enter the number of patients that had such symptom.

Note: Enter the number of patients that experience the side effect not the number of complaints.

Following is a list of symptoms that are also used and the different ways that they were coded:

  • Agitation = excitability
  • Fatigue = asthenia, lethargy
  • Lightheaded = dizziness
  • Nausea and vomiting = nausea
  • Somnolence = drowsiness
  • Paresthesia = other
  • Yawning = other
  • Tachycardia = cardiovascular
  • Vasodilatation = cardiovascular
  • Confusion = CNS
  • Decrease Attention = other

Dropouts

In this section, you should enter total number per group only. Also enter data for overall (you have previously created this group. Some studies do not provide dropout information per group, but provide only data as a total.

Dropout run-in: Enter total number of participants that drop out during run-in period. Not all studies have this data.

Total randomized: Enter total number of randomized participants. This is an important field that should not be left blank or missing.

Dropout side effects: Enter total number of participants who drop out of study due to adverse events, by group or as overall when not given by group.

Dropout failure, lack of effect, worsening symptoms: Enter total number of participants who drop out due to treatment failure, no efficacy, or stop due to worsening symptoms, etc.

Total dropouts: Enter total number of drop out per group (due to side effects, treatment failure, violation protocol, other, etc). Double-check that your math is correct. Sometimes the numbers do not add up, but you can backtrack.

When dropout tables combine dropouts due to side effects and lack of efficacy, count for both entities. For example, in the study that had a table as follows:

Drop outs due to:PlaceboFluoxetine
Lack of efficacy2120
Adverse Events88
Lack of
Efficacy and Adverse
Event
40
Other1110

You would enter:
  • Lack of efficacy: Placebo=25, Fluoxetine =20
  • Adverse Events: Placebo =12, Fluoxetine =9

Comparison Tables

If variance values were not given, please fill out group comparison Tables. If authors state no significance at a certain measurement point, after entering data be sure to request that we contact the author for more information. The comparison table will permit the user to enter additional statistical data that were used by the authors and will permit estimation of the variance for future quantitative analysis. Only collect comparison group data on HAM-D, MADRS, and CGI assessments even if said not statistically significant.

The first group and second group refer to the comparison example: 1 vs. 2, 1 vs. 3, 2 vs. 3.

  • Name:
  • In this field, you enter the group number.
  • Outcome:
  • Enter HAM D, MADRS, CGI. Remember these are the only assessments that we will compare.
  • Time:
  • Enter the time period of the assessment; enter number of weeks.
  • P value:
  • Enter the value for the two comparison groups.
  • Confidence:
  • Enter confidence interval for the two comparison groups.
  • Statistical test:
  • Enter type of statistical test such as ANOVA, t-test etc.
  • Observation:
  • Enter value
  • Degree:
  • Enter value of the degree of freedom, e.g. 6, 3, 1.
COMMENTS

Enter any pertinent comments in the different sections.

  • Design and Methods:
  • Diagnostic criteria:
  • Inclusion and Exclusion:
  • Intervention:
  • Co-interventions:
  • Participants:
  • Dropouts:
  • Side effects:
  • Outcomes:

Do investigators need to be contacted? Answer Yes or No if more information is needed.

Contact Message: Specify the type if information that is needed or the type of missing data that needs to be requested from authors.

Reference of Interest: Enter when you are reading the article and there is a reference that you need either to get more information of the study, (inclusion, demos etc.), or you see a reference of a study that you think that we need to abstract.

Outcomes

Group. Enter group number. Be sure your entering data for the corresponding group.

Outcome: Click the arrow on the right corner of the field to access a list of different depression scales (32) that are most frequently reported. Click on the one reported by the study. If functional status or social outcomes are reported, only abstract the following: SF-36, Social Assessment Scale Modified (SAS-M), Sickness Impact Profile (SIP), Endicott Quality of Life, Global Assessment Scale.

If the scale was not in the selection, click on "other." Tab to the following field and enter the name of the scale (for the EPC-Depression review, it is not necessary to complete the outcome data for "other" scales).

When entering data, don't collect data on sub-scales (e.g. HAM-A). Always enter data of total scale; the only exception is the SF-36 collect data on the mental sub-scale.

Number of items: Enter the number of items used in the different assessments, or any special assessment characteristic such as "Improve", "Patient assessment", "Severity", etc.

Outcome measured by: Choose from drop list:

  • Self administered: Participant answered on his/her own the assessment with no help from an interviewer.
  • Clinician rating scale: A physician did the assessment; this can be the primary care, or the psychiatrist.
  • Not described: self explanatory
  • Other: self explanatory

Time of Measurement: Enter the time period of the assessment using the number of weeks. This is a numeric value only.

Period and weeks: Choose from drop list; this measurement should always be in weeks.

  • Baseline: Measurement done at the beginning of the intervention.
  • Within treatment: This refers to different points that measurements were made between baseline and end of treatment.
  • End of treatment: measurement done at the end of intervention, end point.
  • Follow-up: measurement after the end of intervention. In some cases investigators will go back and try to assess subjects at 6 months after study ended.
  • Other: Please choose type of measure point, within, maintenance or follow up.
  • N: enter sample size per group.

Outcome reported: In this field enter how outcome was reported. Never assume that baseline data, followup data or end of treatment are measured, and reported the same way. Choose from drop list mean, mean change, etc. Blank field: This field is utilized in the following instances. If outcomes and results, are presented in a graphical format indicate that the data collected was "graphical", or if data was provided after contacting author or principal investigator indicate in this field that data was provided "by author".

Outcome Value: Enter value of the different outcome measurements.

Variance Reported as: Enter how variance was reported. Never assume that baseline data, follow up data or end of treatment are reported in same manner. Choose from drop list SD, SEM etc.

Other

Variance Other: If variance was provided after contacting author or principal investigator, indicate in this field that variance was provided "by author."

Variance Value: Enter the value of the different variance measurements.

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