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Gray RN, McCrory DC, Eberlein K, et al. Self-Administered Drug Treatments for Acute Migraine Headache. Rockville (MD): Agency for Health Care Policy and Research (US); 1999 Feb. (Technical Reviews, No. 2.4.)

Cover of Self-Administered Drug Treatments for Acute Migraine Headache

Self-Administered Drug Treatments for Acute Migraine Headache.

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Appendix BData collection form

Data Abstraction Form

ver 5.19.95

Reviewer

First Author (last name): __________

Pro-Cite no.: _______

Todays date: ___/____/___

EXCLUDE Why?

Are most or all of the patients in this study in the pediatric age group (0–17)? No Yes ->STOP

State the inclusion criteria (headache diagnoses first)

Headache diagnosis: Migraine Tension-type Cluster mixed

other________

Diagnostic criteria: IHS Ad hoc other none/NS

State the exclusion criteria (headache diagnoses first)

Patient enrollment site (circle all that apply)

Primary Care Clinic General Neurology Clinic Headache Clinic Not Stated

Emergency Clinic Pain Clinic Psychology clinic Other____________

Design:

Unclear

Single-period parallel-group

Crossover

Matched pair (or paired)

For Cross-over design only-> Was there a significant carry-over effect? Yes No Not Stated

If “yes” then abstract “period one” data only as if the trial used a parallel group design.

Instrument to measure bias in pain research reports (Jadad)ResponseScore
1Was the study described as randomized (this includes the use of words such as randomly, random and randomization)?Yes
No
1
0
laIf the method of generating the randomization sequence was described, was it adequate (table of random numbers, computer-generated, coin tossing, etc.) or inadequate (alternating, date of birth, hospital number, etc.)?Not described/NA
Adequate
Inadequate
0
1
−1
2Was the study described as double-blind?Yes
No
1
0
2aIf the method of blinding was described, was it adequate (identical placebo, active placebo, etc.) or inadequate (comparison of tablet vs. injection with no double dummy)?Not described/NA
Adequate
Inadequate
0
1
−1
3Was there a description of withdrawals and drop-outs?Yes
No
1
0
Describe the elements of the study design common to all groups (eg, 4 wk lead in, 12 wk treatment period)
Brief description of interventionDetails (including dose, duration, timing, etc.)
Intervention 1 (placebo or control or wait-list)
Intervention 2
Intervention 3
Intervention 4

Patient characteristics (overall: if figures are given by treatment groups, then calculate weighted average)

Age _______±_______ or ______(__ to __)

mean ± std dev median and (lower to upper range)

Female (%)_________

Chronicity of H/A d/o ([x with macron],years)__________

HA frequency (#HA/mo)__________

Patient characteristics describe: pre-treatment (trial entry) post-treatment (completion)

Adverse Event Frequency (%)OverallIntervention 1Intervention 2Intervention 3Intervention 4
Total entered study, n
Total completed study, n
Dropouts 2° S/E, (%)
Dropouts, total, (%)
Outcome measure Primary or secondaryDef’n (e.g. from 2 or 3 to 0 or 1)How measured? (e.g. 4 pt scale)When assessed? (2 hrs, 2 mo)When were sx recorded? (daily, etc)
BEFORE/Period 1/single-period parallel-group designGp 1Gp 2Gp 3Gp 4
Sample size
Mean
SD/VAR/SEM (circle one)
AFTER/Period 2
Sample size
Mean
SD/VAR/SEM (circle one)
BEFORE/AFTER comparisons
Mean
SD/VAR/SEM of difference (circle one)
Test statistic for diff
Degrees of freedom for test statistic
p-value of test statistic
Name of test statistic (e.g.; t, F, etc.)
BETWEEN GROUP COMPARISONS
Mean
SD/VAR/SEM of difference (circle one)
Test statistic for diff
Degrees of freedom for test statistic
p-value of test statistic
Name of test statistic (e.g.; t, F, etc.)
F statisticd.f.p-value
OVERALL COMPARISON/ANOVA
Outcome measure Primary or secondaryDef’n (e.g. from 2 or 3 to 0 or 1)How measured? (e.g. 4 pt scale)When assessed? (2 hrs, 2 mo)When were sx recorded? (daily, etc)
Outcomes (fill in dichotomous outcomes, categories, or ranges for groups as column headers)Totals
worstbest
TreatmentsN (%)N (%)N (%)N (%)N (%)N (100%)
A
B
C
D
Outcome measure Primary or secondaryDef’n (e.g. from 2 or 3 to 0 or 1)How measured? (e.g. 4 pt scale)When assessed? (2 hrs, 2 mo)When were sx recorded? (daily, etc)
worstbestTotals
TreatmentsN(%)N(%)N(%)N(%)N(%)N (100%)
A
B
C
D
Bookshelf ID: NBK45468
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