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Extraction form for Direct Evidence (Primary Studies)


Arm Name Suggestions

Arm Title Arm Description User Note
Relaxation training, biofeedback, and physical therapy exercises combination
Education and thermal biofeedback combination
Metoclopramide and Diphendryamine combination
Codeine
Acupuncture
Conventional treatment
Sumatriptan during pregnancy
No triptan during pregnancy
No triptan before or during pregnancy
Triptan during pregnancy
Sumatriptan
Triptan before pregnancy only
Triptan
Naratriptan
Sumatriptan and Naproxen Sodium combination
Other drug treatment
Sumatriptan or Ergotamine
Topiramate
Sumatriptan or Naratriptan
Peripheral nerve blocks
Relaxation training, biofeedback, and psychotherapy combination
Antimigraine drugs
Sumatriptan or Ergotamine before pregnancy only

Arm Details

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Design Details and Enrollment

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Row Headers
Start year
End year
Years
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Question 12

Baseline Characteristics Fields

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Row Headers
Definition of category
%
Youngest category
2nd category
3rd category
4th category
5th category
6th category
7th category
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Question 12

Outcome Name Suggestions

Outcome Title Note
Acute headache attacks - Occurrence
Acute headache attacks - Frequency
Acute headache attacks - Severity
Acute headache attacks - Duration
Headache-related symptoms - Occurrence
Headache-related symptoms - Frequency
Headache-related symptoms - Severity
Headache-related symptoms - Duration
Headache-related symptoms - Most bothersome symptom
Emergency department visits
Clinic visits
Hospitalizations
Quality of life
Functional outcomes - Impact on family life
Functional outcomes - Employment/school attendance
Functional outcomes - Time spent managing disease
Resource use
Acceptability of intervention by patients
Patient satisfaction with intervention
Number of prescribed medications
Number of days with acute medication use
Acute headache attacks - Resolution
Headache-related symptoms - Resolution
Adverse events - Maternal - Serious
Adverse events - Maternal - Cardiovascular
Adverse events - Maternal - "Non-serious"
Adverse events - Maternal - Nonobstetrical
Adverse events - Maternal - Cesarean section
Adverse events - Maternal - Reduced breast milk production
Adverse events - Maternal - Symptoms related to withdrawal of intervention or study participation
Adverse events - Maternal - Discontinuation due to adverse events
Adverse events - Fetal/Infant - "Serious"
Adverse events - Fetal/Infant - Death, spontaneous abortion, stillbirth, infant death
Adverse events - Fetal/Infant - Preterm birth
Adverse events - Fetal/Infant - Low birth weight for gestational age
Adverse events - Fetal/Infant - Congenital anomalies or other newborn abnormalities
Adverse events - Fetal/Infant - Perinatal complications
Adverse events - Fetal/Infant - Neurodevelopmental
Adverse events - Fetal/Infant - "Non-serious"
Adverse events - Fetal/infant - Breastfeeding delay, cessation, reduced frequency, reduced volume
Adverse events - Fetal/infant - Poor infant attachment/bonding
Adverse events - Fetal/infant - Symptoms related to withdrawal of medication
Adverse events - Fetal/Infant - Symptoms related to withdrawal of intervention or study participation
Adverse events - Maternal - Any
Adverse events - Fetal/Infant - Any
Need for additional medications
Adverse events - Fetal/Infant - Low birth weight
Adverse events - Fetal/Infant - Behavioral/Social
Adverse events - Maternal - Other
Adverse events - Maternal - Elective or induced abortion
Medication use
Adverse events - Fetal/Infant - Other


Outcome Details

No questions specified.

Quality Dimension Fields

Quality Dimension Value Notes
Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
Q2: Did the study divide the follow up time of each individual participant into the different interventions?
Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
Q4: ROBINS-I 1.5. If Y/PY to 1.4: Were confounding domains that were controlled for measured validly and reliably by the variables available in this study?
Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING
Q7: ROBINS-I 2.1. Was selection of participants into the study (or into the analysis) based on participant characteristics observed after the start of intervention?
Q8: ROBINS-I 2.2. If Y/PY to 2.1: Were the post-intervention variables that influenced selection likely to be associated with intervention?
Q9: ROBINS-I 2.3 If Y/PY to 2.2: Were the post-intervention variables that influenced selection likely to be influenced by the outcome or a cause of the outcome?
Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
Q11: Did the start and follow up calendar years coincide for most participants in the study?
Q12: ROBINS-I 2.5. If Y/PY to 2.2 and 2.3, or N/PN to 2.4: Were adjustment techniques used that are likely to correct for the presence of selection biases?
Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence
Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study
Q17: Cochrane - Blinding of personnel/ care providers (performance bias): Performance bias due to knowledge of the allocated interventions by personnel/care providers during the study.
Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data
Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.
Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?

Overall Rating of Study:
Quality Guideline Used in Assessment: