Extraction form for project: Management of Primary Headache During Pregnancy

Arms

N/A

Arm Details

1. Provide a BRIEF DESCRIPTION of the intervention.
Skip if the rest of the questions answer this, e.g., for a specific drug name. If multiple pharm/non-pharm interventions, enter then just list them.
2. What was the DOSE of the drug?
Include amount (number) and unit, with a space between them. Skip if not applicable. Enter "NR" if not reported.
3. What was the ROUTE of the drug?
If there was a change in route mid-course, enter all applicable routes and also explain using the "Other" option. Skip if not applicable.
4. What was the FREQUENCY of the intervention?
Enter number per time period, e.g., 3/day. For single dose/time interventions, enter "Once". Enter "NR" if not reported.
5. What was the DURATION of the intervention?
Include number and unit, with a space between them.
6. Do you have any NOTES regarding the arms in this study?
Leave blank if you don't.

Outcomes

N/A

Design

1. Which KEY QUESTION (KQ) does this study address?
Select all that apply.
2. What is the STUDY DESIGN?
3. What was the ANALYTIC METHOD used to control for differences between study groups?
Select all that apply.
4. What was the DIRECTIONALITY of the study?
5. Does the study have a CLINICALTRIALS.GOV IDENTIFICATION NUMBER?
6. In what COUNTRY was the study done?
Select all that apply.
7. What was the FUNDING SOURCE of the study?
Select all that apply.
8. Does the study have a NAME or ACRONYM?
9. What were the START and END YEARS of the study?
Years (not months). If either is not reported, enter "NR" in the appropriate cell(s).
Start yearEnd year
Years
10. What were the study INCLUSION criteria?
Keep succinct. Use common abbreviations. Omit criteria of minor relevance (e.g., language, consent). Enter "NR" if not reported.
11. What were the study EXCLUSION criteria?
Keep succinct. Use common abbreviations. Omit criteria of minor relevance (e.g., language, consent). Enter "NR" if not reported.
12. Do you have any NOTES regarding the design or any overall aspects of this study?
Leave blank if you don't.
13. How many DATABASES did the authors search?
14. What was the YEAR of the last search?
15. How many STUDIES were included in the review?
16. What INTERVENTIONS were addressed?
ClassIntervention
Intervention 1
Intervention 2
Intervention 3
Intervention 4
Intervention 5
17. Were MATERNAL adverse events reported?
18. Were FETAL/CHILD adverse events reported?
19. AMSTAR Item 1 - Did the authors specify the research questions and inclusion criteria for the SR?
20. AMSTAR Item 4 - Did the SR authors use a comprehensive literature search strategy?
21. AMSTAR Item 5 - Did the SR authors perform study selection in duplicate?
22. AMSTAR Item 6 - Did the SR authors perform data extraction in duplicate, either independently or through verification?
23. AMSTAR Item 8 - Did the SR authors describe the included studies in adequate detail?
24. AMSTAR Item 9 - Did the SR authors use a satisfactory technique for assessing the risk of bias in individual studies that were included in the SR?
25. AMSTAR Item 12 - Did the SR authors assess the potential impact of risk of bias in individual studies on the summary results, interpretation, discussion?
26. AMSTAR Item 11 - If meta-analysis (MA) was performed did the SR authors use appropriate methods for statistical combination of results?
27. AMSTAR Item 14 - Did the SR authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the SR?
28. AMSTAR Item 16 - Did the SR authors report the lack of significant potential of conflict of interest (COI) regarding conducting the SR?
29. What was the OVERALL QUALITY OF THE SYSTEMATIC REVIEW
30. MATERNAL Adverse Events - ANTEPARTUM
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Adverse effect, Any
Antepartum hemorrhage
Eclampsia
Hospitalization during pregnancy
Placental abruption
Pregnancy-induced hypertension
Thrombosis
31. MATERNAL Adverse Events - DELIVERY
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Cesarean section
Induction of labor
Induction of labor or cesarean section
Length of labor
32. MATERNAL Adverse Events - POSTPARTUM
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Postpartum diastolic blood pressure
Postpartum hemorrhage
Postpartum hypertension
Postpartum mean arterial pressure
Postpartum systolic blood pressure
33. MATERNAL Adverse Events - TIMING NOT REPORTED
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Adverse effects, Any
Absent or reduced tendon reflexes
Blurred vision
Cardiac arrest
Death
Diastolic blood pressure
Discontinuation due to adverse effects
Dizziness
Drowsiness or confusion
Flushing and/or warmth
Gastrointestinal symptoms
Headache
Hospitalizations
Hypotension
Itching and/or tingling
Muscle weakness
Nausea and/or vomiting
Pulmonary edema
Respiratory arrest
Respiratory depression/other respiratory problems
Slurred speech
Sweating
Systolic blood pressure
Tachycardia
Thirst or mouth dryness
34. FETAL/CHILD Adverse Events - IN UTERO
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Fetal death or spontaneous abortion
Fetal growth restriction
Fetal intracranial hemorrhage
Fetal or neonatal death, including spontaneous abortion
Spontaneous abortion
Spontaneous abortion or stillbirth
35. FETAL/CHILD Adverse Events - PERINATAL
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Birth weight
Gestational age at birth
Large for gestational age
Low birth weight
Perinatal death
Preterm birth
Small for gestational age
Stillbirth
36. FETAL/CHILD Adverse Events - NEONATAL
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Adverse effects, Any
Bronchopulmonary dysplasia
IGNORE
Congenital anomalies, All or major
Congenital anomalies, Any
Congenital anomalies, Atrial septum defect
Congenital anomalies, Cardiovascular
Congenital anomalies, Cleft lip
Congenital anomalies, Cleft lip or palate
Congenital anomalies, Cleft palate
Congenital anomalies, Club foot
Congenital anomalies, Diaphragmatic hernia
Congenital anomalies, Genitourinary
Congenital anomalies, Hypoplastic left heart
Congenital anomalies, Hypospadias
Congenital anomalies, Major
Congenital anomalies, Minor
Congenital anomalies, Neural tube defects
Congenital anomalies, Oral cleft
Congenital anomalies, Orofacial clefts
Congenital anomalies, Respiratory system anomalies
Congenital anomalies, Severe hypospadias
Congenital anomalies, Skeletal or limb defects
Congenital anomalies, Ventricular septum defect
Hospitalization
Inguinal hernia
Intraventricular hemorrhage
Intraventricular hemorrhage: Grade III-IV
Necrotizing enterocolitis
Neonatal bradycardia
Neonatal convulsions
Neonatal hypoglycemia
Neonatal jaundice
Neonatal mortality
Neonatal pulmonary edema
Neonatal respiratory distress
Neonatal withdrawal symptoms
NICU admission
Other neonatal bleed
Patent ductos arteriosus
Periventricular leukomalacia
Respiratory distress syndrome
Sepsis
Undescended testes
37. FETAL/CHILD Adverse Events - CHILD
N StudiesEffect MeasureEffect Size95% CI LL95% CI ULConclusion
Attention deficit hyperactivity disorder
Autism spectrum disorder
Autism/dyspraxia
IGNORE
Behavior problems (at 18 months)
Child hospitalization (at 12 months)
Child hospitalization (at 18 months)
Cognitive developmental delay
Conduct disorder
Developmental outcomes
Hearing problems
Hyperactivity symptoms
Inability to sit without support at 6 months
Infant death (after discharge)
Language delay
Language problems, Undefined
Malformations (at 18 months)
Motor or speech delays
Poor fine motor function
Poor gross motor function
Poor growth (at 18 months)
Poor language comprehension
Poor language expression
Psychomotor developmental delay
Respiratory problems
Sight problems

Outcome Details

N/A

Baselines

1. What was the SAMPLE SIZE at baseline?
2. What were the RACE/ETHNICITY of the women in the study?
Select and enter data for all that apply. Percentages only (not proportions).
3. What was the AGE DISTRIBUTION of the women in the study? (CONTINUOUS data)
Select and enter data for all that apply. Categorical age data are in the next question.
4. What was the AGE DISTRIBUTION of the women in the study? (CATEGORICAL data)
Define the categories and then report % in each category. Skip question if categorical age data are not reported.
Definition of category%
Youngest category
2nd category
3rd category
4th category
5th category
6th category
7th category
5. In what PHASE were the women in the study?
Select and enter data for all that apply. Percentages only (not proportions).
6. What was the GESTATIONAL AGE DISTRIBUTION of the women in the study? (CONTINUOUS data)
Select and enter data for all that apply.
7. What was the UNIT for the gestational age you answered in the previous question?
Leave blank if gestational age was not reported.
8. What was the GRAVIDITY DISTRIBUTION of the women in the study? (CONTINUOUS data)
Gravidity refers to the total number of times that a woman has been pregnant, irrespective of the outcome. Select and enter data for all that apply.
9. What was the PARITY DISTRIBUTION of the women in the study? (CONTINUOUS data)
Parity refers to the total number of births that a woman has had after 20 weeks gestation. Select and enter data for all that apply.
10. What were the TYPES of PRIMARY HEADACHE in the women in the study?
Select and enter data for all that apply. Percentages only (not proportions).
11. What percentage of the women in the study had a HISTORY OF PRIMARY HEADACHE?
Select and enter data for all that apply. Percentages only (not proportions).
12. Do you have any NOTES regarding the baseline characteristics in this study?
Skip if you don't.

Results

N/A

Quality

1. Q1: ROBINS-I 1.1 Is there potential for confounding of the effect of intervention in this study?
In rare situations, such as when studying harms that are very unlikely to be related to factors that influence treatment decisions, no confounding is expected and the study can be considered to be at low risk of bias due to confounding, equivalent to a fully randomized trial. There is no NI (No information) option for this signalling question.<br /><span style='color: red;'>If N/PN to 1.1: the study can be considered to be at low risk of bias due to confounding and no further signalling questions need be considered. If Y/PY to 1.1: determine whether there is a need to assess time-varying confounding:</span>
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2. Q2: Did the study divide the follow up time of each individual participant into the different interventions?
If Yes, don't answer the rest of the questions for confounding. You can skip to Question 2.1.
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3. Q3: ROBINS-I 1.4. Did the authors use an appropriate analysis method that controlled for all the important confounding domains?
Appropriate methods to control for measured confounders include stratification, regression, matching, standardization, and inverse probability weighting. They may control for individual variables or for the estimated propensity score. Inverse probability weighting is based on a function of the propensity score. Each method depends on the assumption that there is no unmeasured or residual confounding.
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4. 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?
Appropriate control of confounding requires that the variables adjusted for are valid and reliable measures of the confounding domains. For some topics, a list of valid and reliable measures of confounding domains will be specified in the review protocol but for others such a list may not be available. Study authors may cite references to support the use of a particular measure. If authors control for confounding variables with no indication of their validity or reliability pay attention to the subjectivity of the measure. Subjective measures (e.g. based on self-report) may have lower validity and reliability than objective measures such as lab findings.
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5. Q5: ROBINS-I 1.6. Did the authors control for any post-intervention variables that could have been affected by the intervention?
Controlling for post-intervention variables that are affected by intervention is not appropriate. Controlling for mediating variables estimates the direct effect of intervention and may introduce bias. Controlling for common effects of intervention and outcome introduces bias.
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6. Q6: Risk of bias judgement for BIAS DUE TO CONFOUNDING
See Table 1 in the ROBINS-I Tool - Table 1, pages 15 and 16 at the following link: https://sites.google.com/site/riskofbiastool/welcome/home/current-version-of-robins-i/robins-i-tool-2016?authuser=0
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7. 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?
This domain is concerned only with selection into the study based on participant characteristics observed after the start of intervention. Selection based on characteristics observed before the start of intervention can be addressed by controlling for imbalances between experimental intervention and comparator groups in baseline characteristics that are prognostic for the outcome (baseline confounding).<br /><span style='color: red;'>If N/PN to 2.1: go to 2.4</span>
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8. 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?
Selection bias occurs when selection is related to an effect of either intervention or a cause of intervention and an effect of either the outcome or a cause of the outcome. Therefore, the result is at risk of selection bias if selection into the study is related to both the intervention and the outcome.
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9. 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?
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10. Q10: ROBINS-I 2.4. Do start of follow-up and start of intervention coincide for most participants?
If participants are not followed from the start of the intervention then a period of follow up has been excluded, and individuals who experienced the outcome soon after intervention will be missing from analyses. This problem may occur when prevalent, rather than new (incident), users of the intervention are included in analyses.
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11. Q11: Did the start and follow up calendar years coincide for most participants in the study?
This question is about calendar years.
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12. 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?
It is in principle possible to correct for selection biases, for example by using inverse probability weights to create a pseudo-population in which the selection bias has been removed, or by modelling the distributions of the missing participants or follow up times and outcome events and including them using missing data methodology. However such methods are rarely used and the answer to this question will usually be ‘No’.
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13. Q13: ROBINS-I - Risk of bias judgement for BIAS IN SELECTION OF PARTICIPANTS INTO THE STUDY
See Table 1 in the ROBINS-I Tool
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14. Q14: Cochrane - Random sequence generation (selection bias): Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence
There is a low risk of selection bias if the investigators describe a random component in the sequence generation process such as: referring to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). There is a high risk of selection bias if the investigators describe a non-random component in the sequence generation process, such as: sequence generated by odd or even date of birth, date (or day) of admission, hospital or clinic record number; or allocation by judgement of the clinician, preference of the participant, results of a laboratory test or a series of tests, or availability of the intervention.
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15. Q15: Cochrane - Allocation concealment (selection bias): Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
There is a low risk of selection bias if the participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomization); sequentially numbered drug containers of identical appearance; or sequentially numbered, opaque, sealed envelopes. There is a high risk of bias if participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; or other explicitly unconcealed procedures.
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16. Q16: Cochrane - Blinding of participants (performance bias): Performance bias due to knowledge of the allocated interventions by participants during the study
There is a low risk of performance bias if blinding of participants and key study personnel was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.
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17. 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.
There is a low risk of performance bias if blinding of personnel was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.
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18. Q18: Cochrane - FOR OBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
There is low risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.; or: >> for patient-reported outcomes in which the patient was the outcome assessor (e.g., pain, disability): there is a low risk of bias for outcome assessors if there is a low risk of bias for participant blinding. >> for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers (e.g., co-interventions, length of hospitalization, treatment failure), in which the care provider is the outcome assessor: there is a low risk of bias for outcome assessors if there is a low risk of bias for care providers. >> for outcome criteria that are assessed from data from medical forms: there is a low risk of bias if the treatment or adverse effects of the treatment could not be noticed in the extracted data.
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19. Q19: Cochrane - FOR SUBJECTIVE OUTCOMES - Blinding of outcome assessor (detection bias): Detection bias due to knowledge of the allocated interventions by outcome assessors.
There is low risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken; or if there was no blinding or incomplete blinding, but the review authors judge that the outcome is not likely to be influenced by lack of blinding.; or: >> for patient-reported outcomes in which the patient was the outcome assessor (e.g., pain, disability): there is a low risk of bias for outcome assessors if there is a low risk of bias for participant blinding. >> for outcome criteria that are clinical or therapeutic events that will be determined by the interaction between patients and care providers (e.g., co-interventions, length of hospitalization, treatment failure), in which the care provider is the outcome assessor: there is a low risk of bias for outcome assessors if there is a low risk of bias for care providers. >> for outcome criteria that are assessed from data from medical forms: there is a low risk of bias if the treatment or adverse effects of the treatment could not be noticed in the extracted data.
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20. Q21: Cochrane - Selective Reporting (reporting bias): Reporting bias due to selective outcome reporting
There is low risk of reporting bias if the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way, or if the study protocol is not available but it is clear that the published reports include all expected outcome, including those that were pre-specified (convincing text of this nature may be uncommon). There is a high risk of reporting bias if not all of the study’s pre-specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified; one or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study.
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21. Q20: Cochrane - Incomplete outcome data (attrition bias): Attrition bias due to amount, nature or handling of incomplete outcome data
There is a low risk of attrition bias if there were no missing outcome data; reasons for missing outcome data were unlikely to be related to the true outcome (for survival data, censoring unlikely to be introducing bias); missing outcome data were balanced in numbers, with similar reasons for missing data across groups (The percentage of withdrawals and drop-outs should not exceed 20% for short-term follow-up and 30% for long-term follow-up and should not lead to substantial bias. Note: these percentages are commonly used but arbitrary, not supported by the literature); missing data were imputed using appropriate methods. For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk was not enough to have a clinically relevant impact on the intervention effect estimate. For continuous outcome data, the plausible effect size (difference in means or standardized difference in means) among missing outcomes were not enough to have a clinically relevant impact on observed effect size. Note: if drop-outs are very large, imputation using even ‘acceptable’ methods may still suggest a high risk of bias.
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22. Q22: Cochrane - Other Bias: Bias due to problems not covered elsewhere in the table. If yes, describe them in the Notes.
There is a low risk of bias if the study appears to be free of other sources of bias not addressed elsewhere.
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23. Q23: NHLBI - Were eligibility/selection criteria for the study population prespecified and clearly described?
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24. Q24: NHLBI - Was the test/service/intervention clearly described and delivered consistently across the study population?
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25. Q25: NHLBI - Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
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26. Adjust Quality Rating (for Key Questions: 1, 2)
Quality Guideline Used:
Select Current Overall Rating:
Notes on this Rating:
27. Adjust Quality Rating (for Key Questions: 3, 4)
Quality Guideline Used:
Select Current Overall Rating:
Notes on this Rating: