Extraction form for project: Postpartum Care Up To One Year After Delivery

Design Details

1. Which KEY QUESTION(S) does this study address?
2. List other records that were extracted with this primary article
PMIDs or other identifiers (e.g., CN-01613374 or internal ID: 31123726)
3. What was the STUDY DESIGN?
4. RCTs only: What was the UNIT OF RANDOMIZATION of the study?
5. NRCSs only: What was the DIRECTIONALITY of the study?
6. What was the study's REGISTRATION NUMBER (e.g., ClinicalTrials.gov NCT number)?
Leave blank if not reported.
7. What was the STUDY NAME or ACRONYM (if any)?
Leave blank if not reported.
8. In what COUNTRY was the study conducted?
9. In what STATE(S) was the study conducted?'
Separate with commas
10. What were the START and END YEARS of the Study?
Leave blank if not reported.
Start yearEnd year
11. What were the FUNDING SOURCES for the study?
12. What were the participant INCLUSION criteria for the study?
13. What were the participant EXCLUSION criteria for the study?
14. If this study addresses KQ 1, what delivery strategies is the study ACTUALLY COMPARING?
Think carefully and select no more than a couple of options, preferably one.
15. Do you have any NOTES on the design of this study?
Leave blank if you don't.

Arms

Arm NameArm Description
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers

Arm Details

1. What was the NAME of the arm in the study?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
2. What was the SAMPLE SIZE at baseline?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
3. What was the CONTENT OF THE INTERVENTION(S) delivered?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
4. Delivery Strategy - WHERE was the intervention delivered?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
5. Delivery Strategy - HOW was the intervention delivered?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
6. Delivery Strategy - WHEN was the intervention delivered?
Examples: Frequency (e.g., 4 times, 6 times). Duration (e.g., 3 months, 6 months). Intensity (e.g., 0.5 hours per visit). Schedule (e.g., at 2 weeks, 6 weeks, and 12 weeks)
Home visits by doulas and hospital support for childbirth preparation and childbirth
Before giving birth
Around the time of giving birth
After hospital discharge
Case management by community case managers or social service providers
Before giving birth
Around the time of giving birth
After hospital discharge
7. Delivery Strategy - WHO delivered the intervention?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
8. Delivery Strategy - HEALTHCARE COORDINATION/MANAGED CARE
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
9. Delivery Strategy - INFORMATION/COMMUNICATION TECHNOLOGY
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
10. Delivery Strategy - INTERVENTIONS TARGETING HEALTH PROVIDERS
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
11. Delivery Strategy - Did the study involve any PERSONALIZATION/TITRATION/ADAPTATION of the delivery strategy?
Some of this may be in the Discussion section of the article.
Home visits by doulas and hospital support for childbirth preparation and childbirth
Before giving birth
Case management by community case managers or social service providers
Before giving birth
12. Delivery Strategy - Were there any UNPLANNED MODIFICATIONS to the delivery strategy?'
Some of this may be in the Discussion section of the article.
Home visits by doulas and hospital support for childbirth preparation and childbirth
Before giving birth
Case management by community case managers or social service providers
Before giving birth
13. Setting - What was the GEOGRAPHIC LOCATION of the study?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
14. Setting - What was the VOLUME of the FACILITY/HOSPITAL of the study?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
15. Setting - What was the TYPE of the FACILITY/HOSPITAL of the study?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
16. Setting - What was the FACILITY/HOSPITAL an ACADEMIC one?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
17. Setting - What was the LEVEL of the FACILITY/HOSPITAL of the study?
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers
18. Do you have any NOTES on the arms in this study?
Leave blank if you don't.
Home visits by doulas and hospital support for childbirth preparation and childbirth
Case management by community case managers or social service providers

Sample Characteristics

1. What was the SAMPLE SIZE AT BASELINE?
Baseline = at randomization (for RCTs) or at enrollment (for other study designs). Enter NR if not reported.
2. What was the AGE DISTRIBUTION of the participants in the study? (CONTINUOUS DATA)
Select and enter data for all that apply.
Mean
SD
SE
95% CI
Median
IQR
Range
NR
3. What was the AGE DISTRIBUTION of the participants in the study? (CATEGORICAL DATA)
Definition of categoryN%
Youngest category
2nd category
3rd category
4th category
5th category
6th category
7th category
NR
4. What was the BMI DISTRIBUTION of the participants in the study? (CONTINUOUS DATA)
Select and enter data for all that apply.
Mean
SD
SE
95% CI
Median
IQR
Range
When was the BMI measured?
NR
5. What was the BMI DISTRIBUTION of the participants in the study? (CATEGORICAL DATA)
Definition of categoryN%
Lowest BMI category
2nd category
3rd category
4th category
5th category
6th category
7th category
When was the BMI measured?
NR
6. What was the RACE DISTRIBUTION of the participants in the study?
N%
White (or Caucasian)
Black (or African)
Asian
Hispanic (or Latinx)
Other 1
Other 2
Other 3
NR
7. What was the SEXUAL/GENDER IDENTITY of the participants in the study?
Definition of categoryN%
1st category
2nd category
3rd category
4th category
NR
8. What was the EDUCATIONAL ATTAINMENT DISTRIBUTION of the participants in the study? (CONTINUOUS DATA)
Select and enter data for all that apply. Unit is years.
Mean
SD
SE
95% CI
Median
IQR
Range
NR
9. What was the EDUCATIONAL ATTAINMENT DISTRIBUTION of the participants in the study? (CATEGORICAL DATA)
Definition of categoryN%
1st category
2nd category
3rd category
4th category
5th category
NR
10. What was the EMPLOYMENT STATUS of the participants in the study?'
Definition of categoryN%
1st category
2nd category
3rd category
4th category
5th category
6th category
7th category
NR
11. What was the SOCIOECONOMIC STATUS of the participants in the study?
Definition of categoryN%
1st category
2nd category
3rd category
4th category
5th category
6th category
7th category
NR
12. What was the DISTRIBUTION of the FOLLOWING MISCELLANEOUS CHARACTERISTICS of the participants in the study?
Reported?DefinitionN%
Physical disabiliity
Immigrant
Refugee
Language discordance with provider
Irregular access to the internet
Lack of access to paid family leave
Medicaid
Supplemental Nutrition assistance Program (SNAP)
Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
13. What was the distribution of SUBSTANCE USE DISORDERS among participants in the study?
DefinitionN%
Alcohol use disorder
Tobacco use disorder
Opioid use disorder
Other substance use disorder 1
Other substance use disorder 2
Other substance use disorder 3
NR
14. What was the DISTRIBUTION of CARDIOVASCULAR DISORDERS among the participants in the study?
DefinitionN%
Hypertensive disorders of pregnancy
Hypertension
Gestational diabetes
Diabetes mellitus
Cardiovascular disorders
Other
NR
15. What was the DELIVERY CHARACTERISTICS of the participants in the study?
Reported?N%
Vaginal delivery
Cesarean delivery
Multiple births (e.g, twins, triplets)
Stillbirth
Spontaneous or induced abortion
16. What was the OFFSPRING CHARACTERISTICS of the participants in the study?
Reported?N%
Preterm birth
NICU admission
Neonatal death
Congenital anomalies
17. What ADDITIONAL sample characteristics did the study report that were NOT captured above?
Leave blank if none.
18. What SUBGROUP ANALYSES did the study report?
Leave blank if none.
19. Are there IMPORTANT DIFFERENCES in sample characteristics between the arms of the study?
20. Do you have any notes on the SAMPLE CHARACTERISTICS of this study?
Leave blank if you don't.

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalHealthcare Utilization: Unplanned care utilizationHospital readmission
  • All Participants
  • 3 (wk)
CategoricalClinical: Mental health symptomsDepressive symptoms (CESD ≥16)
  • All Participants
  • 3 (wk)
  • 3 (mo)
CategoricalClinical: Breastfeeding initiation/duration/exclusivityBreastfeeding initiation
  • All Participants
  • 3 (wk)
CategoricalClinical: Breastfeeding initiation/duration/exclusivityAny breastfeeding
  • All Participants
  • 3 (mo)

Outcome Details

1. Do you have any NOTES on the outcomes in this study?
Leave blank if you don't.
Healthcare Utilization: Unplanned care utilization
Clinical: Mental health symptoms
Clinical: Breastfeeding initiation/duration/exclusivity
Clinical: Breastfeeding initiation/duration/exclusivity

Risk of Bias - RCTs

1. 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.
Rating
Notes/Comments:
2. 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.
Rating
Notes/Comments:
3. Blinding of participants and personnel: 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 studding 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.
Rating
Notes/Comments:
4. 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.
Rating
Notes/Comments:
5. 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.
Rating
Notes/Comments:
6. 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.
Rating
Notes/Comments:
7. Intention-to-treat-analysis: Bias due to incomplete reporting and analysis according to group allocation
There is low risk of bias if all randomized patients were reported/analyzed in the group to which they were allocated by randomization.
Rating
Notes/Comments:
8. 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
Rating
Notes/Comments:
9. What was the OVERALL risk of bias for this study?

Risk of Bias Assessment - NRCS

1. 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.
Rating
Notes/Comments:
2. 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.
Rating
Notes/Comments:
3. 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.
Rating
Notes/Comments:
4. 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). If N/PN to 2.1: go to 2.4
Rating
Notes/Comments:
5. 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.
Rating
Notes/Comments:
6. 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?
Rating
Notes/Comments:
7. 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.
Rating
Notes/Comments:
8. 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”.
Rating
Notes/Comments:
9. Were STUDY PARTICIPANTS blinded?
Rating:
Notes/Comments:
10. Were STUDY PERSONNEL blinded?
Rating:
Notes/Comments:
11. Were OUTCOME ASSESSORS blinded?
Rating:
Notes/Comments:
12. Was there evidence of INCOMPLETE OUTCOME DATA?
In other words, this question is asking about the risk of ATTRITION BIAS.
Rating:
Notes/Comments:
13. Was there evidence of SELECTIVE OUTCOME REPORTING?
In other words, this question is asking about the risk of OUTCOME REPORTING BIAS.
Rating:
Notes/Comments:
14. Was there evidence suggesting OTHER BIAS?
There is a low risk of bias if the study appears to be free of other sources of bias not addressed elsewhere.
Rating:
Notes/Comments:
15. What was the OVERALL risk of bias for this study?

Results

Categorical


Healthcare Utilization: Unplanned care utilization (Hospital readmission)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
Home visits by doulas and hospital support for childbirth preparation and childbirth
vs.
Case management by community case managers or social service providers
3 (wk)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
Home visits by doulas and hospital support for childbirth preparation and childbirth
vs.
Case management by community case managers or social service providers

Clinical: Mental health symptoms (Depressive symptoms (CESD ≥16))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
vs.
3 (wk)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
p value
3 (mo)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
vs.

Clinical: Breastfeeding initiation/duration/exclusivity (Breastfeeding initiation)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
Home visits by doulas and hospital support for childbirth preparation and childbirth
vs.
Case management by community case managers or social service providers
3 (wk)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
Home visits by doulas and hospital support for childbirth preparation and childbirth
vs.
Case management by community case managers or social service providers

Clinical: Breastfeeding initiation/duration/exclusivity (Any breastfeeding)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
Home visits by doulas and hospital support for childbirth preparation and childbirth
vs.
Case management by community case managers or social service providers
3 (mo)
Total (N analyzed)
Odds Ratio, Adjusted (adjOR)
Events
95% CI low (adjOR)
Percentage
95% CI high (adjOR)
p value
Within Arm ComparisonsNet Comparisons
Home visits by doulas and hospital support for childbirth preparation and childbirthCase management by community case managers or social service providers
Home visits by doulas and hospital support for childbirth preparation and childbirth
vs.
Case management by community case managers or social service providers