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

Design Details

1. Which KEY QUESTION(S) does this study address?
Multiple Choice
Key Question 1 - Delivery strategies
Key Question 2 - Extension of health insurance coverage or improved access to care
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?
Single Choice
Randomized controlled trial (RCT)
Nonrandomized comparative study (NRCS)
Case-control study
Other, specify:
4. RCTs only: What was the UNIT OF RANDOMIZATION of the study?
Dependency
  • Question Position: 3
    • - Option: Randomized controlled trial (RCT)
    Single Choice
    Individual (participant level)
    Cluster (group level, e.g., clinic, hospital)
    Unclear
    5. NRCSs only: What was the DIRECTIONALITY of the study?
    Dependency
  • Question Position: 3
    • - Option: Nonrandomized comparative study (NRCS)
    Single Choice
    Prospective
    Retrospective
    Unclear
    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?
    Multiple Choice
    US
    Canada
    Other high income country/countries, specify:
    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?
    Multiple Choice
    Industry, specify:
    Non-industry, specify:
    Explicitly stated the study was not funded
    NR
    12. What were the participant INCLUSION criteria for the study?
    Multiple Choice
    Age, specify:
    Gestational age, specify:
    Overall/general postpartum/pregnant population, specify:
    At-risk postpartum/pregnant population due to social determinants, specify:
    At-risk postpartum/pregnant population due to health reasons, specify:
    Other, specify:
    NR
    13. What were the participant EXCLUSION criteria for the study?
    Single Choice
    Specified:
    NR
    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.
    Multiple Choice
    WHERE healthcare is delivered
    HOW healthcare is delivered
    WHEN healthcare is delivered
    WHO delivers healthcare/support
    Healthcare COORDINATION/MANAGEMENT
    INFORMATION/COMMUNICATION Technology
    Interventions targeted at healthcare providers or systems
    15. Do you have any NOTES on the design of this study?
    Leave blank if you don't.

    Arm Details

    1. What was the NAME of the arm in the study?
    2. What was the SAMPLE SIZE at baseline?
    3. What was the CONTENT OF THE INTERVENTION(S) delivered?
    4. Delivery Strategy - WHERE was the intervention delivered?
    5. Delivery Strategy - HOW was the intervention delivered?
    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)
    7. Delivery Strategy - WHO delivered the intervention?
    8. Delivery Strategy - HEALTHCARE COORDINATION/MANAGED CARE
    9. Delivery Strategy - INFORMATION/COMMUNICATION TECHNOLOGY
    10. Delivery Strategy - INTERVENTIONS TARGETING HEALTH 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.
    12. Delivery Strategy - Were there any UNPLANNED MODIFICATIONS to the delivery strategy?'
    Some of this may be in the Discussion section of the article.
    13. Setting - What was the GEOGRAPHIC LOCATION of the study?
    14. Setting - What was the VOLUME of the FACILITY/HOSPITAL of the study?
    15. Setting - What was the TYPE of the FACILITY/HOSPITAL of the study?
    16. Setting - What was the FACILITY/HOSPITAL an ACADEMIC one?
    17. Setting - What was the LEVEL of the FACILITY/HOSPITAL of the study?
    18. Do you have any NOTES on the arms in this study?
    Leave blank if you don't.

    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
    Single Choice

    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
    Multiple Choice

    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?
    Multiple Choice
    Antepartum, specify:
    Peripartum
    Postpartum, specify:
    NR
    Multiple Choice

    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?
    Single Choice
    Antepartum, specify:
    Peripartum
    Postpartum, specify:
    NR
    Multiple Choice

    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
    Multiple Choice

    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
    Multiple Choice

    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
    Multiple Choice

    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
    Multiple Choice

    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
    Multiple Choice

    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
    Multiple Choice

    12. What was the DISTRIBUTION of the FOLLOWING MISCELLANEOUS CHARACTERISTICS of the participants in the study?
    Reported?DefinitionN%
    Physical disabiliity
    Multiple Choice
    NR
    Immigrant
    Multiple Choice
    NR
    Refugee
    Multiple Choice
    NR
    Language discordance with provider
    Multiple Choice
    NR
    Irregular access to the internet
    Multiple Choice
    NR
    Lack of access to paid family leave
    Multiple Choice
    NR
    Medicaid
    Multiple Choice
    NR
    Supplemental Nutrition assistance Program (SNAP)
    Multiple Choice
    NR
    Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
    Multiple Choice
    NR
    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
    Multiple Choice

    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
    Multiple Choice

    15. What was the DELIVERY CHARACTERISTICS of the participants in the study?
    Reported?N%
    Vaginal delivery
    Multiple Choice
    NR
    Cesarean delivery
    Multiple Choice
    NR
    Multiple births (e.g, twins, triplets)
    Multiple Choice
    NR
    Stillbirth
    Multiple Choice
    NR
    Spontaneous or induced abortion
    Multiple Choice
    NR
    16. What was the OFFSPRING CHARACTERISTICS of the participants in the study?
    Reported?N%
    Preterm birth
    Multiple Choice
    NR
    NICU admission
    Multiple Choice
    NR
    Neonatal death
    Multiple Choice
    NR
    Congenital anomalies
    Multiple Choice
    NR
    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?
    Single Choice
    No
    Yes, specify variables:
    Unclear
    20. Do you have any notes on the SAMPLE CHARACTERISTICS of this study?
    Leave blank if you don't.

    Outcome Details

    1. Do you have any NOTES on the outcomes in this study?
    Leave blank if you don't.
    Healthcare Utilization: Attendance at PP visits :

    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    Unclear
    High
    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
    Single Choice
    Low
    High
    Notes/Comments:
    9. What was the OVERALL risk of bias for this study?
    Single Choice
    Low
    Moderate
    High

    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
    Single Choice
    Y
    PY
    PN
    N
    NI
    NA
    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.
    Dependency
  • Question Position: 1
    • - Cell: (Rating x )
    • - Option: Y
    • - Cell: (Rating x )
    • - Option: PY
    Rating
    Single Choice
    Y
    PY
    PN
    N
    NI
    NA
    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
    Single Choice
    Y
    PY
    PN
    N
    NI
    NA
    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
    Single Choice
    Y
    PY
    PN
    N
    NI
    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.
    Dependency
  • Question Position: 4
    • - Cell: (Rating x )
    • - Option: Y
    • - Cell: (Rating x )
    • - Option: PY
    Rating
    Single Choice
    Y
    PY
    PN
    N
    NI
    NA
    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?
    Dependency
  • Question Position: 5
    • - Cell: (Rating x )
    • - Option: Y
    • - Cell: (Rating x )
    • - Option: PY
    Rating
    Single Choice
    Y
    PY
    PN
    N
    NI
    NA
    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
    Single Choice
    Y
    PY
    PN
    N
    NI
    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
    Single Choice
    NA
    Y
    PY
    PN
    N
    NI
    Notes/Comments:
    9. Were STUDY PARTICIPANTS blinded?
    Rating:
    Single Choice
    Low
    Unclear
    High
    Notes/Comments:
    10. Were STUDY PERSONNEL blinded?
    Rating:
    Single Choice
    Low
    Unclear
    High
    Notes/Comments:
    11. Were OUTCOME ASSESSORS blinded?
    Rating:
    Single Choice
    Low
    Unclear
    High
    Notes/Comments:
    12. Was there evidence of INCOMPLETE OUTCOME DATA?
    In other words, this question is asking about the risk of ATTRITION BIAS.
    Rating:
    Single Choice
    Low
    Unclear
    High
    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:
    Single Choice
    Low
    Unclear
    High
    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:
    Single Choice
    Low
    Unclear
    High
    Notes/Comments:
    15. What was the OVERALL risk of bias for this study?
    Single Choice
    Low
    Moderate
    High

    Suggested Arms

    NameDescription
    Total All arms combined

    Please see downloadable data for more

    Suggested Outcomes

    TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)
    CategoricalClinical: Breastfeeding initiation/duration/exclusivity
    CategoricalClinical: Contraceptive initiation/continuation
    CategoricalClinical: Infections
    CategoricalClinical: Mental health diagnoses
    CategoricalClinical: Mortality
    CategoricalClinical: PP onset of preeclampsia or hypertension
    CategoricalClinical: Reduction in Health Inequities
    CategoricalClinical: Severe morbidity - Bleeding
    CategoricalClinical: Severe morbidity - Cardiovascular
    CategoricalClinical: Severe morbidity - Cerebrovascular
    CategoricalClinical: Severe morbidity - Other
    CategoricalClinical: Severe morbidity - Venous thromboembolism
    CategoricalClinical: Unintended pregnancies
    CategoricalHarms: Health Inequities
    CategoricalHarms: Other
    CategoricalHarms: Overutilization of Healthcare
    CategoricalHarms: Patient burden regarding PP care
    CategoricalHarms: Perceived Discrimination
    CategoricalHealthcare Utilization: Adherence to screening/testing
    CategoricalHealthcare Utilization: Attendance at PP visits
    CategoricalHealthcare Utilization: Transition to PCP for long-term care
    CategoricalHealthcare Utilization: Unplanned care utilization
    ContinuousClinical: Awareness of risk factors for long-term ill health
    ContinuousClinical: Fatigue
    ContinuousClinical: Interpregnancy interval
    ContinuousClinical: Mental health symptoms
    ContinuousClinical: Pain
    ContinuousClinical: Perceived Stress
    ContinuousClinical: Quality of Life
    ContinuousClinical: Sexual Well-Being/Satisfaction
    ContinuousClinical: Sleep Quality

    Please see downloadable data for more