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Federal Register / Vol. 86, No. 161 / Tuesday, August 24, 2021 / Notices PICOTS POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTINGContinued Category
Definition
Study Design

Timing

Setting

D Small for gestational age e.g., birth weight <10% for similar age neonates, low birth weight e.g., <2.5 kg 5 lb, 8 oz.
D Abnormal Apgar score threshold, e.g. <7.
D Breastfeeding must be adjusted to account for patient preferences.
D Need for social services.
Care utilization:
D Attendance at planned antenatal visits adherence/compliance.
D Completion of ACOG recommended services.
D Number of unplanned visits.
D Number of referrals to other providers.
D Unplanned hospital admissions.
D Emergency room/triage visits.
D Neonatal intensive care unit NICU admissions /length of stay.
D Number of unplanned contacts e.g., portal/phone messages.
Provider outcomes:
D Provider satisfaction with antenatal care.
Harms:
D Overdiagnosis unnecessary negative workups or misdiagnoses.
D Delayed diagnoses e.g., gestational diabetes.
D Harms to marginalized groups/equity outcomes.
KQ3:
Perspectives and preferences related to interventions covered by KQ 1 and KQ 2.
Barriers and facilitators related to interventions covered by KQ 1 and KQ 2.
KQ1 & KQ2:
Comparative studies comparisons of different interventions, including parallel design, pre-post studies, and other comparisons.
D Randomized or observational nonrandomized.
D Prospective or retrospective.
Surveys that compare interventions specifically for patient preferences and satisfaction.
Registry e.g., PRAMS Pregnancy Risk Assessment Monitoring System, National family study and other retrospective data sources may be eligible, but only if the comparison is between different numbers of planned or scheduled visits KQ1 or if there is a specific evaluation of telemedicine KQ2.
Single group studies no direct comparison of interventions.
D Preference and satisfaction outcomes only.
N 10 per intervention group.
Existing systematic reviews and guidelines will be used as sources of otherwise missed eligible studies.
KQ3:
Qualitative studies.
Interviews.
Focus groups.
Ethnographic studies.
Surveys with open-ended questions amenable to qualitative analysis.
KQ1 & KQ2:
Interventions: During antenatal period excluding labor and delivery.
Followup/Outcomes: Any antenatal, peripartum, postpartum, or later.
KQ3:
Any as long as interventions of interest occurred during antenatal period.
All KQs:
High income countries based on World Bank classifications.
Outpatient care.

Dated: August 18, 2021.
Marquita Cullom, Associate Director.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

FR Doc. 202118125 Filed 82321; 8:45 am
Agency for Healthcare Research and Quality
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Agency Information Collection Activities: Proposed Collection;
Comment Request Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the intention of the Agency for Healthcare Research and Quality AHRQ to request
SUMMARY:

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that the Office of Management and Budget OMB approve the renewal of the information collection project Medical Office Survey on Patient Safety Culture Database. This proposed information collection was previously published in the Federal Register on May 3rd, 2021 and allowed 60 days for public comment. AHRQ did not receive any substantive comments from members of the public. The purpose of this notice is to allow an additional 30
days for public comment.
Comments on this notice must be received by September 23, 2021.

DATES:

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