Core Outcome Measures in Effectiveness Trials

Reported Outcomes in Perinatal Iron Deficiency Anemia Trials: A Systematic Review

General Information

Abstract:
BACKGROUND/AIMS:

Iron deficiency (ID) and iron deficiency anemia (IDA) are global health concerns associated with adverse perinatal effects. Despite efforts taken at the international level, there is no consensus on unified prevention/treatment strategies, largely stemming from inconsistencies of outcome reporting. Our objective was to comprehensively assess outcome reporting perinatal iron intervention trials as Phase 1 of core outcome set (COS) development to inform future research.

METHODS:

Systematic search in MEDLINE, EMBASE, Cochrane Databases, and CINAHL (January 2000 - April 2016), with inclusion of trials involving pregnant or postpartum women with ID/IDA confirmed before recruitment. Articles were independently screened and selected by 2 reviewers; data were extracted in duplicate. Quality was assessed using published scoring systems. Outcome definitions and measurement methods were tabulated.

RESULTS:

Of 7,046 citations, 33 randomized controlled trials were included. Sixty-nine reported outcomes were categorized into 8 domains. High methodological quality characterized 25 (76%) studies. Reporting quality was low in 16 (49%), moderate in 13 (39%), and high in 4 (12%) studies. Variation was greatest for outcome definition, timing of assessment and measurement methods.

CONCLUSION:

This review identifies a comprehensive long-list of outcomes reported of perinatal iron interventions for ID/IDA. Beyond highlighting existing variation in outcome reporting, it provides a foundation for development of a COS for future trials.

Authors:
Malinowski AK, D'Souza R, Khan KS, Shehata N, Malinowski M, Daru J.

Publication

Journal:
Gynecol Obstet Invest.
Volume:
1
Issue:
Pages:
1 - 18
Year:
2019
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Blood disorders
Pregnancy & childbirth

Disease Name
Anemia
Iron Deficiency Anaemia

Target Population

Age Range
16 - 55

Sex
Female


Nature / type of Intervention
Other

Method(s)

Systematic review

Systematic search in MEDLINE, EMBASE, Cochrane Databases, and CINAHL (January 2000 - April 2016), with inclusion of trials involving pregnant or postpartum women with ID/IDA confirmed before recruitment. Articles were independently screened and selected by 2 reviewers; data were extracted in duplicate. Quality was assessed using published scoring systems. Outcome definitions and measurement methods were tabulated.


Stakeholders Involved

Study investigators

Study Type

Systematic review of outcomes measured in trials

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