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Research Process

Introduction

We searched PubMed, Cochrane Central Register of Controlled Trials, and clinicaltrials.gov to locate 120 relevant

publications since 2005 that examined Hyperemesis Gravidarum. Exclusions were made based on the criteria

shown in the PRISMA Diagram below:

Methods Results

Conclusions 

• There is little consensus amongst researchers about which outcomes should be measured and reported in regards to the treatment of Hyperemesis Gravidarum, as shown by the presence of 57 different reported outcomes.

• The large quantity of outcomes reported, shows a necessity for the standardization amongst reported outcome sets.

• Too frequently do researchers assess outcomes from specific medical interventions using their own methods, prohibiting clinicians from being able to efficiently compare and contrast treatments in choosing the best viable option for patient care.

• In standardizing core outcomes for the treatment of Hyperemesis Gravidarum, Nausea and Vomiting were the most commonly reported outcomes (80/213 total reported outcomes).

Oklahoma State University Center for Health Sciences

Zachary C. Sanchez, Justin Rankin, Kelsey Naumann, Sarah Tran, Blake Umberham, Matthew Holzman MS, Matt Vassar PhD

Common Core Outcomes in the Treatment of Hyperemesis Gravidarum as Reported in Obstetrics and Gynecology Journals

“Core outcome sets are consensus-based, standardized sets of outcomes recommended

for measurement across all clinical trials studying a particular condition. Currently, the diversity

of outcomes and differences in the methods used to measure them present challenges for

evidence synthesis.”

After narrowing down our number of viable articles to 32, we extracted all outcomes reported in each study for

comparison in order to answer our research question: What are the most commonly reported outcomes

observed in the treatment of Hyperemesis Gravidarum?

Figure 1: COS guideline abstraction manual for coding

Commonly Reported Core Outcomes

Coding

Each coder independently coded a subset of articles based on a standardized

approach.

Consensus

Discrepancies were solved by group

consensus.

Verification

Validity was checked by a second coder, who verified each coded element.

Nausea:29

Nausea:29

Vomiting/Retching:24

Vomiting/Retching:24

NauseaandVomiting:27

NauseaandVomiting:27

SideEffects:27

SideEffects:27

Medications:30

Medications:30

Labs/Vitals:14

Labs/Vitals:14

Behav ior:9

Behav ior:9

Infant:15

Infant:15Other:4

Other:4QOL/Well-Being:17

QOL/Well-Being:17Hospital:13

Hospital:13

Nausea Vomiting/Retching Nausea and Vomiting Side EffectsMedications Labs/Vitals Behavior Infant OtherQOL/Well-Being Hospital

meta-chart.com

Figure 3: Breakdown of the 58 Recorded Outcomes into 11 Broad, All-Encompassing Domains

B6 and Hormone Levels

Small for Gestational Age

Adverse Effects

Amount of Intravenous that was

Antiemetic Use

Anxiety

Aversion for Specific foods or food categories

Blood Results (serum sodium, potassium, chloride, and plasma glucose)

Compliance

Congenital Birth Defects

Craving for Specific Foods or Food Categories

Depression

Drowsiness

Dry Retching Frequency

Duration of IV Antiemetic Use

Duration of IV Rehydration

Food Groupings of Commonly Reported Cravings and Aversions

Gestational Age

Heartburn

If Second or Third-line Antiemetic Medication was Required

Infant Sex Ratio

Ketonuria in Urine

Length of Hospital Admission

Length of Hospital Stay

Mode of Delivery

Nausea

Nausea and vomiting

Nausea and Vomiting Frequency

Nausea and Vomiting Impact

Nausea and Vomiting Severity

Nausea Frequency

Nausea Severity

Neonatal Health

Neonate Birthweight

Number of days off Intravenous Therapy Compared in the Two Periods

Occurrence of Side Effects

Open-label use of IV Metoclopramide After Study

Oral Intake

Outcome of Pregnancy

Patient Satisfaction

Preeclampsia

Pregnancy Induced Appetite Sensations and Symptoms

Pregnancy Related Behaviors

Quality of Life

Rate of Food Intake

Recording of First Oral Intake

Request Compassionate Continuation of Intervention

Response to Medication

Spontaneous Preterm Birth

Stress Level

Total Admissions

Total Number of Antiemetic Doses Required

Treatment Curtailment

Vomiting

Vomiting Frequency

Vomiting Without Nausea

Weight Change

Well Being

0 4 8 12 16

Figure 2: A Summary of the 58 Commonly Reported Outcomes in the Treatment of Hyperemesis Gravidarum

“The Standardization of outcomes for clinical trials has been proposed as a solution to the problems of inappropriate and non-uniform outcome selection and reporting bias.”

“Sets of standardised outcomes measures are not meant to stifle the development and use of other outcomes. Rather, they provide a core set of outcome measures, which researchers should use routinely. . . Achieving consistency is not something that can be left to serendipity. It will require consensus, guidelines and adherence.””

Contrary to popular belief, consistent outcomes are more important than variable outcomes. Much like a husband should appreciate knowing the symptoms

that his wife will experience while pregnant, physicians should have the ability to expect a

common set of outcomes based on the research they read when treating their patients.