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Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.
Women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (MMIC) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention was a 16-minute educational video created by the study investigators which provided information about Down syndrome, diagnostic tests and screening tests. The screening tests covered in the video included the triple test, the combined first trimester screen and non-invasive prenatal screening. Information about how and when each of the tests were performed, their detection rates and possible results and their interpretations were covered in the video. The video was viewed by several healthcare providers and experts in the field of prenatal screening before the commencement of this study to ensure that the content was appropriate and adequate. The intervention was viewed by subjects on a portable tablet in a quiet room in the antenatal clinic. Subjects were then invited to ask their doctor any questions that they may have had about the video during the clinic consult which followed. |
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| Control | No Intervention | Women in the control group were counselled by the referring doctor regarding the aneuploidy screening options of FTS or NIPS, and provided information about the procedures involved for each test, their detection rates, cost, and possible results of testing. The use of a written information leaflet was available to doctors as an adjunct to providing this information. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced (intervention) education | Behavioral | See arm description |
|
| Measure | Description | Time Frame |
|---|---|---|
| Informed choice | Outcome will be measured using the modified multidimensional measure of informed choice (MMIC). | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Deliberation | Outcome will be measured using 6 questions to measure deliberation on a five-point Likert scale | Day 0 |
| Knowledge | Outcome will be measured using a 19-item validated true/false knowledge questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36550063 | Derived | Xian Lim KM, Lewis C, Wong HC, Chong GSL, Gosavi A, Choolani MA. Does an educational video for aneuploidy screening improve informed choice among pregnant women? A randomised controlled trial. Prenat Diagn. 2023 Jan;43(1):42-50. doi: 10.1002/pd.6279. Epub 2022 Dec 28. |
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| ID | Term |
|---|---|
| D000782 | Aneuploidy |
| D004314 | Down Syndrome |
| ID | Term |
|---|---|
| D002869 | Chromosome Aberrations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008607 | Intellectual Disability |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Day 0 |
| Value-consistent behaviour | Attitudes towards testing options were assessed using a validated questionnaire and deemed to be value consistent if a participants had a positive attitude towards the test option that they chose, or a negative attitude towards all test options and chose not to test. | Day 0 |
| anxiety | Anxiety was assessed using the Spielberger State trait anxiety inventory (STAI-6) short form which consisted of 6 items | Day 0 |
| Decisional Conflict | Decisional conflict was measured using a validated Decisional Conflict Scale (DCS) | Day 0 |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |