Use of a decision aid for prenatal testing of fetal abnormalities to improve women’s informed decision making: a cluster randomised controlled trial [ISRCTN22532458]

Abstract

Objective To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making.Design A cluster randomised controlled trial.Setting Primary health care.Population Women in early pregnancy consulting a GP.Methods GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting.Main outcome measures Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post.Findings Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes.Conclusion A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values.

Measuring informed choice in population-based reproductive genetic screening: a systematic review

“…11,13,26,[28][29][30][31][32][33][34][35] Twenty-two studies were prospective, 12,28,[36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52][53][54][55] including cross-sectional, 41,42,49 quasi-experimental, 53 pilot, 50 and longitudinal study designs. 52 Of the RCTs, five involved an information or educational intervention, 28,29,[32][33][34] five randomised the screening offer, 11,13,26,30,35 and there was one decision aid trial.…”

“…52 Of the RCTs, five involved an information or educational intervention, 28,29,[32][33][34] five randomised the screening offer, 11,13,26,30,35 and there was one decision aid trial. 31 The 33 studies were published between 1991, 54 and 2012, 36 with 25 studies published between 2002 and 2012. Three studies used the same cohort as in previous studies; 13,39,46 in subsequent studies the sample was stratified differently, 40 different measures were applied, 11 and additional validation data were reported.…”

“…45 Eight studies were conducted in continental Europe, 11,13,38,[43][44][45][46]53 and 14 were from the United Kingdom. 12,26,29,30,[32][33][34][35]37,[39][40][41]51,54 Seven studies were from Australia, 31,36,[48][49][50]52,55 three from the United States, 28,42,56 and one from Taiwan. 47 Prenatal screening for DS was the most common screening programme evaluated (27 studies).…”

“…47 Prenatal screening for DS was the most common screening programme evaluated (27 studies). [11][12][13]28,29,[31][32][33][34][35][37][38][39][40][42][43][44][45][46][47][48][49][51][52][53]55,56 Three studies offering population carrier screening in prenatal settings included screening single gene disorders: sickle cell disease and thalassaemia (haemoglobinopathies (Hb)) 26,41 and cystic fibrosis (CF). 30 Of the 33 studies reviewed, only one included partners of the pregnant women, 30 and one offered CF carrier screening to men as well as women.…”

A Randomized Trial of a Prenatal Genetic Testing Interactive Computerized Information Aid

“…[10][11][12][13] Use of decision aids for prenatal counseling using structured, paper-based or basic electronic tools has been associated with less decision conflict, improved knowledge, and in some cases, increased uptake of prenatal testing. [14][15][16][17][18] Such tools can facilitate an improved informed consent process, yet few decision aids have been developed and evaluated in the United States, particularly for use in low literacy populations. 11 In 2009, Kuppermann et al showed that use of an interactive prenatal diagnostic decision tool resulted in better patient satisfaction, more decision certainty, and more accurate estimates of risk among women receiving prenatal genetic counseling.…”