| Literature DB >> 22189349 |
Rebecca Say1, Stephen Robson, Richard Thomson.
Abstract
Objectives Patient decision aids can be used to support pregnant women engaging in shared decisions, but little is known about their effects in obstetrics. The authors aimed to evaluate the effects of patient decision aids designed for pregnant women on clinical and psychosocial outcomes. Design Systematic review. Data on all outcomes were extracted and summarised. All studies were critically appraised for potential sources of bias and, when possible to obtain, the reported decision aids were evaluated. Meta-analysis was not possible due to the heterogeneity of outcomes in primary studies and the small number of studies. Data sources Electronic searches were performed using Medline, Embase, the Cochrane Library and Medion databases from inception until December 2010. Reference lists of all included articles were also examined and key experts contacted. Eligibility criteria for selecting studies Eligibility criteria included randomised controlled trials, which reported on patient decision aids for women facing any treatment decision in pregnancy published in English. Studies evaluating health education material that did not address women's values and preferences were excluded. Results Patient decision aids have been developed for decisions about prenatal testing, vaginal birth after Caesarean section, external cephalic version and labour analgesia. Use of decision aids is associated with a number of positive effects including reduced anxiety, lower decisional conflict, improved knowledge, improved satisfaction and increased perception of having made an informed choice. Conclusions Patient decision aids have the potential to improve obstetric care. However, currently the evidence base is limited by the small number of studies, the quality of the studies and because they involved heterogeneous decision aids, patient groups and outcomes.Entities:
Year: 2011 PMID: 22189349 PMCID: PMC3334824 DOI: 10.1136/bmjopen-2011-000261
Source DB: PubMed Journal: BMJ Open ISSN: 2044-6055 Impact factor: 2.692
Figure 1PRISMA 2009 flow diagram, from Moher et al.15 Visit http://www.prisma-statement.org for more information.
Summary of studies included in the review
| Author | Participants | Decision aid | Control | Outcomes | Results |
| Bekker | 117 women receiving a screen- positive maternal serum test for Down's syndrome (risk ≥250) at Leeds General Infirmary over 15 months. NHS patients, literate in English. | Decision analysis consultation | Routine consultation | Decision whether or not to have diagnostic test (amniocentesis or CVS) | No difference |
| Subjective expected utilities | No difference in expected utility values (other than terminating a baby with Down's syndrome which women in the intervention arm valued more highly) Women in the intervention arm evaluated information in relation to their own values more than those in the control arm. | ||||
| Knowledge | No difference | ||||
| Informed decision making | Decision analysis women evaluated more information | ||||
| Risk perception | More decision analysis women perceived their screening test to be medium rather than high risk | ||||
| Decisional conflict | Decreased over time with intervention | ||||
| Anxiety | No difference | ||||
| Perceived usefulness of consultation | No difference | ||||
| Perceived directiveness of consultation | No difference | ||||
| Length of consultation | Decision analysis longer | ||||
| Graham | 1050 women booking antenatal care at Aberdeen Maternity Hospital between April 1997 and January 1998 | Touch screen information system | Information leaflet | Uptake of prenatal tests (booking ultrasound scan, serum screening, detailed anomaly scan, amniocentesis, chorionic villus sampling) | More women in the intervention group underwent detailed anomaly scanning. No difference in other tests |
| Understanding of prenatal tests | No difference | ||||
| Satisfaction with information | No difference | ||||
| Anxiety | Reduced in the intervention group | ||||
| Use of information leaflet | No difference | ||||
| Hewison | 2000 consecutive women referred for antenatal care at Hull Maternity Hospital | Video | Routine care | Uptake of screening (second trimester serum screening) | No difference |
| Knowledge | Improved knowledge in the intervention group | ||||
| Anxiety | No difference | ||||
| Worries abnormalities | No difference | ||||
| Worries about screening tests | No difference | ||||
| General worries about pregnancy/childbirth | No difference | ||||
| Hunter | 352 pregnant women aged ≥35 years | Case examples and worksheet | Individual or group genetic counselling | Knowledge | Increased knowledge in all groups: highest knowledge levels with group counselling |
| Anxiety | No difference | ||||
| Decisional conflict | Decreased with PDA | ||||
| Satisfaction | Less satisfied with PDA than individual counselling | ||||
| Leung | 201 low-risk Chinese women attending prenatal clinic in Hong Kong before 20 weeks of gestation Chinese speaking | Interactive multimedia decision aid | Information leaflet and 30 min video | Uptake of screening tests (integrated screening test <15/40, serum screening >15/40, amniocentesis/CVS for women >35) | No difference |
| Initial decision about screening after intervention | No difference | ||||
| Understanding and satisfaction with the information they had received | Women who used the decision aid had fewer additional questionsNo difference in satisfaction | ||||
| Montgomery | 742 pregnant women with one previous lower segment caesarean section and delivery expected >37 weeks | Two computer-based interventions. 1) Information programme: descriptions and probabilities of clinical outcomes 2) Decision analysis mode of delivery was recommended based on utility assessments combined with probabilities of clinical outcomes within a decision tree | Usual care | Decisional conflict | Decreased with both decision aids |
| Mode of delivery | No difference | ||||
| Anxiety | Decreased with both decision aids | ||||
| Knowledge | Increased with both decision aids | ||||
| Satisfaction with the decision | Satisfaction higher in decision analysis group than with usual care. No other differences | ||||
| Nagle | Community (Australia). 55 clusters, 467 low-risk women aged >18 years, ≤12/40, English speaking, able to give informed consent | Booklet—24 pages designed using Ottawa Decision Framework | Standard pamphlet | Informed choice including knowledge subscale | OR making an informed choice with decision aid 2.08 (95% CI 1.14 to 3.81). |
| Intention to have screening | No difference | ||||
| Decisional conflict | No difference | ||||
| Anxiety | No difference | ||||
| Depression | No difference | ||||
| Attitudes to pregnancy/fetus | No difference | ||||
| Acceptability of resource | No difference | ||||
| Acceptability of screening | No difference | ||||
| Nassar | 200 women with a singleton breech pregnancy at term, clinically eligible for ECV, four tertiary obstetric units Australia | 24-page booklet with 30 min audio CD and worksheet | Standard care | Knowledge | Increased with PDA |
| Decisional conflict | Decreased with PDA | ||||
| Anxiety | No difference | ||||
| Satisfaction with decision making | No difference in satisfaction with decision making but more women in the PDA group were satisfied with the amount of information they received | ||||
| Participation in decision making | No difference | ||||
| Attitudes of the importance of undergoing an ECV | More women in the PDA group had a positive attitude towards ECV | ||||
| Intended choice | PDA group more likely to favour ECV | ||||
| ECV uptake | No difference | ||||
| Maternal and perinatal outcomes (presentation at birth, mode of delivery, Apgar scores, infant sex, gestational age, infant birth weight, maternal length of stay) | No differences | ||||
| Raynes-Greenow | Primiparous women in the third trimester planning a vaginal birth of a singleton infant in two obstetric hospitals, Sydney Australia | 55-page booklet with worksheet and 40 min audio CD | Four-page pamphlet developed and endorsed by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists and the Australian Society of Anaesthetists | Knowledge | Increased knowledge with PDA use |
| Decisional conflict | No difference | ||||
| Anxiety | No difference | ||||
| Satisfaction with decision making | No difference | ||||
| Intended choice of analgesia | No difference | ||||
| Analgesia use | No difference | ||||
| Participation in decision making | No difference in preferred role. Women using PDA more likely to report seriously considering their care providers opinion | ||||
| Adherence and acceptability | No difference | ||||
| Impact on service outcomes (analgesia, maternal and perinatal outcomes including mode of delivery) | No difference | ||||
| Shorten | 227 Women with one previous caesarean section and medically eligible for a trial of vaginal birth | Decision-aid booklet | Usual care | Knowledge | Intervention increased knowledge |
| Decisional conflict | Intervention decreased decisional conflict | ||||
| Preferred mode of delivery 36 weeks | No difference | ||||
| Satisfaction 6–8 weeks postnatally | No difference | ||||
| Mode of delivery | No difference | ||||
| Thornton | 3368 Women attending antenatal clinics in Bradford Infirmary and Leeds General Infirmary between <15/40 | Additional individual information at an extra hospital visit supported by extra written information or extra class supported by extra information | Information sheet and routine consultation | Uptake of prenatal tests (detailed anomaly scan, serum screening, amniocentesis) | No difference in uptake of ultrasound or amniocentesis. Increased uptake of Down's syndrome serum screening with individualised information (no difference with group with extra information) Decreased uptake of cystic fibrosis testing with both interventions |
| Knowledge | Women felt that they understood information better in both intervention groups | ||||
| Anxiety | Anxiety reduced with individual information at 20/40, 30/40 and 6 weeks post partum | ||||
| Anxiety measure specific to pregnancy and fetal abnormality | Women offered individual information were less worried about the baby at 20/40 than those offered classes |
CVS, chorionic villus sampling; ECV, external cephalic version; PDA, patient decision aid.
Summary of the quality of studies included in the review
| Author | Randomisation | Blinding | Follow-up and analysis | Included in Cochrane review? |
| Bekker | Simple randomisation with numbered sealed opaque envelopes Allocation concealment adequate | Not described | Number of withdrawals stated but reasons not given Intention-to-treat analysis | Yes |
| Graham | Simple randomisation with numbered sealed opaque envelopes Allocation concealment adequate | Not described | Data entry checked for accuracy Number of withdrawals stated and that there were no significant differences between women followed up and women withdrawing Intention-to-treat analysis | Excluded (general information with lack of focused decision) |
| Hewison | Pseudo-randomisation with women allocated on the basis of having either an odd or even unit number Women were pseudo-randomised without consent (sent a letter with either intervention/control leaflet stating that new methods of information provision were under evaluation and that women may be asked to complete questionnaires during their pregnancy) State that unit numbers were allocated consecutively by staff not participating in the study Allocation concealment not adequate | Not described. | No flow chart Psychological endpoint and demographic questionnaire only sent to first 1200/2000 women randomised because of limited time for follow-up Number of withdrawals stated but reasons not given No CIs | Excluded (did not meet criteria for definition of decision aid as no values clarification) |
| Hunter | Randomised in blocks of 30 (10 women into each intervention group) using allocations in opaque envelopes Allocation concealment adequate | Not described | Non-participants were compared with participants across a variety of criteria. Significant differences included: more non-participating women had children prior to prenatal diagnosis counselling; more participating women disclosed exposure to alcohol, cigarettes, medication (including chemotherapy and radiotherapy) or street drugs in pregnancy; more participating women brought their partner to prenatal diagnosis counselling No flow chart No CIs | Yes |
| Leung | Simple randomisation with numbered sealed opaque envelopes Allocation concealment adequate | Not described | Number of withdrawals stated but reasons not given Intention-to-treat analysis | Yes |
| Montgomery | Computer-generated block randomisation with allocation stratified by maternity unit and baseline preference for mode of delivery Allocation concealment adequate | Not described | Intention-to-treat analysis Number of withdrawals stated Compared women who did and did not consent (participants older and less deprived) but no statement of withdrawals | No (published after last update) |
| Nagle | Computer-generated cluster randomisation using individual general practitioners as the unit of randomisation Allocation concealment adequate | Not blinded | Intention-to-treat analysis Number of withdrawals stated and reasons given | No (published after last update) |
| Nassar | Computer-generated block randomisation stratified by parity and centre allocated via remote telephone Allocation concealment adequate | Women and research team not blindedAntenatal staff blinded | Intention-to-treat analysis No difference in maternal age, level of education, parity or treatment allocation between responding participants and those lost to follow-up | No (published after last update) |
| Raynes-Greenow | Computer-generated block randomisation allocated via remote telephone Allocation concealment adequate | Women not blinded but unaware that the control pamphlet was not the interventionAntenatal staff blinded to format and content of the decision aid | Intention-to-treat analysis Number of withdrawals stated but reasons not given | No (published after last update) |
| Shorten | Computer-generated block randomisation Allocation concealment adequate | Participants initially blinded to their allocation but use of decision aid as specified would potentially negate blinding | Intention-to-treat analysis Number of withdrawals stated but reasons not given | Yes |
| Thornton | Simple randomisation with numbered sealed opaque envelopes Allocation concealment adequate | Not described | No statement of withdrawals Intention-to-treat analysis Included Urdu-speaking women as trained an Urdu-speaking doctor | Excluded (authors unable to evaluate if met criteria for decision aid) |