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Interventions for Promoting Participation in shared decision-making for Children and Adolescents with Cystic Fibrosis

Introduction
Caesarean section (CS) rates have increased globally over the last 30 years (Lavender et al, 2012; O’Neill et al, 2013; ACOG, 2013). In the UK, CS rates increased from 9% in 1980 to 25% in 2013 (NICE, 2013) and almost one in three women currently deliver by CS here in Ireland (AIMS Ireland, 2012). Recently, women are requesting a CS for their first pregnancy without medical indication. CS on maternal request (CSMR) is defined by the American College of Obstetricians and Gynecologists (ACOG) as a primary pre-labour caesarean delivery on maternal request in the absence of any maternal or fetal indications (ACOG, 2013). The incidence of CSMR is not widely known. Therefore its effect on reducing overall rates of CS is not known. The National Sentinel Caesarean Section Audit in 2001 reported that 7% of births in the UK were CSMR (Thomas et al, 2001). Thus, this is of serious concern for midwives, obstetricians, hospitals and policy makers. CS may have serious consequences for both mother and baby; for example longer maternal hospital stay and increased risks for future pregnancies (O’Neill, 2013). When comparing a planned vaginal birth with a planned CS, it is recommended that, where not medically indicated, women are encouraged to aim for a vaginal birth since it is safer and more appropriate (ACOG, 2013). Where women would like to have several children, CSMR is not recommended due to significant risks in particular, the risk of placenta previa, placenta accreta and gravid hysterectomy. Other reasons a woman may consider a CS rather than a vaginal birth include anxiety, previous traumatic birth experience, multiple births including twins (where the first twin is cephalic), breech presentation, and suspected fetal macrosomia (birth weight greater than 4000g). There is a growing expectation that pregnant women are involved in decision making and are encouraged to become active partners in their own care. There is evidence that women feel burdened by the decision-making process around birth and worry that they will make a ‘wrong’ decision (Roosevelt and Lowe, 2015). Therefore, women need information to support them in their decision-making about first caesarean delivery. Interventions designed to support women in their decision-making are helpful to ensure this is an ‘informed choice’. The National Institute for Health and Care Excellence (NICE) Quality Statement recommends that pregnant women who ask for a CSMR have a documented discussion with the maternity team (Midwife, Obstetrician and Anaesthetist) about the risks and benefits of a CS versus a vaginal birth (NICE, 2013). It is recommended that pregnant women who request a CS because of anxiety are referred to a perinatal mental health support team (NICE, 2013). CS may be recommended for these women.
Eligibility/ Participants Pregnant women who are making a decision on first caesarean delivery will be included in this study. We will exclude women with known multiple pregnancy (i.e. twins or more).
Interventions
Interventions designed specifically to support pregnant women who are making a decision on first caesarean delivery will be included in this review. We will categorise interventions into three broad types.
1. Independent (such as web-based decision aids which the woman administers herself).
2. Shared (such as decision-coaching with a health care provider).
3. Mediated (such as telephone decision-coaching).
Providing information which is evidence-based in the antenatal period communicated in a way that is accessible and understandable to pregnant women is recommended in the current NICE Guidelines for CS (NICE, 2013). Information and cultural needs of minority cultures and women who cannot read or who do not use English as their primary language as well as those with learning difficulties should be considered (NICE, 2013). Decision aid tools have focused on increasing knowledge, reducing anxiety and decisional conflict, aiming to promote women’s birth satisfaction, clarifying values and instilling participation in decision-making, facilitating the counselling task in maternity teams (Dugas et al, 2012) Decision support tools work in different ways to help women make a decision about how they give birth. Firstly, women may self-administer the intervention, working independently to further their knowledge. Secondly, interventions may be delivered by the health care professionals involved in a pregnant woman’s care. Lastly, the intervention may be delivered by a third party (Dugas et al, 2012). Different interventions used include telephone decision coaching services, decision-aids, one-to-one counselling, group information sessions and decision protocols or algorithms. Interventions may increase a woman’s knowledge concerning mode of birth, reduce anxiety and ultimately may reduce the number of CSMR.
Comparison
The intervention group will be compared to pregnant women who had standard care or no formal decision support process.
Outcomes
We will include outcomes as reported by trial authors that are applicable to women, health care professionals and policy makers.
Primary
· Planned mode of birth
· Proportion of women with congruence for planned and actual mode of birth
· Adverse maternal outcomes, categorised as:
1. permanent: ongoing adverse impact
2. severe: where there is risk of death and significant costs in terms of time, emotional distress and
resources
3. major: no risk of death but significant costs in terms of time, emotional distress and resources
4. non-major: no risk of death/ minor costs
5. unclear: where impact is unable to be determined from the available data
· Adverse neonatal outcomes, categorised as:
1. permanent: ongoing adverse impact
2. severe: where there is risk of death and significant costs in terms of time, emotional distress and resources
3. major: no risk of death but significant costs in terms of time, emotional distress and resources
4. non-major: no risk of death/ minor cost
5. unclear: where impact is unable to be determined from the available data
Secondary
Maternal Outcomes:
· Actual mode of birth
· Decisional conflict (Decisional Conflict Scale)
The decisional conflict scale (DCS), a sixteen item checklist and the shortened version (Sure of myself; Understand information; Risk-benefit ratio; Encouragement: SURE) for clinical practice, four item checklist, measures personal perceptions of:
1. uncertainty in choosing options;
2. modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and
3. Effective decision making (in full version) such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
· Decisional regret (Decisional Regret Scale)
The Decision Regret Scale, a five item scale measures “distress or remorse after a [health care] decision.”
· Knowledge and understanding of the options for mode of birth and possible outcomes
· Information needs met
· Satisfaction with decision-making process
· All adverse outcomes reported
(Maternal mortality and morbidities)
Neonatal Outcomes:
· Neonatal mortality and morbidity Subgroup Analyses
Type of Intervention (decision support)
· Independent versus shared versus mediated
· Computer-Based Tool versus Paper-Based Tool
Why it is important to carry out this review
This Cochrane Review will collate the best available evidence about interventions for supporting pregnant women’s decision-making for first caesarean delivery thereby influencing current clinical practice, local and national guidelines. More evidence is needed to support the promotion of informed choice, involving the woman as a partner in her care pathway. There is the potential to reduce CS rates if the best available interventions are adopted to counsel women in relation to their first mode of birth. Reducing CS rates may lead to long term benefits such as better birth outcomes for subsequent pregnancies, less major puerperal infection, anaesthetic complications, haemorrhage requiring hysterectomy and less neonatal adaptation problems like respiratory issues, hypoglycaemia and hypothermia in term babies (ACOG, 2013). Economic benefits will include less costs due to reduced hospital stay and less maternal and neonatal morbidity (ACOG, 2013).