Title: Interventions for promoting participation in Shared decision-making for children and adolescents with cystic fibrosis.
Objective: To determine the effectiveness of interventions that promote shared-decision making (SDM) for children and adolescents with cystic fibrosis aged 4 to 18 years of age. Shared decision-making (SDM) is defined as a patient centered, collaborative process that enables individuals and their healthcare providers to make decisions together (IMDF 2014).
Why it is important to undertake this review: Shared decision-making has strategic relevance and importance within the healthcare context in the island of Ireland. Such is its importance that the Shared decision- making process is addressed under ‘Participation’, which is one of the eight under-pinning principles outlined in ‘The National Healthcare Charter – you and your Health Service’ (2012). The charter considers a patient to be an individual of any age and promotes greater patient involvement in decision-making through the asking of questions about care. This review focuses on shared decision-making in relation to children and adolescents. In 1992, Ireland ratified the United Nations Convention on the Rights of the Child (UNCRC). The Convention affirms respect for the views of children in matters that affect them and places value and importance on the child’s opinion with the statement: “Parties shall assure to the child who is capable of forming his or her own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child” (United Nations 1989). The Government of Ireland through ‘The National Children’s Strategy’ (2000) acknowledges that the child has a valuable contribution to make and the strategy outlines that giving a child a voice means explaining the decisions taken, especially when the views of the child cannot be fully taken into account. With a growing interest on engagement of children as partners in their own heath care, there is a need for increased understanding of effective ways to promote shared decision making (Lipstein 2015). Children can engage in the decision-making process independent of whether the final decision rests with others. For example, children can contribute to information exchange (Millar 2008) and express opinions or preferences (Joffee 2003). This systematic review aims to identify interventions that are known to work, are evidence based, and involve children in the decision-making process.
Description of the condition: Cystic fibrosis (CF) is a genetic disease with significant variations in incidence, morbidity and mortality around the world. The Republic of Ireland has the highest prevalence of CF in the world at 2.98 per 10,000 per head of population (Cystic Fibrosis Registry of Ireland 2014; Farrell 2008a). Children with Cystic Fibrosis (CF) can be challenged with complex healthcare decisions. As the child with CF grows older healthcare becomes more complex requiring consultations with an expanded multidisciplinary team of specialists (Quon 2012). In so far as SDM is associated with beneficial healthcare outcomes (Elf 2015) clarification of a SDM intervention model for children with CF becomes increasingly relevant. Findings from a study carried out in Ireland highlighted the need to acknowledge cystic fibrosis children as active participants in their dietary care (Savage 2007).
The PICO is as follows: Population: Children and adolescents diagnosed with cystic fibrosis clinically (Farrell 2008) by sweat test (McKone 2015) or genetically (Martiniano 2014) aged between 4 and 18 years of age.
Intervention: We will include SDM interventions for children with cystic fibrosis that focuses primarily on the child but may include carers, parents or healthcare professionals. For example, interventions on information exchange, checking understanding, eliciting preferences, agreeing upon a care plan, reviewing choices. Interventions may include any context in which the child’s views about treatment options are valued, for example: mobile phone messaging, online sessions, leaflets, workbooks, and self-management educational interventions.
Comparators: We will compare interventions for promoting participation in shared decision-making aimed at children or adolescents or parents or healthcare professionals (or combinations of these groups) to usual care or to alternative SDM interventions.
Outcomes: Primary outcomes
Presence of shared decision-making measured by any validated tool, such as: · the observing patient involvement 12 item (OPTION) scale (Elwyn 2003) · the observer-based measure observer 5 item (OPTION) scale (Elwyn 2012) · Decision-making instruments
i Facilitation antecedents (e.g. Preparation for Decision-Making scale (Graham 1995) ii Decision process (e.g. Rochester Participatory Making Scale (Shields 2005)
Secondary outcomes: 1. Anxiety (as defined by (Spielberger 1973)
2. Decision regret (as measured by the Decision Regret Scale (Brehaut 2003)
3. Decision conflict (as measured by the SURE scale (Légaré 2010)
4. Participant satisfaction (Quaschning 2013)
5. Adverse effects (e.g. longer consultation times or increased costs (Légaré 2014)
6. Adherence to CF medication as measured (e.g. electronic monitoring (Siracusa 2015)
