Family‐centred care for children in hospital
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
The primary objective of this review is to assess the effects of family‐centred models of care for hospitalised children when compared to standard or professionally‐centred models of care, on child, family and health service outcomes.
A secondary objective of this review is to assess whether the effects of family‐centred models of care for hospitalised children, when compared to standard or professionally‐centred models, differ according to:
(1) Degree of family‐centredness
High degree of family‐centred care, ie. scores for family‐centredness of 70 or greater (see Methods section for description of ratings).
(2) Population of children:
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premature infants being cared for in a neonatal intensive care or special care nursery;
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children admitted to hospital in the period from discharge after birth episode to 5 years of age;
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children admitted to hospital from 6 to 12 years of age;
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children admitted to hospital for surgery;
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children with a chronic health condition (ie. a physical, mental, emotional, behavioural, or developmental disorder expected to last 12 months or longer, or having sequelae that last 12 months or longer, and requiring treatment and/or monitoring (Gay 1997).
Due to the complex nature of family‐centred care and the heterogeneity of possible interventions, it is difficult to pre‐specify which comparisons will be possible. Therefore, a decision about comparison groups will be reached through consensus between the review team and the Cochrane Consumers and Communication Review Group editorial team after the final search is completed. Depending on the outcome, it may be necessary to revise the protocol.
Background
Historical Background
Until at least the late 1950s, hospitals worldwide tended to be bleak places for children. It was believed that visits from parents would inhibit effective care (Nethercott 1993) and were detrimental to the child, who would become distressed when the parents left (Alsop‐Shields 1998; Johnson 1990). Researchers began to suggest, however, that children whose parents did not visit them suffered acute emotional trauma which may have long‐term psychological consequences in adolescence and adulthood (Bowlby 1971; Bowlby 1973).
In 1956, the British government commissioned a report into the welfare of children in hospital. The resulting report, the Platt Report (Platt 1959), recommended that visiting be unrestricted, that mothers stay in hospital with their child, and that training of medical and nursing staff should promote understanding of the emotional needs of children. The process of change has resulted in a humanisation of paediatrics (Darbyshire 1994), although the movement away from traditional approaches to health service delivery to the involvement of families in all aspects of the planning, delivery, and evaluation of health care has been slow (Palmer 1993). The foundation for a family‐centred approach to paediatric health care is the belief that a child's emotional and developmental needs, and overall family wellbeing, are best achieved when the service system supports diligently the ability of the family to meet the needs of their child, by involving families in the plan of care (Allen 1998; Neff 2003).
Background
Much of the literature concerning family‐centred care has originated from the United Kingdom (UK) and the USA, which are developed and culturally‐distinctive (predominately Anglo‐Saxon) societies (Irlam 2002). In less developed countries with fewer technological, economic and human resources, specific information about the psychosocial care of children in hospital is limited (Irlam 2002; Shields 2001a). Shields (Shields 2001b) found that in some developing countries, parents were encouraged to stay with their hospitalised child only if it fitted with hospital rules. Stanford (Stanford 1986) reported that in Central America where children's health is poor, some hospitals allowed parents to stay when their child was acutely ill, while some restricted parental visiting to one hour per day. These restrictions on parental visiting were thought to be the result of space limitations and lack of facilities rather than a philosophical objection to parents being present.
Family‐centred care in high‐income countries has been explored as care that is led by parents, with the nurse acting as a consultant, encouraging open and honest dialogue with the family (Hutchfield 1999; Irlam 2002). The family is acknowledged as expert in the care of their child, and the perspectives and information provided by the family have been described as important to clinical decision‐making (Irlam 2002; Neff 2003; Webster 1999).
In the UK, the importance of promoting the role of families in the care of the hospitalised child has been acknowledged (DOH 2003). A number of related terms has been used to describe the attributes of family‐centred care (Hutchfield 1999); these include partnership‐in‐care (Coyne 1996), parental involvement (Hurst 1993), nurse‐parent partnership (Hill 1996), parental participation (K‐Hallstrom 1999, and care‐by‐parent (Costello 1998; Evans 1994).
In 1992, the Institute for Family‐Centered Care was established in the USA, taking over the role of the Association for the Care of Children's Health, whose task it had been to develop a nationwide program to enhance the implementation of a family‐centred approach to the care of infants, children, and adolescents. Much of the family‐centred care literature from the USA refers to the seminal work of Shelton (Shelton 1987), who developed a framework for offering family‐centred care to children. Within this framework, Shelton and colleagues delineated eight elements which characterise health services which are family‐centred (Trivette 1993). Subsequently, a ninth element was included (Johnson 1990). The nine elements of family‐centred care include:
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recognising the family as a constant in the child's life;
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facilitating parent‐professional collaboration at all levels of health care;
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honouring the racial, ethnic, cultural, and socio‐economic diversity of families;
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recognising family strengths and individuality and respecting different methods of coping;
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sharing complete and unbiased information with families on a continuous basis;
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encouraging and facilitating family‐to‐family support and networking;
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responding to child and family developmental needs as part of health care practices;
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adopting policies and practices that provide families with emotional and financial support; and
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designing health care that is flexible, culturally competent, and responsive to family needs.
According to the Institute for Family‐Centered Care's definition:
"Family‐centered care is an approach to the planning, delivery, and evaluation of health care that is grounded in mutually beneficial partnerships among health care providers, patients, and families. It redefines the relationships between and among consumers and health providers. Family‐centered practitioners recognise the vital role that families play in ensuring the health and well being of infants, children, adolescents, and family members of all ages. They acknowledge that emotional, social, and developmental supports are integral components of health care. They promote the health and well being of individuals and families and restore dignity and control to them. Family‐centered care is an approach to health care that shapes policies, programs, facility design, and staff day‐to‐day interactions. It leads to better health outcomes and wiser allocation of resources, and greater patient and family satisfaction" (Webster 1999).
It has been suggested that to practice in a family‐centred manner requires a shift in the orientation of health services from a professionally‐centred model to a collaborative model which recognises family involvement as central to their child's care. Within this view, the healthcare provider is an equal partner and facilitator of care, and families are invited to participate actively in the decision‐making, planning and provision of their child's care to the extent they choose (Ahmann 1998).
Potential advantages and disadvantages of family‐centred care
There is a range of potential benefits and difficulties associated with the provision of family‐centred care. For instance, in one study, family‐centred changes to the neonatal transitional care facility were associated with favourable clinical outcomes. These changes included converting three neonatal multi‐bed areas in the stepdown nursery into 12 private living/sleeping units for families to reside with, and learn to care for, their infants on a daily basis. A small group of neonatal nurses provided consistency in caregiving, and daily interdisciplinary care rounds occurred at the bedside with parents participating in care decisions. Outcomes included a decreased length of hospital stay, fewer rehospitalisations, reduced use of the emergency department and reduced parental anxiety (Forsythe 1998).
However, researchers have also reported challenges when trying to implement changes which would result in meaningful family involvement in the care of their hospitalised child. Healthcare providers have reported a lack of adequate education in relation to understanding and implementing the concept of family‐centred care in a practice situation, as well a lack of a shared understanding of, and commitment to, family‐centred care among all health professionals and families (Bruce 1997; Bruce 2002). In addition, the hospitalisation of a child, whether planned or unplanned, is stressful for even the most well‐organised and functional family (Melnyk 2000). The significant adjustments to both parent and healthcare provider roles when a child is hospitalised may result in understandable levels of stress (Callery 1997). Potential disadvantages of family‐centred care may be that families feel that they are expected to provide input into the care of their child beyond their expectations or capabilities, or are given more information than either the child or the family is ready to hear. This may cause additional stress or anxiety for both the parents and child.
Other models of health care for children
Other common paradigms underlying the provision of healthcare services for children include professionally‐led models, where the health care provider plays a major role in assessing and formulating a plan of care, based upon the perceived needs of the child and/or family. These professionally‐led models have been further classified, depending on the primary focus of the model, into the standard model and professionally‐centred model of health care (Ahmann 1998; Dunst 1991).
Standard model
In the medical or standard model of health care, the healthcare worker plans care around the child's illness and treatment needs, and the family is generally expected to comply with treatment recommendations (Ahmann 1998).
Professionally‐centred model
The professionally‐centred model includes both the child‐focussed and family‐focussed models. In the child‐focused model, the needs of the child are considered in the plan of care (eg. presurgical preparation) but, as with the standard model of care, health providers develop a plan of care according to the perceived needs of the child. In the family‐focussed model the health provider's assessment moves beyond the child to consider ways to best help both the family and child (Ahmann 1998). The common theme underlying most professionally‐centred models of care is that the health provider is seen as the expert who determines the needs of the child/family from their own perspective, as opposed to the family's perspective (Dunst 1991).
Potential advantages and disadvantages of professionally‐centred care
Although there is a lack of published data about the advantages and disadvantages of professionally‐centred models of care, the perceived advantages may be similar to family‐centred care, since the ultimate goal for both models is to optimise the healthcare experience and outcomes for hospitalised children and their families. A potential disadvantage of professionally‐centred models may be that the intervention does not meet the needs of the child or parents, because it is based on what the health professional perceives the need to be, rather than the actual needs of the child and family. This could result in harmful outcomes such as increased stress, anxiety and confusion.
Implementation of family‐centred care
It is expected that the development, implementation and outcomes of family‐centred models of care, may differ according to the population and setting in which the models are applied. For example, the needs and outcomes for families of high‐risk neonates who experience long hospital stays may differ from those of families of a previously healthy young child who is admitted for a treatment procedure, or of a child with a chronic illness who may have repeated hospitalisations. Also, older children may have a greater awareness and understanding of the reasons for their hospitalisation. and therefore models of care may reflect increased participation of the child in their hospital care.
However, even if the processes of family‐centred care are seen as making a difference and advantageous in their own right, reliable reassurance that they result in more good than harm should be sought. Currently there is little systematic information on how these principles have underpinned changes in healthcare practice and service delivery when a child is hospitalised, and the effect of family‐centred approaches on child and family outcomes and health service delivery (Allen 1998).
This review examines the effects of models of care which aim to promote family‐centred care when a child is hospitalised, on family/child health outcomes, staff‐client relationships and health service outcomes.
We draw readers' attention to a companion Cochrane systematic review: Interventions (non‐pharmacological) for preparing children and adolescents for hospital care (Prictor 2004).
Objectives
The primary objective of this review is to assess the effects of family‐centred models of care for hospitalised children when compared to standard or professionally‐centred models of care, on child, family and health service outcomes.
A secondary objective of this review is to assess whether the effects of family‐centred models of care for hospitalised children, when compared to standard or professionally‐centred models, differ according to:
(1) Degree of family‐centredness
High degree of family‐centred care, ie. scores for family‐centredness of 70 or greater (see Methods section for description of ratings).
(2) Population of children:
-
premature infants being cared for in a neonatal intensive care or special care nursery;
-
children admitted to hospital in the period from discharge after birth episode to 5 years of age;
-
children admitted to hospital from 6 to 12 years of age;
-
children admitted to hospital for surgery;
-
children with a chronic health condition (ie. a physical, mental, emotional, behavioural, or developmental disorder expected to last 12 months or longer, or having sequelae that last 12 months or longer, and requiring treatment and/or monitoring (Gay 1997).
Due to the complex nature of family‐centred care and the heterogeneity of possible interventions, it is difficult to pre‐specify which comparisons will be possible. Therefore, a decision about comparison groups will be reached through consensus between the review team and the Cochrane Consumers and Communication Review Group editorial team after the final search is completed. Depending on the outcome, it may be necessary to revise the protocol.
Methods
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) or quasi‐randomised controlled trials including cluster randomised trials and controlled clinical trials (CCTs), controlled before and after studies (CBAs), in which family‐centred care models are compared with professionally‐centred models of care.
Types of participants
Child/children: throughout this review, the term 'child' or 'children' is used to include all newborn infants, babies and children up to the age of 12 years being cared for in hospital; and all parts of hospitals that provide a service to children. The definitions of childhood can vary, and age limits are arbitrary. For the purpose of this review the National Library of Medicine's medical subject headings (NLM 2004) were used to define the age cutoff of 12 years.
Families: throughout the review the following definition of the family will be applied:
The family is a basic social unit having as its nucleus two or more persons, irrespective of age, in which each of the following conditions are present:
a) the members are related by blood, or marriage, or adoption, or by a contract which is either explicit or implied;
b) the members communicate with each other in terms of defined social roles such as mother, father, wife, husband, daughter, son, brother, sister, grandfather, grandmother, uncle, aunt; and
c) they adopt or create and maintain common customs and traditions.
This definition has been modified from Nixon's original definition (Nixon 1988) to allow for inclusion of significant others who do not usually cohabit with the family.
Health care providers involved in caring for hospitalised children
Types of interventions
Any healthcare intervention that aims to promote the family‐centred model of care during a child's hospitalisation. Only studies that provide clear evidence that the family and/or child were actively involved in the planning and/or delivery of healthcare during the child's hospitalisation will be considered for inclusion in this review. For the purposes of the review, the minimum criteria for active involvement will include evidence of collaboration between health carers and the family and/or child in the planning and/or delivery of care as soon as possible after admission or during the preadmission period. Included studies must also compare family‐centred models with professionally‐centred models or standard models of care.
Types of interventions could include:
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environmental interventions, as evidenced by: collaboration with the family and/or child in the design or redevelopment of facilities to provide an environment that maximises parental involvement and enhances child recovery and/or convalescence; care‐by‐parent units; privacy areas;
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family‐centred policies, which may include: open visiting hours for siblings or extended family; parent participation in their child's care to the extent they choose (for example, feeding, bathing); parental presence during healthcare procedures such as routine examinations, anaesthetic induction, venipuncture and post‐anaesthetic recovery; bereavement team/protocols;
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communication interventions, which could include: parental presence and participation at daily interdisciplinary ward round; family conferences to plan future care; developing collaborative care pathways where both parent and/or child and health carer document issues and progress; reorganisation of health care to provide continuity of caregiver (such as primary nursing); shared medical records; local hospital‐based interpreters;
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educational interventions, which could include: structured educational sessions for parents of technologically‐dependant children; continuing education programs to equip staff to provide care within a family‐centred framework; preadmission programs; and
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family support interventions, such as: flexible charging schemes for poor families; referrals to other hospital or community services (such as social workers, chaplains, patient representatives, mental health professionals, home health care, rehabilitation services); facilitating parent‐to‐parent support.
We will exclude studies where there is no clear evidence of collaboration between the family and/or child and healthcare provider in the planning and/or delivery of care.
Types of outcome measures
A number of processes and outcomes might be affected by models of care which aim to incorporate families in the decision making, planning, provision and evaluation of care when their child is hospitalised. Where possible, the use of validated research tools to measure satisfaction with care and psychological outcomes will be considered when assessing study quality.
Child
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Psychosocial outcomes including psychological health (such as anxiety, confidence, sense of control, coping, adjustment, stress, upset, crying, insomnia, fears, behavioural regression), attitudes towards caregivers and attitudes towards rehospitilisation.
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Behaviour (such as level of co‐operation, compliance with care, and appetite).
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Physical health including physiological measures such as blood pressure and pulse rate; pain assessment or control such as use of medication or other means to reduce pain; length of hospital admission, readmission.
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Developmental outcomes including weight gain, developmental milestones.
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Knowledge and understanding including knowledge of condition, treatment, knowledge about personnel or procedure.
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Satisfaction: for example, with involvement in decision making, with level of communication.
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Attitudes: for example, views of cultural appropriateness, flexibility.
Parent
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Psychological health (for example, stress, anxiety, perceptions of coping, sense of control) and satisfaction (for example, involvement in decision making, level of communication).
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Attitudes (such as complaints, evaluations of cultural appropriateness, flexibility and responsiveness of the intervention).
Staff
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Psychological health (for example, stress, responsiveness to patient's needs, confidence) and satisfaction (for example with the intervention, with care provided, with the level of education provided about family‐centred care).
Health Services
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Health‐service provision outcomes, such as staffing requirements, costs of the intervention, time needed for the intervention, use of other hospital department services, litigation claims.
All adverse outcomes, such as an increase in anxiety after receiving the intervention, will be recorded where data are available. Outcomes measured by non‐validated tools will be included and this will be clearly highlighted in the results and discussion section of the review.
Search methods for identification of studies
This review will draw on the search strategy developed for the Cochrane Consumer and Communication Review Group and an additional search strategy developed on critical text words and including relevant study designs.
We will search:
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MEDLINE (1966 to 2004);
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The Cochrane Central Register of Controlled Trials (CENTRAL), (The Cochrane Library, Issue 2, 2004);
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CINAHL (1982 to 2004);
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PsycINFO (1972 to 2004);
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ERIC (1982 to 2004);
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Sociological Abstracts (1963 to 2004);
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Social Work Abstracts (1977 to 2004); and
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AMI Australian Medical Index (1966 to 2004).
We will cross reference relevant literature including identified trials, existing review articles, published conference and symposia proceedings, dissertations, hospital policy documents and other key informants. There will be no limitation by publication language.
We will also search the Web of Science citation database (electronic resource: Institute for Scientific Information; including Science Citation Index Expanded, Social Sciences Citation Index, Arts & Humanities Citation Index 1970 to present). Search strategies were tailored to each database. The strategy for MEDLINE [online via Pub Med] is presented below as an example:
1 randomized controlled trial.pt
2 randomi?ed control* trial* tw
3 controlled clinical trial. pt.
4 random* allocat* tw
5 double blind method (MeSH)
6 single‐blind method (MeSH)
7 or/1‐6
8 clinical trial.pt.
9 exp clinical trials (MeSH)
10 (clinic* near trial*).tw.
11 ((singl* or doubl* or trebl* or tripl*) near (blind* or mask*)).tw.
12 placebos (MeSH)
13 placebo*.tw.
14 random*.tw.
15 research design (MeSH)
16 or/8‐15
17 comparative study (MeSH)
18 exp evaluation studies (MeSH)
19 follow up studies (MeSH)
20 prospective studies (MeSH)
21 (control* or prospectiv* or volunteer*).tw.
22 (time adj series).tw.
23 pre test or pretest or post test or posttest. tw.
24 or/17‐23
25 animal not (human and animal) (MeSH)
26 7 or 16 or 24
27 26 not 25
28 exp child (MeSH)
29 child* tw
30 exp pediatric (MeSH)
31 p?ediatric* tw
32 exp infant (MeSH)
33 perinat* or neonat* or newborn or new born or infant* or baby or babies or toddler* tw
34 preterm or prematu* tw
35 schoolage or school age tw
36 or /28‐35
37 hospitali?ed or hospitali?ation tw
38 child‐hospitalized (MeSH)
39 36 and 37
40 38 or 39
41 patient centred care (MeSH)
42 caregivers (MeSH)
43 exp Interpersonal Relations (MeSH)
44 Family cent?red care tw
45 patient cent?red care tw
46 (child* or famil*) near focus*
47 exp Maternal Child Nursing (MeSH)
48 exp Pediatric Nursing (MeSH)
49 Family nursing (MeSH)
50 Models‐ Nursing (MeSH)
51 'partnership in care' or 'partners in care' or 'involvement in care' or 'share care'
52 'care by parent' or 'care‐by‐parent'
53 family or families or parent* or mother* or father or care* or mutual tw
54 partners* or participat* or presence or involv* or decision* or communicat* or negotiat* or collaborat* or visit* tw
55 53 near2 54
56 55 or 41‐52
57 40 and 56
58 27 and 57
Data collection and analysis
We will use standard methods for Cochrane reviews, as described in the Cochrane Reviewers' Handbook (Clarke 2003).
Search and selection of trials
Two reviewers (Jan Pratt and Leigh Davis) will undertake the literature search independently and compare results. Two reviewers will independently screen the titles and abstracts of studies identified by the search, according to the inclusion criteria of the review, including an assessment of the intervention in terms of the degree of family‐centredness, as described below. Those studies which clearly do not fulfil inclusion criteria will be discarded. We will retrieve potentially‐relevant articles for full‐text assessment. Discrepancies will be resolved through discussion with all reviewers. We will give reasons for exclusion of any studies.
Assessment of the intervention
In order to assess relevant studies for the degree of family‐centredness, this review will utilise a modified rating scale based on that developed by Trivette, Dunst and colleagues (Trivette 1993). These authors used the 9 elements of family‐centred care, as described by the Association for the Care of Children's Health, to develop 13 evaluation items that describe the features of family‐centred care. The 9 Association for the Care of Children's Health elements and the 13 corresponding sub‐elements are presented in Table 1. These sub‐elements are further grouped into three cluster groups (ie. Cluster 1: family as a constant; Cluster 2: culturally responsive; Cluster 3: supporting family individuality) derived from an original cluster analysis by Trivette, Dunst and colleagues (Trivette 1993). See Table 2. The clusters will be used to help describe the model of family‐centred care in individual trials.
| Elements of FCC | Evaluative Items |
| Recognising the family as a constant in the child's life | 1. Family as the principle context for the provision of a child's health care |
| Facilitating parent‐professional collaboration at all levels of health care | 2. Promoting and utilizing parent‐professional collaboration and partnerships |
| Honouring the racial, ethnic, cultural, and socioeconomic diversity of families | 3. Respect for family diversity |
| Recognizing family strengths and individuality and respecting different methods of coping | 4. Recognising the strengths and capabilities of families |
| 5. Recognising different methods of family coping | |
| Sharing complete and unbiased information with families on a continuous basis | 6. Complete sharing of all relevant information with families |
| Encouraging and facilitating family‐to‐family support and networking | 7.Promoting parent‐to‐parent and family‐to‐family support |
| Responding to child and family developmental needs as part of health care practices | 8. Attention to the developmental needs of children and families as part of health care delivery |
| Adopting policies and practices that provide families with emotional and financial support | 9. Recognising and responding to family emotional needs |
| 10. Recognising and responding to family financial needs | |
| Designing health care that is flexible, culturally competent, and responsive to family needs | 11. Flexible delivery of health care to children and their families |
| 12. Culturally‐competent delivery of health care | |
| 13. Recognising and responding to family‐identified needs |
| RATING | 0 | 1 | 2 | 3 | 4 |
| Cluster 1: Family as a constant | |||||
| Family as a constant in child's life | |||||
| Recognising family strengths | |||||
| Parent/professional collaboration | |||||
| Needs‐based family support | |||||
| Flexible provision of health care | |||||
| Sharing information with families | |||||
| Cluster 2: Culturally responsive | |||||
| Culturally‐competent health care | |||||
| Respecting family diversity | |||||
| Providing financial support | |||||
| Cluster 3: Supporting family individuality | |||||
| Respecting family coping methods | |||||
| Providing emotional support | |||||
| Family‐to‐family support | |||||
| Attending to the developmental needs of children and families | |||||
| TOTAL SCORE |
A rating of (0 to4) will be applied to each of the 13 sub‐elements of family‐centred care:
0. Article includes no evidence that the intervention either implicitly or explicitly was based upon the elements of family‐centred care.
1. Article includes a minimal amount of implicit evidence that the intervention was based upon the elements of family‐centred care.
2. Article includes numerous instances of implicit evidence that the intervention was based upon the elements of family‐centred care.
3. Article includes a minimal amount of explicit evidence that the intervention was based upon the elements of family‐centred care.
4. Article includes numerous instances of explicit evidence that the intervention was based upon the elements of family‐centred care.
An element of family‐centred care will be considered as implicitly addressed if it could be inferred that the author(s) descriptions, arguments etc. were consistent with the intent of the elements of family‐centred care, whereas if an element of family‐centred care was clearly stated and distinctly expressed it ought to underscore health practice and was therefore considered explicitly addressed or endorsed (Trivette 1993).
Independently, each reviewer will score the evaluation items from 0 to 4 for each study, and final scores will be resolved by consensus among reviewers. The scores will be added together to give an overall rating of the intensity of family‐centredness. The maximum possible score will therefore be 52, and scores of 42 (or 80% of total score) or greater will indicate a high degree of family‐centredness. The results of the study rating will be compared amongst reviewers and also by an independent expert in the field. Agreement will be assessed using Kappa statistic.
Study quality assessment
We will assess the methodological quality of the trials included in this review using the following criteria (Clarke 2003; EPOC 2002). Authors will be contacted for clarification as required.
RCTs and CCTs
Random allocation to intervention and control group will be graded as:
(A) adequate;
(B) inadequate;
(C) unclear.
Adequacy of concealment of allocation to experimental or control groups will be graded as:
(A) adequate;
(B) inadequate or not used;
(C) unclear.
Completeness of follow‐up will be graded as:
(A) <20% of participants excluded;
(B) >20% of participants excluded;
(C) unclear.
If completeness of follow‐up is graded as (B) for all outcomes, then the study will be excluded.
Blinding of assessment of outcome will be graded as:
(A) blinded, or not blinded but minimal risk of bias;
(B) high likelihood of bias;
(C) unclear.
Protection against contamination from intervention to control group will be graded as:
(A) allocation by community, institution or practice: unlikely control group received intervention;
(B) moderate to high risk that control group received intervention;
(C) unclear.
We will exclude studies with a (B) rating for protection against contamination.
Allocation to experimental or control groups will be graded as:
(A) definitely assigned prospectively;
(B) not assigned prospectively;
(C) unclear.
If adequacy of concealment is graded as (B), the study will be considered according to the CBA criteria.
Protection against unit of analysis error will be graded as:
(A) adjustment adequate or not required;
(B) adjustment inadequate;
(C) unclear.
If protection against error is graded as (B) or (C) the study authors will be contacted for clarification and to explore the potential for making required adjustment.
For Controlled Before and After studies (CBAs) the following quality assessment will be undertaken:
Contemporaneous data collection will be graded as:
(A) done for both pre and post intervention periods;
(B) not done for both pre and post intervention periods;
(C) unclear.
If contemporaneous data collection is graded as (B), the study will be excluded.
Appropriate choice of control site will be graded as:
(A) if both study and control sites are comparable;
(B) if study and control sites are not comparable;
(C) unclear.
If choice of control site is graded as (B), the study will be excluded.
Completeness of follow‐up will be graded as:
(A) <20% of participants excluded;
(B) >20% of participants excluded;
(C) unclear.
If completeness of follow‐up is graded as (B) for all outcomes, then the study will be excluded.
Blinding of assessment of outcome will be graded as:
(A) blinded or not blinded but minimal risk of bias;
(B) high likelihood of bias;
(C) unclear.
Protection against contamination from intervention to control group will be graded as:
(A) allocation by community, institution or practice: unlikely control group received intervention;
(B) moderate to high risk that control group received intervention;
(C) unclear.
We will define RCTs with adequate allocation concealment and less than 20% post randomisation exclusions as studies of high methodological quality.
Data collection and analysis
For included studies, data will be extracted by three reviewers independently (Linda Shields, Jan Pratt and Leigh Davis). We will resolve discrepancies by discussion and consensus. On completion of the search and data extraction, we will undertake a structured narrative presentation of the studies, based on the categorisation of the interventions listed under 'Types of Intervention', ie. family‐centred models and professionally‐centred models of care. Depending on the number and breadth of the studies, further stratification (for example, by the cluster elements of family‐centred care, and by age group) may be undertaken.
We will collect descriptive data on the authors, year of publication, setting, country, time span of the study, basis for calculated sample size, number of study participants, description of study participants, number of participants analysed, timing of data collection, and description of the intervention (particularly in terms of the nine elements of family‐centred care as discussed earlier).
Primary analyses will be based on 'intention to treat'. Authors will be contacted for missing data if necessary. Where validated instruments are available but not used to measure all study outcomes, these outcomes will be excluded. Also, we will exclude reported outcomes where there is >20% loss to follow‐up. Meta‐analysis will be conducted including homogenous randomised and quasi‐randomised trials only. Cluster randomised controlled trials will be analysed separately. CBAs will not be meta‐analysed but will be individually described.
Meta‐analysis will be conducted using the fixed and random effects model. Heterogeneity will be assessed using the Chi‐squared test of heterogeneity along with visual inspection of the graph. A significance level less than 0.10 will be interpreted as evidence of heterogeneity. Where heterogeneity is found, the reviewers will look for an explanation. If studies with heterogeneous results are found to be comparable the statistical synthesis of the results will be undertaken using a random effects model. Due to the potential heterogeneity of the studies which may be included in this review, studies in which clinical and/or statistical heterogeneity in the opinion of the reviewers would compromise the validity of the review, will not be combined in a meta‐analysis, and results of the individual trials only will be presented.
For continuous data, where outcomes have been measured in a similar way across studies, the weighted mean difference (WMD) and confidence intervals (CI) will be reported. Where studies have used different instruments to measure the same conceptual phenomenon (eg. satisfaction with care) the standardised mean difference (SMD) will be reported. In such cases, a cautious approach will be taken to combining results, and the rationale will be detailed.
In studies that report dichotomous data, the relative risk (RR) and CIs will be calculated and reported. The risk difference (RD) and number needed to treat (NNT) will be reported if appropriate.
Results will be presented for each comparison by the type of intervention and will include a description of the degree of family‐centredness.
Sensitivity analysis will be conducted to assess the impact of study quality on outcome, if studies of different quality are identified. Studies of high methodological quality, defined as RCTs with adequate allocation concealment and less than 20% post randomisation exclusions, will be included in this analysis.
Where sufficient data is available, subgroup analysis will be conducted by:
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degree of family‐centredness, ie. high degrees of family‐centredness (see Methods Section).
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populations of children:
‐ premature infants being cared for in a neonatal intensive care or special care nursery;
‐ children admitted to hospital in the period from discharge after birth episode to 5 years of age;
‐ children admitted to hospital from 6 to 12 years of age;
‐ children admitted to hospital for surgery;
‐ children with chronic health conditions.
Consumer participation
There are several organisations worldwide which are advocates for children and families who use health services. Contact has been made with the Australian Association for the Welfare of Child Health Inc, who have agreed to provide feedback on the protocol and the final review.
| Elements of FCC | Evaluative Items |
| Recognising the family as a constant in the child's life | 1. Family as the principle context for the provision of a child's health care |
| Facilitating parent‐professional collaboration at all levels of health care | 2. Promoting and utilizing parent‐professional collaboration and partnerships |
| Honouring the racial, ethnic, cultural, and socioeconomic diversity of families | 3. Respect for family diversity |
| Recognizing family strengths and individuality and respecting different methods of coping | 4. Recognising the strengths and capabilities of families |
| 5. Recognising different methods of family coping | |
| Sharing complete and unbiased information with families on a continuous basis | 6. Complete sharing of all relevant information with families |
| Encouraging and facilitating family‐to‐family support and networking | 7.Promoting parent‐to‐parent and family‐to‐family support |
| Responding to child and family developmental needs as part of health care practices | 8. Attention to the developmental needs of children and families as part of health care delivery |
| Adopting policies and practices that provide families with emotional and financial support | 9. Recognising and responding to family emotional needs |
| 10. Recognising and responding to family financial needs | |
| Designing health care that is flexible, culturally competent, and responsive to family needs | 11. Flexible delivery of health care to children and their families |
| 12. Culturally‐competent delivery of health care | |
| 13. Recognising and responding to family‐identified needs |
| RATING | 0 | 1 | 2 | 3 | 4 |
| Cluster 1: Family as a constant | |||||
| Family as a constant in child's life | |||||
| Recognising family strengths | |||||
| Parent/professional collaboration | |||||
| Needs‐based family support | |||||
| Flexible provision of health care | |||||
| Sharing information with families | |||||
| Cluster 2: Culturally responsive | |||||
| Culturally‐competent health care | |||||
| Respecting family diversity | |||||
| Providing financial support | |||||
| Cluster 3: Supporting family individuality | |||||
| Respecting family coping methods | |||||
| Providing emotional support | |||||
| Family‐to‐family support | |||||
| Attending to the developmental needs of children and families | |||||
| TOTAL SCORE |
