Paediatric Hospital Care (Canada) Protocol
Purpose of the PSP and background
The purpose of this protocol is to clearly set out the aims, objectives and commitments of the Paediatric Hospital Care Priority Setting Partnership (PSP) in line with James Lind Alliance (JLA) principles. The Protocol is a JLA requirement and will be published on the PSP’s page of the JLA website. The Steering Group will review the Protocol regularly and any updated version will be sent to the JLA.
The JLA is a non-profit making initiative, established in 2004. It brings patients, carers and clinicians together in PSPs. These PSPs identify and prioritise the evidence uncertainties, or ‘unanswered questions’, that they agree are the most important for research in their topic area. Traditionally PSPs have focused on uncertainties about the effects of treatments, but some PSPs have chosen to broaden their scope beyond that. The aim of a PSP is to help ensure that those who fund health research are aware of what really matters to patients, carers and clinicians. The National Institute for Health Research (NIHR – www.nihr.ac.uk) coordinates the infrastructure of the JLA to oversee the processes for PSPs, based at the NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton.
Paediatric Hospital Care Priority Setting Partnership
Optimal care of hospitalized children is essential to improve health outcomes. Admission to hospital can be a vulnerable period for children and families due to both the physical effects of serious illness and the psychologic effects of the illness and hospitalization. There are also negative economic implications including impacts on families due to work absences and the indirect costs of hospitalization (e.g. transportation). The largest population of children cared for in hospital are those with medical conditions managed in general paediatric inpatient units (GPIUs). In Canadian pediatric health centers, conditions cared for in GPIUs are considered to be the most common conditions leading to hospitalization. Children admitted to GPIUs may be previously healthy and be hospitalized for acute, common illness (e.g. gastroenteritis) or the first presentation of a chronic condition (e.g. epilepsy). They may also be children with a chronic disease (e.g. asthma) or medical complexity (e.g. cerebral palsy and gastrostomy feeding) who are hospitalized for an acute, common illness or exacerbation of their chronic disease.
Children admitted to GPIUs may not receive optimal health care due to a lack of high-quality research. We recently established the Canadian Pediatric Inpatient Research Network (PIRN), which is a hospital-based research network focused on generating scientific knowledge to improve the outcomes of hospitalized children in GPIUs through the conduct of patient-oriented research. PIRN includes hospital sites affiliated with all 15 academic children’s hospitals across Canada as well as several large community hospitals. To guide future research priorities in paediatric hospital care and for PIRN, we aim to identify GPIU clinical management questions that are important to patients (i.e. children and youth), carers (i.e. parents, family and caregivers), and healthcare professionals (HCPs).
Aims, objectives and scope of the PSP
The aim of the Paediatric Hospital Care PSP is to identify the unanswered questions about pediatric hospital care in general paediatric inpatient units (GPIUs) from patient, carer and clinical perspectives and then prioritise those that patients, carers and clinicians agree are the most important for research to address.
The objectives of the PSP are to:
- work with patients, carers and clinicians to identify uncertainties about pediatric medical conditions managed in GPIUs
- agree by consensus a prioritised list of those uncertainties, for research
- publicise the results of the PSP and process
- take the results to research commissioning bodies to be considered for funding.
Scope of the PSP
The Paediatric Hospital Care PSP will cover clinical management questions relevant to the care of children (age between 0 and 18 years) hospitalized in a GPIU. Clinical management broadly refers to the diagnosis and treatment of conditions, which includes processes of care (e.g. how to promote better sleep in hospitalized children) and specific conditions (e.g. blood tests to diagnose infection, interventions for asthma care).
GPIUs may be located either on a hospital ward in a children’s hospital or a general community hospital. While there is variation between Canadian hospitals regarding the types of conditions cared for in GPIUs, the PSP will focus on and include children with conditions where the management is led by general pediatricians. For example, children that are cared for in a GPIUs may be previously healthy and be hospitalized for acute, common illness (e.g. gastroenteritis) or the first presentation of a chronic condition (e.g. epilepsy). They may also be children with a chronic disease (e.g. asthma) or medical complexity (e.g. cerebral palsy and gastrostomy feeding) who are hospitalized for an acute, common illness or exacerbation of their chronic disease. The scope will include children with technology-dependent conditions.
Given the breadth of childhood mental health problems, we will exclude questions related to the management of known mental health problems in-hospital (e.g. depression) which would require specialist input (e.g. psychiatry). For example, questions related to diagnostic tests (e.g. blood tests, head imaging) of children who present with new onset hallucinations would be included, as these patients are generally cared for in a GPIU, but questions focused on the types of treatments used for hospitalized children with schizophrenia would be excluded. We will exclude questions related to chronic or pre-existing mental health problems of parents and caregivers.
As the scope is focused on care in a GPIU, we will exclude children who are seen in specialized settings of care, including the paediatric intensive care unit (PICU), the neonatal intensive care unit (NICU), medical subspecialty units (e.g. oncology), psychiatric, and surgical inpatient units. Similarly, we will exclude questions related to etiology or prognosis, and uncertainties related to healthcare organization and/or healthcare delivery (e.g. structure of inpatient unit, or staffing levels). We will also exclude uncertainties related to children who receive treatments outside of Canada.
Given the range of conditions, the scope will be further refined as needed by the Steering Group as the PSP progresses. The Steering Group is responsible for discussing what implications the scope of the PSP will have for the evidence-checking stage of the process. Resources and expertise will be put in place to do this evidence checking.
The Steering Group
The Steering Group includes membership of patients and carers and clinicians, as individuals or representatives from a relevant group.
The Paediatric Hospital Care PSP will be led and managed by a Steering Group involving the following:
- Francine Buchanan, Co-Chair of the SickKids Research Family Advisory Counsel
- Michelle Quinlan, Co-Chair Children’s Hospital of Eastern Ontario (CHEO) – Research Institute Family Leader Program Coordinator
- Shelley Frappier, Parent of a child who was hospitalized in a GPIU
- Kim De Castris-Garcia, Parent of a child who was hospitalized in a GPIU
- Mairead Green, Young person who was hospitalized in a GPIU
General Paediatric representatives
- Sanjay Mahant, Academic General Paediatrician, Hospital for Sick Children
- Ann Bayliss, Community General Paediatrician, Trillium Health Partners
- Karen Breen-Reid, Registered Nurse and Manager Interprofessional Education, Hospital for Sick Children
- Aubrey Sozer, Registered Nurse and Interim Interprofessional Education Specialist for Paediatric Medicine, Hospital for Sick Children
Co-Chair of the Steering Group
- Peter Gill, Academic General Pediatrician, Hospital for Sick Children
James Lind Alliance Adviser and Co-Chair of the Steering Group:
- Katherine Cowan, Senior Advisor to the JLA
PSP Project Coordinator
- Dana Arafeh, Hospital for Sick Children
The Steering Group will agree the resources, including time and expertise that they will be able to contribute to each stage of the process, with input and advice from the JLA.
Organisations and individuals will be invited to be involved with the PSP as partners. Partners are organisations or groups who will commit to supporting the PSP, promoting the process and encouraging their represented groups or members to participate. Organisations which can reach and advocate for these groups will be invited to become involved in the PSP. Partners represent the following groups:
- people who have had conditions that required hospitalization in the general paediatric inpatient unit
- carers of people who have been hospitalized in a general paediatric inpatient unit
- medical doctors, nurses and allied health care professionals with clinical experience caring for hospitalized children in a general paediatric inpatient unit
It is important that all organisations, which can reach and advocate for these groups should be invited to become involved in the PSP. The JLA Adviser will take responsibility for ensuring the various stakeholder groups are able to contribute equally to the process.
Some organisations may be judged by the JLA or the Steering Group to have conflicts of interest. These may be perceived to potentially cause unacceptable bias as a member of the Steering Group. As this is likely to affect the ultimate findings of the PSP, those organisations will not be invited to participate. It is possible, however, that interested parties may participate in a purely observational capacity when the Steering Group considers it may be helpful.
The methods the PSP will use
This section describes a schedule of proposed steps through which the PSP aims to meet its objectives. The process is iterative and dependent on the active participation and contribution of different groups. The methods used in any step will be agreed through consultation between the Steering Group members, guided by the PSP’s aims and objectives. More details of the method are in the Guidebook section of the JLA website at www.jla.nihr.ac.uk where examples of the work of other JLA PSPs can be seen.
Step 1: Identification and invitation of potential partners
Potential partner organisations will be identified through a process of peer knowledge and consultation, through the Steering Group members’ networks. Potential partners will be contacted and informed of the establishment and aims of the Pediatric Hospital Care PSP.
Step 2: Awareness raising
PSPs will need to raise awareness of their proposed activity among their patient, carer and clinician communities, in order to secure support and participation. Depending on budget, this may be done by a face-to-face meeting, or there may be other ways in which the process can be launched, e.g. via social media. It may be carried out as part of steps 1 and/or 3. The Steering Group should advise on when to do this. Awareness raising has several key objectives:
- to present the proposed plan for the PSP
- to generate support for the process
- to encourage participation in the process
- to initiate discussion, answer questions and address concerns.
Step 3: Identifying evidence uncertainties
The Paediatric Hospital Care PSP will carry out a consultation to gather uncertainties about clinical management from patients, carers and clinicians. The Steering Group will develop an online questionnaire in Research Electronic Data Capture (REDCap), a secure web-based application, to identify unanswered questions about paediatric hospital care in GPIUs. The questionnaire will include a section on demographic, an open-ended statement asking participants to identify questions about the care in GPIUs, and may include questions focused on specific topics previously identified as important (e.g. HCP-patient/carer communication). The questionnaire will be pilot tested and refined, and will be approved by the Steering Group before it is broadly disseminated through strategic partners. The survey will remain open for 3 months and will be monitored for diversity. We will also have limited printed copies of the questionnaire available with free return postage.
We aim to obtain a diverse range of responses based on geography, age, sex/gender, health state of child/youth (i.e. healthy, chronic illness, medical complexity), ethnicity and language (survey will be translated into French). We will also target vulnerable groups, including indigenous, non-native English speakers and high social risk groups. In order to ensure broad reach of all communities including marginalised populations, multiple recruitment approaches will be used to ensure diversity in those who are participating. The Paediatric Hospital Care PSP will be advertised through a website, social media, posters as well as flyers which will be circulated through well-known distribution lists and through partner organisations.
Existing sources of information about clinical management uncertainties will also be searched by examining published systematic reviews, clinical guidelines, protocols and on-going study registers.
Step 4: Refining questions and uncertainties
The consultation process will produce ‘raw’ questions and comments indicating patients’, carers’ and clinicians’ areas of uncertainty. These raw questions will be categorised and refined by the PSP Project Coordinator into summary questions which are clear, addressable by research, and understandable to all. Similar or duplicate questions will be combined where appropriate. Out-of-scope and ‘answered’ submissions will be compiled separately. The Steering Group will have oversight of this process to ensure that the raw data is being interpreted appropriately and that the summary questions are being worded in a way that is understandable to all audiences. The JLA Adviser will observe to ensure accountability and transparency. The Steering Group will target 40-50 summary questions.
The summary questions will then be checked against evidence to determine whether they have already been answered by research. This will be done by an Information Specialist, who will complete the JLA Question Verification Form, which clearly describes the process used to verify the uncertainty of the questions, before starting prioritisation. The Question Verification Form includes details of the types and sources of evidence used to check uncertainty. We will work with an experienced librarian to search MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials to look for relevant studies. The Question Verification Form should be published on the JLA website as soon as it has been agreed to enable researchers and other stakeholders to understand how the PSP has decided that its questions are unanswered, and any limitations of this.
Questions will be considered unanswered (i.e. ‘true uncertainties’) if there is no systematic review, if a recent systematic review indicated insufficient evidence, or if there is insufficient evidence outlined in position statements from the Canadian Paediatric Society and American Academy of Pediatrics. Questions which can be resolved by reference to existing literature will classified as ‘answerable questions’ and dealt with separately. The Steering Group will consider how it will deal with submitted questions that have been answered, and questions that are out of scope.
Step 5: Prioritisation – interim and final stages
The aim of the final stage of the PSP is to prioritise through consensus the identified uncertainties about conditions cared for in GPIUs. The final step will involve input from patients, carers and clinicians. The JLA encourages PSPs to involve as wide a range of people as possible, including those who did and did not contribute to the first consultation. The format of the final prioritization process will be agreed by members of the Steering Group, which usually consists of two stages:
1. Interim prioritisation is the stage where the long list of questions is reduced to a shorter list that can be taken to the final priority setting workshop. This is aimed at a wide audience, and is done using similar methods to the first consultation. With the JLA’s guidance, the Steering Group will agree the method and consider how best to reach and engage patients, carers and clinicians in the process. The most highly ranked questions (around 25) will be taken to a final priority setting workshop. Where the interim prioritisation does not produce a clear ranking or cut off point, the Steering Group will decide which questions are taken forwards to the final prioritisation.
2. The final priority setting stage is generally a one-day workshop facilitated by the JLA. With guidance from the JLA and input from the Steering Group, up to 30 patients, carers and clinicians will be recruited to participate in a day of discussion and ranking, to determine the top 10 questions for research. All participants will declare their interests. The Steering Group will advise on any adaptations needed to ensure that the process is inclusive and accessible. The workshop will be led by JLA Advisor Katherine Cowan and use a modified nominal group technique, a well-established structured, multistep facilitated group meeting technique. Two additional JLA facilitators will manage the discussions, to ensure balanced contributions from carers and healthcare professionals.
Dissemination of results
Findings and research
The findings of the Paediatric Hospital Care PSP will be reported to funding and research agenda setting organisations such as the Canadian Institutes for Health Research, the Canadian Pediatric Society, Children’s Healthcare Canada, and the Maternal Infant Child and Youth Research Network. We will disseminate the unanswered questions through our knowledge users and partners, and by posting the results on the JLA website. The Steering Group will determine how best to communicate the results and who will take responsibility for this. Steering Group members and partners are encouraged to develop the prioritised uncertainties into research questions, and to work to establish the research needs of those unanswered questions to use when approaching potential funders, or when allocating funding for research themselves, if applicable.
As well as alerting funders, partners and Steering Group members are encouraged to publish the findings of the Pediatric Hospital Care PSP using both internal and external communication mechanisms. The Steering Group may capture and publicise the results through descriptive reports of the process itself in plain language. This exercise will be distinct from the production of an open-access academic paper, which will also be completed. However, production of an academic paper should not take precedence over publicising the final results. Additional potential outputs include infographics, conference presentations and videos for social media.
The JLA encourages PSPs to report back about any activities that have come about because of the PSP, including funded research. Please send any details to firstname.lastname@example.org.
Agreement of the Steering Group
The Paediatric Hospital Care PSP Steering Group agreed the content and direction of this Protocol on 28 May 2020.