Background and objectives
Morbidity and mortality are relatively common in very young children. Health care and supportive technology have improved, but the allocation of these resources in this age group may necessitate difficult choices and decisions. Cost-effectiveness analysis (CEA) can help guide these decisions, and thus measuring Health-Related Quality of Life (HRQoL) is becoming more important. However, the components of HRQoL are likely to be infant and young child specific. The goal of this study was to create a bank of items to help inform the possible development of a new proxy report instrument.
A review of the literature was conducted in order to define the concepts, generate items, and identify measures that could be used as a starting point of reference. The items derived from the cognitive interviews and systematic review were then pruned by HRQoL and paediatric experts over two rounds of a Delphi study.
The greatest need for a new HRQoL measure, according to the various sources, was in the 0-3-year age group. The literature-identified item pool contained 36 items, which were increased to 53 items following the cognitive interviews. The Delphi study’s first round of item ranking reduced this pool to 28 items for consideration. This pool was further reduced by the experts to 15 items for consideration in the second round. Experts also suggested that items be merged due to their similar nature or construction. This process allowed for further item reduction to 11 items with content validity and no redundancy.
The need for a tool to assess appropriate aspects of HRQoL in infants and young children became apparent as items included in existing measures did not cover the required spectrum. The final items were chosen based on a solid conceptual model, acceptability to stakeholders, and consideration of the item’s observability. Before developing a new measure, the pruned item bank of 11 items must be tested further with the target population to ensure validity and reliability.
Child, Infant, Toddler, Preschooler, Health, Health-related Quality of Life (HRQoL), Proxy
Go to: History
Young children are more vulnerable to illness, with mortality in children under the age of five accounting for nearly 20% of global mortality [1, 2]. Technologies that reduce mortality and morbidity are becoming more widely available, albeit at a high cost (e.g. neonatal intensive care support, management of terminal diseases). Difficult decisions about resource allocation in care must thus frequently be made at both the health authority and individual patient levels, and cost-effectiveness analysis (CEA) can help guide these decisions . To help decision makers, the Quality Adjusted Life Year (QALY) has been developed, which incorporates time spent in a health condition and Health-Related Quality of Life (HRQoL) . There are numerous HRQoL measures in use, but the majority are aimed at adults and older children, and it is unclear how applicable the included dimensions and items are to younger children.
HRQoL is measured on a multidimensional scale . This multidimensionality follows the World Health Organization’s (WHO) definition of health, which includes three dimensions: physical, mental, and social . The four generally accepted dimensions of HRQoL are disease and symptoms, health status, psychological and social functioning, and an additional dimension of functional status . These dimensions are consistent throughout the lifespan. The majority of HRQoL definitions emphasize the perceived effects of health on physical, social/role, psychological/emotional, and cognitive functioning. Disease symptoms, health perceptions, and overall Quality of Life are frequently included as dimensions of an HRQoL measure . HRQoL is defined as the perceived effect of a medical condition or its management on a person, which can be general or specific to the health condition.
HRQoL measures are classified into two types: disease-specific and generic measures. Typically, disease-specific measures are developed to assess the effects of a specific disease or condition on HRQoL . Disease-specific measures, according to the argument, are more responsive because they detect disease-specific clinical changes . Disease-specific measures, on the other hand, are limited to assessing HRQoL in the disease for which they were developed, and thus cannot provide comparative data across disease groups or between disease groups and the general population . Generic health measures can be used to collect data from both healthy and ill individuals. Generic measures thus have a wider application and can be used in population health surveys, burden of disease studies, epidemiological studies, screening, describing health status, developing management plans for individual patients, informing clinical policy and resource allocation decisions [8–14].
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Measurement of HRQoL in very young children (defined here as under five years of age) is challenging as motor and cognitive development is rapid and measurement of HRQoL needs to take into account the changes which emerge with this development . A further constraint is that young children are unlikely to self-report reliably and measures for very young children need to rely on proxy-report . This has the disadvantage that several items in existing HRQoL measures require the proxy to report on the subjective experience, of the child which may reduce the reliability of the measure . Thus the Food and Drug Administration (FDA) and International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines suggest that proxy-measures for HRQoL be based on observable measures to minimise bias [16, 17]. A measure based on observable behaviour requires that each item is assessed according to observable behaviour of the child without the respondent having to draw conclusions regarding the child’s experienced HRQoL based on their own subjective assessment .
Systematic literature review of generic HRQoL measures for children had concluded that no existing measures were based solely on observable behaviour and most of the measures had not been developed based on a conceptual model [6, 18, 19]. There was thus a need to develop a new HRQoL measure, for young children, to be completed by proxy. To ensure that a new measure would add value to the existing measures, it was necessary to identify which items were of importance in this rapidly developing age group and how to ensure that reporting on items would be based on observable behaviour.
We reviewed a wide range of theories and models to identify the most appropriate guiding framework for the development of the new measure. The Wilson and Cleary Model is the oldest and most cited model of generic HRQoL  and suggests that the values and preferences of an individual will affect their overall HRQoL . The Wilson and Cleary Model , the disease specific Taylor Model , and the International Classification of Functioning, Disability and Health (ICF) which includes a model of functioning [24, 25] all recognise the impact of personal factors and the environment in an individual’s perception of their HRQoL [20, 21, 23, 25, 26]. These models are similar in that they take into account the importance that personal factors and the environment make in the relationship between these key areas [20, 21, 23, 25, 26], they all take into account the presence or absence of disease or a health condition [21, 23, 25, 26] and they all include aspects of physical functioning [21, 23, 25, 26]. However, none of them account for the unique aspect of development which is a key aspect in the very young child.
The rapid development and acquisition of skills during the first years [27–29] of life also needs to be considered when developing a new measure. The theories of child development foreground the importance of the first years of life in shaping future adults and these early stages are commonly disrupted by negative experiences related to poor health [30–36]. Both the Taylor and ICF models take development and change in functioning over time into account, an element that is clearly essential when dealing with infants that are rapidly developing social, motor and other skills. Bakas et al. , however, suggest that the ICF may be more applicable across age and cultural groups as it was designed to describe the health of individuals, families, communities and populations across cultures. The ICF model with consideration of child development across the age range was thus used to inform the choice of items in this study.
The aim of this study was to establish a bank of items which would cover all the components of HRQoL relevant to the age group. This was to be done by interrogating items in existing HRQoL measures for young children and by generating further items through engagement with stakeholders. The selection of items would take into account the ISPOR  and the FDA  guidelines for HRQoL instrument development for very young children. The process of generation of the item bank and descriptors included a systematic review of the literature of existing HRQoL for young children; cognitive interviews with stakeholders including the target group (caregivers of young children) and a Delphi study [37, 38] with experts in the field of child health and HRQoL to prune and finalise the item bank for further psychometric testing. The process and results of the literature review and cognitive interviews with carers are summarised below. This paper describes the Delphi study component in detail.
Go to: \sGeneration of comprehensive item bank
A systematic review of HRQoL measures for children under seven years of age was undertaken both to identify suitable items and to identify an instrument which could be used as a departure point of discussion on HRQoL with caregivers.
A search strategy for use on electronic databases was developed based on previously published literature as well as expert knowledge from the task group. The only limit to the searches was the exclusion of non-English articles or abstracts. Articles were searched in each database from the beginning of each database until April 2017. Pearling, which entails using the literature at hand to identify additional relevant studies, was done by hand searching the references of sourced papers. The websites of identified measures were also consulted for additional manuals or reference papers. The following electronic databases were searched: PubMed, EMBASE, Web of Science, PEDro, EBSCOHost, Africa-wide, NiPAD, CINAHL, ERIC, Health Source- Nursing/academic edition, MEDLINE, PsycARTICLES and PsycINFO, Scopus, Academic Search Premier. Conference proceedings from ISPOR and ISOQoL for the years 2012, 2013 and 2014 were searched for relevant literature. The terms in the title (“Health-Related Quality of Life”, OR “Quality of Life” OR “well-being” OR “health status”) AND (“children” OR “paediatric” OR “pediatric” OR “infant*” OR “child*”) AND (“questionnaire” OR “instrument” OR “measur*”) AND “generic” AND (“validation” OR “develop*”) were used to identify articles. Self-report and proxy report generic measures of HRQoL, health status and wellbeing were included. Measures were excluded if: they were disease specific, their dimensions were restricted to demographic or environmental indicators, and they only measured a single dimension or were used exclusively in children over the age of seven years.
A data abstraction form was used to record the literature reviewed. The researchers referred to the COSMIN checklist and all the criteria were recorded as well as information pertaining to bibliographic details, description of instrument development, completion by self/proxy, descriptive dimensions, number of items, response options, reference of the question to the child’s normal behaviour or the behaviour of others, recall period and scoring of the instrument. Attention was paid as to whether the items related to observable behaviour, if this was defined and whether developmental changes were factored into the measures. A second reviewer corroborated on the analysis and conclusions.
Discussion Topic: Discuss the underlying assumptions and potential ramifications of having proxy subjective health status or evaluation measures for children or those unable to speak for themselves.
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