Health care systems in many countries have become more and more complex and confusing as a result of increasing expansion and specialization over the past decades [1
]. Thus, the demands on patients and users to orient within and navigate health care systems are increasing as well [6
]. Patients are required to identify an adequate entry point to the health care system, to orientate themselves within a multitude of organizations, to maneuver through the system, and to find the right place for their own problems [7
]. Similarly, it is important to find one’s way around the organization and to interact and communicate in such a way that the questions and problems encountered are adequately answered and informed decision making for health care is possible [11
]. Not all patients and users are able to meet such navigation requirements, leading to disorientation, futile and stressful searches, uncertainty, and discontinuities in health care [12
]. Studies indicate that this particularly affects people with low health literacy [14
]. They have more problems in finding their way within the health care system and in dealing with the often-complicated information.
Following the definition of the HLS-EU Consortium [18
] (p. 3) comprehensive health literacy can be understood as the “knowledge, motivation and competences, to access, understand, appraise, and apply health information in order to make judgments and take decisions in everyday life concerning health care, disease prevention and health promotion to maintain or improve quality of life during the life course”. When it comes to using and navigating the health care system, a specific form of comprehensive health literacy is required, i.e., navigation health literacy (HL-NAV). HL-NAV includes being able to handle information in such a way that it is possible to navigate the health care system without any difficulty and to “find the right care at the right time in the right place” [19
] (p. 14). Whether this is successful depends on the one hand on the abilities of the individual, as described by Sørensen et al. [18
], and on the other hand on the demands and complexity of the system that must be navigated [20
While the empirical knowledge about health literacy in populations is increasing, the topic of navigation in health care has received relatively little specific attention. When navigation problems are addressed, this is mostly done with regard to barriers or coordination deficits in health care, the management of (chronic) illness [21
], as well as in terms of the objectives of compensatory intervention concepts, such as case or care management and patient navigation [25
]. The ability to handle information in order to find one’s way around the health care system, is still rarely studied. Although the work by Rima Rudd and colleagues [28
] took the topic quite early on the agenda, comprehensive analyses of HL-NAV are still missing until today. This is why the issue was integrated as an optional package into the International Health Literacy Population Survey 2019 (HLS19
). The HLS19
project is part of the M-POHL Network, which was established under the umbrella of WHO Europe’s Health Information Initiative (EHII) with the adoption of the Vienna Statement on the Measurement of Health Literacy in Europe [29
]. The survey aims at measuring health literacy in different countries based on the concept and the instruments of HLS-EU [30
also includes newly developed supplementary packages. HL-NAV is one of them. For this purpose, a new instrument for measuring HL-NAV was developed for cross-country comparisons and monitoring, as well as for intervention development. The steps taken to achieve this are described in this article.
2. Materials and Methods
The procedure followed standards for the development of measurement instruments in social science survey research [31
]. The entire process is outlined in Figure 1
. The steps undertaken were part of the preparation for the HLS19
and were carried out within the M-POHL Network. A working group on measuring HL-NAV was established, consisting of seven international experts from countries participating in the HLS19
(Germany, Austria, Switzerland, Norway, Portugal, and Czech Republic) and led by the first and last authors. Representatives from HLS19
countries interested in developing the package HL-NAV were able to join the working group at the early stage of HLS19
The project was conducted in accordance with the Declaration of Helsinki; focus group discussions were approved by the Ethics Committee of Bielefeld University (application number EUB 2019-247).
2.1. Scoping Literature Review
At first, a scoping literature review using Arksey and O’Malley’s [32
] approach was performed to obtain an overview of existing definitions, concepts, and instruments in the field of navigation with a special focus on health literacy. The underlying research question was: Which approaches exist to conceptualize and measure navigation in the health care system and what role does health literacy play? The search was carried out in PubMed and CINAHL from November 2018 to January 2019. It was extended by a hand search. A combination of the keywords (health services, health services accessibility, health organization, health care system, health care, health care literacy, navigation, orientation, patient experience, patient preference, patient perception, patients’ view, family perspective, consumer, user, caregiver, patients) was used. The detailed procedure, inclusion and exclusion criteria are listed in the Table A1
and Figure A1
2.2. Conceptual Framework for HL-NAV
In a second step, a working definition of HL-NAV was developed that addressed the underlying understanding and principles of health literacy [18
] as well as the findings from the reviewed literature. Afterwards, concept mapping of the main HL-NAV tasks was carried out. Concrete information tasks, which patients and users must perform while navigating health care systems were derived from literature, discussed, supplemented by the research team, embedded in the context of information processing, and revised throughout the development process.
2.3. Item Development and Evaluation
Finally, items matching these tasks have been developed. The wording and response scale of the European Health Literacy Survey Questionnaire (HLS-EU-Q) was applied for item development. The HLS-EU-Q captures the subjective difficulties in accessing, understanding, appraising, and applying health information in three domains: health care, disease prevention, and health promotion and therefore assesses “comprehensive” health literacy [30
] (p. 19). Existing items from instruments identified by the literature review (step 1) and from instruments referring to single HL-NAV tasks [34
] were adjusted and reformulated to fit into this format of operationalization. In addition, new items were formulated for tasks where no items could be retrieved from the existing literature.
The initial item pool was evaluated with regard to its importance by six German speaking experts from health literacy research (n = 2), and health services research (n = 1), also by stakeholders in health care (n = 3). The Content Validity Index for Items (I-CVI) and Scales (S-CVI) was applied to quantify content validity—a method widely used to establish and quantify content validity in diverse fields [37
]. Experts were requested to give written feedback on the proposed items by rating how well each item reflected the working definition of HL-NAV on a 4-point-Lickert scale from “1 = not relevant” to “4 = highly relevant” as requested by Davis [38
]. The I-CVI was computed as the proportion of experts giving a rating of either 3 or 4 [37
]. The S-CVI was calculated by the averaging calculation approach (S-CVI/Ave) using the average of the I-CVIs for all items on the scale. Furthermore, experts were asked whether each item is comprehensible and clearly formulated and whether they have any recommendations and subjects which had thus far not been considered.
In a next step, items were discussed in four different focus groups—a procedure which is frequently used in initial item development [39
]. The aim was to gain feedback on the clarity and interpreted content of each item. Furthermore, additional recommendations provided by the participants were noted. The focus groups were organized by a professional institute. Two focus group discussions with eight participants each took place in an urban region, and two were carried out in a more rural region. The participants had different socio-demographic backgrounds. In concrete, for 3/4 focus groups a different selection criterion was used (chronic illness, low level of education, unspecified migration background). In addition, one group was conducted without any predefined criteria. Further overarching criteria were a balanced gender ratio and a balanced age distribution as possible. Participants had to be over 18 years. Each focus group was moderated by two researchers.
The final instrument to be used for Germany was pre-tested in thirty-three personal face-to-face interviews. These interviews were conducted by interviewers from a professional research institute. The interviewees were recruited from the general population aged 18 and over. A balanced distribution of gender, age, and education was sought here. In parallel, a pre-test under field-conditions was performed by twelve staff members of the institute, half of them as interviews and the other half as expert reports. The results of the two pre-test modules were collected and evaluated together with the research team.
During the entire development process, the current item status was constantly translated back and forth between German and English in order to obtain feedback from the working group members. The methodological approach and the status of the instrument were also presented and discussed at two M-POHL meetings in Dublin and Berlin within the whole HLS19 Consortium. To ensure that the English translation meets the initial intention, the final English version was also translated back by an external survey agency into German. A final language check for the German version was conducted with two researchers from Austria and Switzerland with regard to translation and country/system-specific wording.
The fragmentation, complexity, and non-transparency of health care systems and the resulting problems have long been discussed and criticized [2
]. However, the consequences for patients are far less often taken into account. However, patients are the ones to suffer the most from complicated und fragmented health care systems because such systems cause supply deficits and impede easy navigation and use of health services. The same applies to information required for navigation: it is also not easy to find, often difficult to understand, and can only be used to a limited extent for orientation and health services use. Therefore, it is all the more important to analyze the difficulties in navigation, and even more so the HL-NAV, necessary to better deal with it, in more detail. So far—as the literature analysis and comparable reviews on health literacy have shown [57
]—this has been done only very cautiously.
The development of the instrument described here is an attempt to contribute to this aim. With the use of the instrument in the HLS19
, data on HL-NAV in several countries will be collected for the first time. This will provide important comparative insights for intervention development and further research. In terms of content, the instrument focusses on the use of health services by patients and the role of health literacy in this context. Conceptually, it is based on a multidimensional understanding of health literacy that includes functional skills but goes beyond these and includes interactive and critical skills that are relevant for the context of navigation. It therefore gives equal weight to the information dimensions (accessing, understanding, appraising, and applying) regarded as central to health literacy and anchored in the underlying framework [18
]. Furthermore, health literacy is understood as a relational construct [20
]. By measuring the subjective difficulties in dealing with health information, a relational understanding of health literacy is taken into account—as has been the case in the comprehensive instrument of the HLS-EU. At the same time, the developed instrument goes beyond a clinical perspective and allows an assessment of HL-NAV in different populations. Therefore, it meets the demand for an increased operationalization of health literacy from a public health perspective [33
]. A further strength of the tool is that its underlying concept maps HL-NAV at the system, organization, and interaction levels. Previous instruments mostly lack these detailed perspectives.
For the validation of items by focus groups or cognitive interviews, the literature discusses the possibility of involving either laypersons or people with background knowledge [58
]. The focus groups in this study primarily involved people with no proven knowledge of the health care system, even though there was a high proportion of the chronically ill, who probably had greater system experience and probably also knowledge.
The validity of the content, as assessed by the CVI, allowed a relatively easy estimation of the relevance of the single items and the suitability of the entire instrument. The number of 6 experts/stakeholder in this study can be considered as appropriate for ensuring content validity [37
]. If there are six or more judges, the I-CVI should not be lower than 0.78. For the S-CVI, it is indicated that a value of 80 or higher is acceptable [38
]. The CVI for the entire item pool (S-CVI) fulfils the requirements highlighted in the relevant literature. The CVI for individual items (I-CVI) allowed a targeted revision of the instrument. However, at this point, a quantifiable assessment of the content validity could only be made for the initial item pool, since the results of the validation and additional feedback in the development process led to further adjustments and additions to the instrument. Nevertheless, the substantive focus has been maintained, so that it is assumed that the instrument complies with the criteria of content validity applied here.
It is also emphasized that the instrument was developed involving international experts, important stakeholders, and also patients and users of the health care system. During the development process feedback from members of the HLS19 Consortium was continuously collected. These included proven public health and/or health literacy experts in their respective countries with extensive research and/or policy experience. In addition, the views and perspectives of the relevant patient and user groups proved to be valuable. However, patient and user views could only be included from Germany, as the focus groups and pre-test were performed only in this country. A more extensive validation of the instrument in other countries is needed and will be possible in HLS19, since six more countries than Germany are planning to include this specific instrument also in their surveys (Austria, Belgium, Switzerland, France, Portugal, Slovenia). Furthermore, psychometric properties of the instrument need to be evaluated when population data are available.
In general, the broad approach taken in the item evaluation and finalization phase of the instrument allowed a variety of different perspectives to be incorporated. This proved to be fruitful in terms of patient and user participation, as well as for the applicability of the items to different country and system contexts. The instrument can thus be used not only in the context of HLS19, but also in other national and international population surveys.
Nevertheless, some limitations of the procedure also have to be mentioned. With the help of the scoping review, an overview of the existing definitions, concepts, and instruments could be obtained. However, since the object of the search encompassed a wide range of dimensions, levels, and labels it was difficult to find appropriate search terms. However, to minimize the risk of overlooking important publications, broad and general search terms were defined. This resulted in a high number of hits, of which most articles did not meet the inclusion criteria, after closer inspection. In addition, the concept mapping was mainly based on the identified literature, but the concept was further elaborated taking the developed definition of HL-NAV into account. Concept mapping workshops could not be carried out. However, the concept was intensively discussed and commented upon by experts of the HLS19 Consortium. A further restriction should be mentioned in terms of content. HL-NAV is primarily conceptualized with regard to the health care system and its socio-spatial environments because the demands on navigation are particularly high in this respect. However, there are also navigation requirements and difficulties in the area of disease prevention and health promotion. The same may apply to virtual and digital environments as well as in terms of communication and interaction: Certain expectations and rules are tied to the patient role, which is quite different from the role as client or consumer in the health care system. To find one’s way around these rules and norms, which have also changed considerably in recent years, navigation skills are also required. Thus, the transferability and further development of the concept to these and other relevant areas need further examination in the future.
The article describes the development of a new instrument to assess self-reported difficulties in processing information for navigating the health care system—the HL-NAV-HLS19. Thus, a topic is put on the agenda that—as this study demonstrates—has previously received little attention in health literacy research and instrument development.
Overall, the multi-step approach involving experts, stakeholders, and health care users enables a systematic and participatory development of the instrument in general populations in different countries. The integration of a professional perspective gives the opportunity to sharpen the contextual focus of the instrument. Key adjustments regarding comprehensibility and practicability were enabled by those who interact directly with the health care system as patients or users. The participation of international experts was considered mandatory, as the instrument is to be applied in an international context. These steps proved to be elaborate and time-consuming, and thus should be taken into consideration when planning new population surveys.
It can be assumed that a viable and feasible instrument has been developed that will generate comparable data on HL-NAV in different countries, for the first time, in the near future. Nevertheless, some caution should be made in terms of transferability because the validation steps to this point were only performed in Germany. Further research on the topic and the instrument is necessary and will be done with help of HLS19 data in seven countries.