Towards a decision aid for self‐tests: Users’ experiences in The Netherlands

Abstract Background Self‐tests enable the identification of (risk factors for) diseases and are carried out on the user's initiative without medical indication or advice and often unaided by a health professional. They are frequently used, and their availability and usage are expected to grow. Self‐testing has both advantages and disadvantages. Making a well‐informed decision about whether to self‐test and which self‐test to use is of major importance. Objective To provide insights into the experiences of self‐test users, identifying reasons to self‐test and perceived (dis)advantages of using self‐tests and the information highlighted as relevant by self‐test users to make well‐informed decisions. Methods In a qualitative study, 28 users of a wide variety of self‐tests shared their experiences in focus groups and interviews. Results Perceived disadvantages of self‐testing included the following: a wide range of available self‐tests, lack of insights into their reliability and content, possibility of mistakes in administering them, possibility of false‐positive and false‐negative results, lack of clarity about how to interpret results and consequently what action to take and fear of not being taken seriously by a general practitioner. Self‐test aspects that were viewed as most important include informed decision making, user‐friendliness, usefulness and reliability of results. Conclusion A decision aid for future self‐test users can help people make a deliberate decision on whether to use a self‐test and which particular self‐test to use from the wide range available. The government, health professionals, patient organizations, consumer organizations and citizens all have a role to play in the development and implementation of a decision aid.


| INTRODUC TI ON
Self-tests enable the identification of risk factors or early stages of diseases and are carried out on the user's initiative, without a medical indication or advice and often unaided by a health professional. There are many different types of self-tests (see Table 1).
Four types of self-test on bodily material (eg blood, urine and saliva) can be distinguished: (a) over-the-counter tests, in which consumers are alone responsible for the execution and interpretation; (b) home-collect tests, which require consumers to ship a sample of bodily material to a laboratory for analysis, after which they receive the results of the test by post or Internet; (c) direct-access tests, which require consumers to provide a sample while physically in a laboratory setting for analysis, after which they receive test results (eg by post or Internet); and (d) street-corner tests in which consumers may opt (without a doctor's recommendation) to have their sample taken in a public place (eg supermarket or drug store) by trained personnel, after which they immediately receive the results. 1 In addition, there are various types of self-tests that do not involve bodily material. These include health-related questionnaires which assess risk factors for certain conditions (eg cardiovascular disease), give insight into the overall health status of a person or assist in the diagnosis of conditions (eg mental health conditions), as well as various health checks offered by employers, gyms and private clinics (eg total body scans, measurement of body mass index and blood pressure). If costs are involved, self-tests usually need to be paid out of pocket (not reimbursed by health insurance). 2,3 Over the past decade, self-tests have become more readily available. First, there is an increase in both the number of conditions one can diagnose through self-tests and the number of self-tests on the market for each condition. In the UK, 104 self-tests were identified in an Internet survey, which is related to 24 conditions. 4 Second, locations that provide self-tests are becoming more abundant: pharmacies and online stores increasingly sell self-tests; street-corner tests are increasingly offered; private clinics regularly advertise for total body scans; and the Internet is now full of websites which offer diagnostic/risk factor questionnaires. Moreover, the availability of self-tests is expected to continue to grow. 5,6 In line with the growing availability of self-tests is their frequent use. In a cross-sectional survey in the Netherlands, 16% of the 7919 participants indicated having at some time used a self-test on bodily material. 1 The same study showed that 17% of those who had never used a self-test expected to do so in the future, and 54% even stated a preference for self-tests over other forms of testing. A questionnaire survey in the UK showed that 47 per 1000 women and 22 per 1000 men have at some point used a self-test on bodily material (other than a pregnancy or high blood pressure test). 7 The most frequently used self-tests in Germany, the UK and the Netherlands include those for cholesterol, glucose, diabetes, kidney disease, HIV, chlamydia, lactose intolerance, allergies, vaginal infection and urinary infection. 1,[7][8][9] The frequent use of self-testing might be connected to an advantage that is often mentioned: convenient alternative for visiting a GP and taking responsibility for one's own health. 2 For example, after testing positive for risk factors, one might take responsibility and change one's health behaviour in order to avoid disease. The idea of taking responsibility for one's own health, often connected to the concepts of self-management and autonomy in health, is in line with the position increasingly taken by governments in most welfare states (including the Netherlands), which encourage citizens to take responsibility for their own health and their health behaviour. 12 There are, however, also a number of potential disadvantages to self-testing. False-positive results may cause distress in the self-tester and lead to higher costs in the health system for unnecessary follow-up tests. 8 Delay in treatment may be caused by false-negative results, either when the self-test user is wrongly reassured, either because the test is inaccurately applied, or because the test results are incorrectly interpreted. A true-negative result may also lead to delay in treatment when a self-test is carried out for the wrong condition or if the results are misinterpreted. 6,13 Due to the increasing use of self-tests and their rapidly growing availability, it is crucial to counteract the disadvantages of TA B L E 1 Inclusion of self-tests per category

| M E TH O D S
Using a qualitative research design, semi-structured interviews (SSIs) and focus groups (FGs) were conducted.

| Inclusion
To gain a broader insight into experiences of a diverse group of selftest users, maximum variation sampling was applied. Participants were invited if they met the following inclusion criteria: • The self-test belonged to one of the following categories: (a) selftest on bodily material, (b) health-related questionnaires and (c) health check outside routine health care (see Table 1).
• The self-tests had been carried out in the last four years, except for the health-related questionnaires, which should have been carried out within the last two years, since this type of self-testing is more frequently used.

| Recruitment
Participants were recruited through calls on the websites of two major Dutch patient organizations and one Dutch consumer association. Most of the participants had read the announcement on one of these websites and applied to be a study participant. Several participants were made aware of this study by acquaintances. Researchers checked each applicant on the inclusion criteria before including them as a study participant.

| Data collection
FGs are an appropriate method for in-depth exploration of perspec- aspects of self-tests that arose. These were noted by the interviewer/facilitator to be added in the analysis when deemed appropriate. In total, 28 test-users participated in this study in two FGs (n=13) and three SSIs in the category of self-test on bodily material, two FGs (n=9) in the category of health-related questionnaires, and three SSIs in the category of health checks outside routine healthcare (see Table 2).
As this study was deemed "non-invasive" by Dutch law, and all participants were above 18 years of age, we did not require approval from a formal medical ethical committee. 14

| Analysis
All FGs and SSIs were audiotaped and transcribed. Content analysis using thematic and open coding was used to analyse the transcripts with qualitative software MAXQDA. Two researchers read and reread all transcripts. A coding scheme was made by each researcher individually based on the first two transcripts, and after comparison and discussion, a unified coding scheme was developed. While coding the other transcripts, the coding scheme was regularly discussed and adjusted based on new findings.

| Reasons to self-test
The participants voiced various reasons for choosing a self-test and revealed several advantages of self-testing (see Table 3). The most frequently mentioned reasons were to diagnose or obtain reassurance of (not) having a health condition (ie disease or risk factor); the ability to gain insight into and knowledge of one's health status; TA B L E 3 Reasons to self-test and perceived advantages of self-testing per type of self-test

Self-test on bodily material
Health-related questionnaire

Health check outside routine health care
Diagnosis/reassurance Linking experienced symptoms to a health condition and using a self-test to diagnose or reassure themselves and thus providing a sense of relief X X X

Gain insight
Even though no complaints are experienced, it is good to have insight into one's own health status X X X

Curiosity
Even though not actively looking for a self-test and no complaints are experienced, curiosity may be triggered when self-tests or offered X X

Prevention/action
Being able to take action and possibly prevent health conditions (eg by lifestyle changes) based on self-test results gives a strong positive feeling (doing something right). Motivation to take action is higher after self-testing than after testing in regular health care X X X

Autonomy and independence
Taking responsibility for one's own health and a feeling of independence and freedom (eg to choose whether or not to test and which test). Autonomy over one's own body and being the professional over on one's body. Important reason to not chose for testing in regular health care X X

Convenience
Shorter timeline from deciding to want to test until obtaining results. Being able to test where and when it is convenient (eg in the comfort and privacy of one's own home) X X X

No GP
Having an uneasy feeling or being scared to visit a GP. Not wanting to bother a GP. GPs do not offer many preventive tests, especially not without specific symptoms X X

Costs
Costs of self-testing might be lower than when testing in regular health care due to a doctor's consult and laboratory analysis. At the same time, out-ofpocket payment for self-testing is not considered as negative X possible prevention of a health condition and the ability to take action; and the convenience of self-testing.

| Perceived disadvantages
The disadvantages experienced by the participants are divided into four stages of self-testing: (a) deciding to self-test; (b) conducting the self-test; (c) obtaining the self-test results; and (d) after the selftest. Aspects that did not fit into these four stages are mentioned separately.

| Deciding to self-test
At this stage, people are deciding whether or not to use a self-test and which one would be appropriate. In the categories of self-tests on bodily material and health-related questionnaires, the wide range of self-tests on the market was often experienced as a disadvantage.
For the first category, it was stated that many manufacturers produce self-tests resulting in differences in costs as well as in the quality and reliability of the tests, into which the potential users had no insight. What

| Obtaining self-test results
This stage focuses on how results are obtained or presented, the information they provide and how the results are interpreted by users.

| After the self-test
This stage entails all aspects of self-testing that play a role after the results are obtained. First, users of self-tests on bodily material often mentioned the experience of stress without the support of a health professional as a disadvantage. Several participants explained that when the results are false-positive, people will look up information about the condition which will lead to unnecessary worries. More importantly, they stated that whether or not results are false-or true-positive, they would have to "carry" this knowledge "alone":

| Additional disadvantages
Many users of health checks outside the formal health system experienced the feeling of shame as a disadvantage of self-testing throughout the whole process. This feeling was experienced towards their social surroundings, because self-testing outside the formal health system is seen as out of the ordinary. For example, people addressed the personal costs involved and the commercialization of the tests. One participant experienced this especially when no condition was found in self-testing, but later on was diagnosed within the formal health service.

| Important aspects of self-tests
Aspects of self-testing experienced as most important are divided into three main categories: informed decision making, user-friendliness and reliability of results (see Table 4).

| Informed decision making
Informed decision making was mentioned as an important aspect for all categories of self-tests. Participants reflected on what information was needed in order to enable future self-test users to make a better-informed decision, and mentioned their ideas for how to improve self-tests.
One of the aspects most often mentioned was the clarity of in- underlined. In this way, the chosen self-test will better fit the needs of the future user and it will be less likely that the results will give a false sense of security or lead to unnecessary worries. For the health-related questionnaires, it was also mentioned that the source of the questionnaire should be clearly stated and users should be informed about how much time it will consume.
Second, it was perceived important to be able to compare the wide range of options. Quality assurance in the form of a certification mark by an independent institute was broadly considered desirable for self-tests. Users of health checks outside the formal health system specifically stated that it is important for future users to be aware of the competition between clinics and the information on clinics' websites should not be the main source of information.
Rather, there should be a way to compare clinics, for example a comparison between the type of tests offered and possible health conditions to test for. Another comparison that participants recommended was between using a self-test on bodily material versus being tested within the health system. In addition, for self-tests on bodily material it should be clearly stated, especially when bought on the Internet, if the test is suitable for self-use or is for professional use only.
The (possible) use of results is a third important aspect that needs to be clear in advance in order to make an informed decision. Users of self-tests on bodily material as well as users of health checks outside the formal health system often mentioned the importance of being able to use their self-test results in the formal health system and being taken seriously by health professionals.
Call the GP's office to say: 'I have done this or that self-test, I expected these results, and these were the actual results. Do you feel that I should come by for an appointment or not?' (P6, FG1/2) For the health checks outside the formal system, it was specifically mentioned that it would be beneficial for the private clinic to provide information on the tests conducted and results to the user's GP when this is desirable.
With respect to health-related questionnaires, users emphasized that it is important to make clear in advance if and how the results will be used by the provider of the questionnaire: specifically, whether the results be used for scientific purposes and (how) anonymity will be safeguarded. This was mentioned especially for online questionnaires, since it often is unclear what happens with information provided online.

| User-friendliness
User-friendliness was seen as an important aspect for self-tests on and easy-to-read font. Second, administering self-tests should be easy and user-friendly. The steps of carrying out the self-test on bodily material should be simple and give as little discomfort as possible.
The questions and answer options in the health-related questionnaires should be understandable and unambiguous.

| Usefulness and reliability of results
The usefulness and reliability of the results were specifically mentioned as an important aspect by users of self-tests on bodily ma-

| D I S C U S S I O N
Participants were clearly aware of their own health, and they took responsibility for it and saw self-management of their health as being important. This is in line with the literature, which shows a trend of people taking responsibility for and managing their own health. 2 Many reasons to self-test identified in this study are also found in other studies, 9 for example being uncertain about one's health and looking for reassurance or confirmation, not wanting to visit a GP, convenience and costs of self-testing. Noteworthy is that in our study prevention and the ability to take action were of major importance, while in a German study 16 these were less frequently mentioned reasons.
The participants in our study indicated several problematic issues during the four stages of self-testing. These were experienced not only as obstacles for a good experience with self-testing for themselves, but also as on-going problems that future self-test users would face when deciding whether to self-test. Two issues that were raised when discussing disadvantages of self-testing were not translated into important aspects of self-tests that possible future self-test users should bear in mind.

| Well-informed decision making
Although taking responsibility for one's own health is a trend which addresses the needs of the public and is encouraged by both health professionals and the Dutch government, support for citizens in well-informed decision making concerning self-testing seems to leave much to be desired. The Dutch health system responds rather ambivalently to self-testing. Policymakers and health professionals are generally positive about people taking responsibility for their own health and GP consultation for preventive purposes is becoming more common, but in practice, the Dutch health system does little to facilitate and support the use of self-tests. There are limited options for citizens to take a preventive test in the formal health system especially without an indication, and the Dutch government has not actively facilitated informed decision with regard to self-testing.
Self-testing is one of the ways for people to manage their own health. To achieve this, self-testing should be more integrated in society and the health system, meaning that help and support are offered to (future) self-testers to make a well-informed decision on whether or not to self-test and subsequently which self-test to use. Governments and health care organizations also need to take responsibility in facilitating people's wish to manage their own health. An important role for the government is to set legal boundaries. First, awarding an independent quality or certification mark to self-tests is something the government could do. This should be based on, among others, criteria provided by self-test users, such as the important aspects of self-tests shown in Table 4. In this way, comparisons between the broad range of self-tests on bodily material, private clinics providing checks and different health-related questionnaires do not have to be made by the future users themselves, but would be supported by government policy. Second, the government should ensure that certain information about self-tests is made available (see Appendix S1). It is also important that in formal health settings, such as at the GP's surgery, the decision aid should be brought to the attention of possible future self-test users.

| Methodological considerations
In this study, triangulation of sources was achieved by including a wide diversity of test users (different backgrounds and different self-tests) providing insights from various perspectives. For the category of self-tests on bodily material and health-related questionnaires, FGs were complemented with interviews for self-tests on bodily material, providing triangulation of methods. Data saturation was achieved since no new aspects were brought up during SSIs and FGs. However, regarding the health checks outside formal care three interviews were carried out and it is unclear whether saturation was achieved. This relatively low number of participants was due to the limited response to the (repeated) calls for participants. This could be due to the low number of people in The Netherlands carrying out health checks outside the formal health system, but may also be linked to the stigma surrounding this category of self-testing and the feelings of shame experienced by self-test users in this category, as explained in the results under "additional disadvantages".

| CO N C LU S I O N
Self-test use is frequently practised and is likely to increase in the coming years. Self-testing is a way for people to take responsibility for their own health. Self-testing is not in itself a positive or negative phenomenon and may have different implications in each individual case. In order for future self-test users to make well-informed decisions, the availability of a practical tool is highly relevant. Such a tool should include an overview of information on self-tests and quality criteria, and also integrate the experiences of self-test users. A decision aid may help to make a deliberate decision on whether to use a self-test and which particular selftest to use. The government, health professionals, patient organizations, consumer organizations and the general public all have a role to play in supporting informed decision making on self-test.
We believe that this study provides important first insights into the content of a decision aid, based on the experiences and needs of self-test users. We encourage more in-depth research into the impact of the use of such a decision aid.

ACK N OWLED G EM ENT
We would like to thank the VSOP for commissioning this research and their input in the research design and execution. Furthermore, we extend our gratitude to the Netherlands Patient Federation and the Consumers Association for their efforts in recruiting participants. We would also like to thank L. Verkerk for her assistance in organizing the research, facilitating focus groups and carrying out interviews. Most of all we would extend our gratitude to the selftest users who shared their experiences during the focus groups and interviews.

CO N FLI C T O F I NTE R E S T
The authors declare that there is no conflict of interest.