Advertisement by medical facilities as an opportunity of APOE genetic testing in Japan: a website analysis

doi:10.21203/rs.3.rs-2232245/v1

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Advertisement by medical facilities as an opportunity of APOE genetic testing in Japan: a website analysis

https://doi.org/10.21203/rs.3.rs-2232245/v1

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Background: The APOE-ε4 allele[s] is a strong risk factor for Alzheimer’s disease (AD). Its significant opportunity route includes out-of-insurance APOE testing services provided in medical facilities in Japan via their website advertisements. Therefore, there is a concern that adequate self-determination of whether to undergo APOE testing may be spared depending on the content of website advertisement descriptions.

Methods: In this study, we searched medical facility websites in Japan advertising APOEgenetic testing as one of their services. The defining features of the advertisements were manually assessed based on deemed-preferable features that we prespecified in the aspects of legal regulations or other applicable guidelines published by related societies.

Results: We identified 220 medical facilities that had created advertisements for the provision of APOE genetic testing on their websites. Of these, 85% were small clinics, and the remaining 15% were outpatient departments of large hospitals. The median cost of APOE testing (when clarified) was US$ 123.1 (in 143 JP¥/US$). Contact information, details, and costs of testing were described on most of the websites. Meanwhile, features’ explaining APOE as a risk gene,’ ‘notes on interpreting APOEresults,’ or ‘explaining examination methods (e.g., blood sampling) were described to a variable degree depending on individual facilities. ‘Notes on genetic testing’ or ‘genetic counseling’ were hardly referred to, and ‘specialists with appropriate expertise’ were considered to participate in clinical practice in approximately one-third of these facilities providing APOEtesting services.

Conclusions: These results suggest that self-determination on taking out-of-insurance APOE testing at some medical facilities in Japan may possibly be influenced in an inappropriate manner. Further discussion might be warranted on how and to what extent information on APOE testing should be provided to patients on the website of medical facilities advertising the test in order to support the well-informed self-determination of patients.

APOE

genetic testing

Study purposes and prerequisites

In this study, we conducted a website survey on the content of advertisements for APOE genetic testing. Our institutional review board approved this study (ID: 11628-(3)). Informed consent was not required because the individual patient data were not used here. All authors are academic researchers and clinical neurologists without specific conflicts of interest related to APOE genetic testing services, but are not personnel of the government office in charge of advertisement regulation. Therefore, we are not in a legal position to judge whether individual website advertisements are conducted following the current law and guidelines for medical advertisements [17]; this is a prerequisite for this study. Thus, we aimed to analyze and discuss the overall tendency of advertisements for APOE testing by medical facilities in Japan rather than to review and discuss individual websites in an identifiable manner. In addition, we will not publicize the list of medical facilities we analyzed.

Website searching

We manually searched the websites of individual medical facilities in Japan by popular Internet search engines in Japan (e.g., Google, Yahoo! Japan, and Bing) in April 2022, by the search term, which is a combination of words “APOE,” “genetic testing,” and each prefecture name in the corresponding Japanese words. Only websites written in Japanese were included, and websites for which medical facilities or their clinicians were unidentifiable were excluded in advance because descriptions on such websites are not defined as medical advertisements by the law. Identified websites were then manually examined to determine whether they introduced APOE genetic testing as one of the medical services provided in the facility. We excluded facility websites that only referred to the unspecific names of the testing (e.g., ‘genetic testing related to dementia’), those explicitly referring to APOE protein testing only, and those clarifying not providing APOE testing service. We complimented the hand search by referring to the list of “affiliated medical facilities” publicized on the websites of some commercial companies providing APOE genetic testing services for research use. One of the authors (K. S.) primarily conducted the website search procedure, which another author (Y. N.) complimented. K. S. and Y. N cooperatively determined the decision on an individual website to include in the analysis.

Extracting website characterizations

Before conducting a manual search, preferable features of the website description about the APOE testing and their definitions were prespecified, as listed in Table 1, based on the discussion between K. S. and Y. N. These website features were classified into two tiers (Tier 1 and Tier 2), based on the degree of the requirement to be included in the website description: the Tier 1 features are those considered to be more directly associated with the requirements of the law. Tier 2 features are derived from the guidelines for medical advertisement [17], dementia treatment [7], genetic testing in medical practice [18], ethical guidelines for medical research [19], or items that we consider might be important for clinicians to inform patients carefully before conducting a test.

Table 1

Configured features and their definitions
Tier - No.		Feature	Definition	Laws/guidelines we referred to
1–1	Contact information		Telephone and e-mail addresses are available on the website	Medical Care Act
1–2	Details or Costs of testing		Either Tier 2–1 or 2–2 is satisfied	Medical Care Act
	2–1	Explaining the APOE as a risk gene	Explaining that APOE testing is related to the development of AD/dementia or its risk	[17]
	2–2	Cost clarified	The cost of APOE testing by itself is clarified	[17]
1–3	Major risks and adverse reactions		Either Tier 2–3 or 2–4 is satisfied	Medical Care Act
	2–3	Notes on genetic testing	Referring to general notes on genetic testing (e.g., potential negative impact because of disclosure)	[17]
	2–4	Examination method	The examination method (e.g., blood sampling) is explained	[17]
2–5		Notes on interpreting results	Referring to the notification in interpreting APOE testing results (e.g., ‘ε4-positive does not always predict future AD development,’ or ‘ε4-negative does not always predict you are free from AD development’)	[18]
2–6		Appropriate specialists	Clinical specialists with appropriate expertise to conduct APOE testing are enrolled in the practice at the facility	[7]
2–7		No external links	The description of APOE testing on the website does not include a link to an external website for further explanations	[17]
2–8		Referring to genetic counseling	Referring to genetic counseling as per need before or after APOE testing	[7, 18, 19]
2–9		Not covered by health insurance	Clarifying the APOE testing is out-of-insurance or one of the medical checkup menu	[17]
Abbreviations: AD, Alzheimer’s disease

Definition of individual features

The author (K. S.) determined whether an individual website met the features, then K. S. and another author (Y. N.) confirmed this cooperatively. Tier 1 features (e.g., 1–2 and 1–3) were defined as eligible when their corresponding Tier 2 features were satisfied.

A broad definition of the feature ‘explaining the APOE as a risk gene’ (Tier 2–1) allowed us to regard even fundamental phrases such as ‘risk gene of AD’ or ‘genetic test related to dementia’ as eligible. The cost feature (Tier 2–2) was determined by whether the APOE testing price was shown by itself in JP¥ without being summarized with other kinds of testing.

The feature ‘Notes on genetic testing’ (Tier 2–3) was considered satisfying if the advertisement described the potential negative impact on the patients or their relatives following the disclosure of APOE testing results. The feature ‘Examination method’ (Tier 2–4): whether the sampling method (e.g., blood, hair, or saliva) is clarified. The feature ‘Notes on interpreting results’ (Tier 2–5) was deemed positive if the advertisement description included notification sentences such as ‘having APOE-ε4 allele[s] does not surely predict future development of AD’ or ‘not having APOE-ε4 allele[s] does not guarantee the individual is free from dementia’.

Features about specialists (Tier 2–6): In most outpatient clinic websites, clinicians’ names, careers, and specialties are also appealed, as far as they are allowed to advertise by law (cf. Medical Care Act, Article 6-5-3-ix). We regarded the APOE testing as explained and conducted by specialists with appropriate expertise if the clinicians enrolled in the outpatient clinic were identified on the website to be one of the certified specialists in the following expertise field: clinical neurology (as certified by the Japanese Society of Neurology: https://www.neurology-jp.org/en), dementia treatment (as certified by Japan Society for Dementia Research: https://square.umin.ac.jp/dementia/eng.html), clinical psychiatry (as certified by The Japanese Society of Psychiatry and Neurology: https://www.jspn.or.jp/modules/english/index.php?content_id=1), geriatrics medicine (as certified by The Japan Geriatrics Society: https://www.jpn-geriat-soc.or.jp/en/), or clinical neurosurgery (as certified by The Japan Neurosurgical Society: https://jns-official.jp/english/about).

Advertisement without external links (Tier 2–7): This feature was defined because the guideline on a medical advertisement does not prefer to link to other external websites, which is done to omit the explanation by the website description [17]. Genetic counseling (Tier 2–8): The guidelines on genetic testing [18, 19] require clinicians or researchers to consider the necessity of genetic counseling. At this point, counseling may not always be required in the case of APOE testing. However, we defined this question in reference to other clinical research on AD providing counseling for APOE testing [20].

Statistical analyses

All analyses were conducted using R 4.1.2. We first examined the proportion of websites that met each feature in Table 1. We then analyzed whether these websites can be classified into several clusters with similar characteristics in their description in the APOE testing advertisement using latent class analysis (LCA) [21]. Adequate separate classes were determined based on the Bayesian information criterion (BIC) value. LCA was conducted using the R package {poLCA} [22].

Overall summary

In total, we identified 220 medical facilities that posted advertisements for the provision of APOE genetic testing on their websites. Of these, 85% were small clinics, and the remaining 15% were outpatient departments of large hospitals. The top-5 locality prefectures for these facilities were Tokyo, Osaka, Kanagawa, Saitama, and Aichi, in decreasing frequency: these are the prefectures with the largest populations. The median cost of APOE testing (when clarified) was US$ 123 [IQR: 115–131] (= JP¥ 17,600 including VAT, when US$ 1 = JP¥ 143).

Features satisfied

The feature characteristics of all facilities are summarized in Table 2. Tier 1–1 was met in all facilities (100%), Tier 1–2 was also satisfied in most of the facilities (94.5%), and Tier 1–3 was met only in half of the facilities (50.0%). Among the Tier 2 features, the examination method was referred to in 50% of the facilities (Tier 2–4) whichever, regardless of blood, hair, or mucosal sampling, and notes on interpreting APOE testing results (Tier 2–5) were referred to only in 20% of the facilities. General notes on genetic testing (Tier 2–3) or genetic counseling (Tier 2–8) were rarely referred to (0.5% and 0.9%, respectively). In addition, appropriate specialists were enrolled (Tier 2–6) only in approximately one-third of all examined facilities (35.5%). However, referring to being out of insurance or being one of the medical checkups (Tier 2–9) was satisfied in many facilities (73.6%).

Table 2

Result summary of website features
Tier - No.		Feature	Satisfying websites, frequency (%)
1–1	Contact information		n = 220 (100%)
1–2	Details or Costs of testing		n = 208 (94.5%)
	2–1	Explaining the APOE as a risk gene	n = 175 (79.5%)
	2–2	Cost clarified	n = 154 (70%)
1–3	Major risks and adverse reactions		n = 110 (50%)
	2–3	Notes on genetic testing	n = 1 (0.5%)
	2–4	Examination method	n = 110 (50%)
2–5		Notes on interpreting results	n = 44 (20%)
2–6		Appropriate specialists	n = 78 (35.5%)
2–7		Not external links	n = 199 (90.5%)
2–8		Referring to genetic counseling	n = 2 (0.9%)
2–9		Not covered by health insurance	n = 162 (73.6%)
Abbreviations: BIC, Bayesian Information Criterion

Latent class analysis

Next, we conducted LCA. The number of latent classes was determined to be two based on the lowest BIC value, and Fig. 1 shows the appearance probability of each feature in classes 1 and 2. Many features of tier 2 had a similar level of appearance probabilities in classes 1 and 2, while some features (as highlighted by the daggers) showed a discrepancy between classes 1 and 2. Class 1 had higher probabilities, especially in terms of features Tier 2–1, 2–4, and 2–5, which means that these features are observed to a variable degree depending on each facility.

We analyzed the websites of 220 medical facilities advertising APOE genetic testing in Japan. As a result, most websites have satisfied the required description to post APOE testing advertisements: contact information, details, or testing costs. ‘Explanations of APOE testing itself,’ ‘the examination methods’ (e.g., blood sampling), or ‘notes on interpreting APOE results’ were described in a variable degree depending on individual facilities. ‘Notes on genetic testing’ were rarely referred to, and ‘specialists with appropriate expertise’ were considered to participate in the clinical practice in approximately one-third of these facilities providing APOE testing services. These results show that self-determination and its quality of APOE testing at some of these medical facilities in Japan can be influenced inappropriately.

In terms of the legal requirements to release restrictions on medical advertisements, contact information (Tier 1–1) or referring to details or cost of APOE testing (Tier 1–2) were satisfied in most of the facilities (100% and 94.5%, respectively). However, tier 1–2 was not 100%, which may be because of incompatibility with the current guidelines on medical advertisements that were updated recently (i.e., in April 2021) [17] or our survey rule in the manual search. Risks or adverse reactions (Tier 1–3) were met only in half of the facilities, which may be because of two reasons: the potential risk following the disclosure of the results is not always sufficiently recognized, and the degree of invasion in specimen sampling for APOE testing (e.g., sampling of blood, hair, or buccal mucosa) is limited. According to the Medical Care Act article translated into English by the Ministry of Justice, the legal requirements to release restrictions require including “information on particulars pertaining to major risks and adverse reactions, etc., by medical care not covered by health insurance.” If the risk of APOE disclosure is unrecognized or ignored by clinicians, they may not be considered that they should describe its risks and adverse effects on their websites.

Specialists with appropriate expertise were considered to have been enrolled in approximately one-third of the facilities advertising APOE testing (Tier 2–6). However, this may even be underestimated, as we determined the enrollment of specialists merely by the listed names of clinicians on the website, irrespective of the actual working conditions. Furthermore, such a limited proportion of enrolled specialists raises concerns about whether sufficient explanation about the significance of the testing is provided and whether notes on genetic testing (Tier 2–3) are also provided for patients before and when disclosing the results. In addition, we suspect from the current result that specialists with expertise in dementia treatment may be more reluctant to conduct APOE testing than those without, based on the relative proportion of enrolled specialists versus non-specialists and their background clinician population in Japan. The clinical practice guidelines for dementia will explain this, which do not recommend routine APOE testing [7], and another guideline for genetic testing that recommends APOE testing after considering its validity and usefulness [18, 19].

Genetic counseling is rarely referred to (Tier 2–8: 0.9%). It is indeed not required to be posted by the guideline of medical advertisements, and is also not always required to be provided in the actual practice by the guidelines on genetic testing [18, 19] where clinicians or researchers are to consider the necessity of genetic counseling. However, because the proportion of specialists enrolled was relatively low, the necessity may not always be considered appropriately, which is another matter of concern.

The advertisement on APOE testing is occasionally accompanied by descriptions appealing to its significance, such as“APOE genetic testing is useful in understanding the future risk of dementia to prepare for its prevention.” However, we did not analyze such appealing expressions here. The effect of drug intervention with DMT to prevent/suppress AD or dementia, or the effect of the multifactorial intervention, including management of vascular risk factors (e.g., hypertension, diabetes, and dyslipidemia), nutritional guidance, and exercise training [23, 24] have not always been established so far. We are concerned that advertisements appealing to the significance of APOE testing may be overstated, depending on how they are described.

Our study had several potential shortcomings. First, we do not know how APOE testing is explained and conducted in actual clinical practice in each facility. The poor explanation in the website advertisement does not always mean that the information provided to patients is poor. In addition, we examined facilities that made advertisements on their websites, so we could not examine those providing the testing service without doing website advertisement. In addition, this study focuses on the appropriateness of the advertisement, which has limitations in its scope in discussing how to support well-informed self-determination on whether to take the test.

Second, although we had to rely on publicized certifications to distinguish individual clinicians’ expertise, clinicians with a certification in the specific expertise areas related to dementia treatment may not always be familiar with APOE testing. In addition, even in the case of clinicians without specific certification testing, the actual conditions may differ between general internal medicine clinics and out-of-insurance beauty clinics, which we could not examine here.

Although current clinical practice guidelines do not routinely recommend APOE testing in medical practice, we consider that APOE testing might become more widely used in the near future. It can facilitate health-related behavioral changes in individuals with the ε4 allele[s] [9], such as managing potentially modifiable risks of AD (e.g., smoking, social isolation) [25], facilitating the recruitment of at-risk individuals to AD prevention trials [26–28], or stratifying patients according to the risk of developing ARIA during DMT treatment [2]. The utility and considerations of APOE testing from these aspects should also be evaluated in the future [4].

In conclusion, our analysis revealed that some features of website advertisements were described differently depending on the individual facilities. Additionally, specialists with appropriate expertise were considered to participate in the practice in only approximately one-third of these facilities. These results indicate that self-determination of whether to take APOE testing can be influenced inappropriately at some medical facilities in Japan, as far as we suspect based on the advertisement descriptions. Therefore, it is necessary to have further discussion on how and to what extent information on APOE testing should be provided to patients on medical facility websites.

Alzheimer’s disease

ARIAs

amyloid-related imaging abnormalities

DMT

disease-modifying therapy

DTC

direct-to-consumer

Ethics approval and consent to participate: This study was approved by the University of Tokyo Graduate School of Medicine Institutional Ethics Committee (ID: 11628-(3)). Informed consent was not required for this type of study.

Consent for publication: Not applicable.

Availability of Data and Materials: All data generated or analysed during this study are included in the supplementary information files. We anonymized the names of medical facilities we analyzed, to avoid identifiability of the facilities.

Competing interests: The authors declare that they have no competing interests.

Funding: This study was supported by AMED Grant Numbers JP21dk0207048 (T.I: Takeshi Iwatsubo) and JP21dk0207054 (Y.N), and JSPS KAKENHI Grant Number 21K20891 (K.S).

Author’s contributions: KS made a study concept and design, acquired and analyzed the data, interpreted the results, and drafted the manuscript. YN acquired and analyzed the data, interpreted the results, and drafted the manuscript. RI, AI, TI (Takeshi Ikeuchi), and TI (Takeshi Iwatsubo) have contributed to the interpretation of the results and revision of the manuscript.

Acknowledgements: Not applicable.

Author’s information: Not applicable.

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No competing interests reported.

apoedata.csv

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Advertisement by medical facilities as an opportunity of APOE genetic testing in Japan: a website analysis

Status:

Version 1

Abstract

Figures

Background

Methods

Study purposes and prerequisites

Website searching

Extracting website characterizations

Definition of individual features

Statistical analyses

Results

Overall summary

Features satisfied

Latent class analysis

Discussion

Abbreviations

Declarations

References

Additional Declarations

Supplementary Files

Status:

Version 1