Direct-to-consumer Research Articles

The new digital music marketing ecosystem: artist direct

New digital formats, media fragmentation and the evolution of complex consumer behaviour continue to disrupt the music industries. There are substantial gaps in academic research in terms of this newly emerging digital music marketing ecosystem. Even less for independent artists who run Artist Direct (AD) to-consumer business models and considered one of the fastest growing segments in the global recording industry. This paper constructs a digital music marketing ecosystem for those actors establishing market presence at the start of the industry value chain. Managing small micro music businesses, these artists collectively represent a significant economic segment and are an important supply chain source for larger intermediaries such as record labels who monitor the segment and sign artists from it. The findings consider the actors, entities, systems, and processes operating in this new business ecosystem. A multimethod research design was used combining data sets from practice-led research; a concurrent systematic literature review, as well as an ethnographic analysis involving in-depth interviews (n = 14) with music industry professionals. The outcome was the construction of a digital music marketing ecosystem for this AD segment advancing marketing insights for the music industries but also with implications for the creative and cultural industries more broadly.

Direct-to-consumer STI screening methods: Preferred communication sources and channels among young adult women.

Direct-to-consumer (DTC) sexually transmitted infection (STI) screening methods utilize self-collected samples in a non-clinical setting. DTC methods may reach a population of women who avoid screening due to stigma, privacy concerns, or who lack access to clinical care. Little is known about the salient dissemination approaches to promote these methods. The study's purpose was to identify preferred sources and communication channels for information about DTC methods among young adult women. Participants were sexually active 18-24-year-old college women at one university, recruited via purposive sampling using campus email, list-servs, and campus events to participate in an online survey (n = 92). Interested participants were invited to participate in in-depth interviews (n = 24). Both instruments were guided by the Diffusion of Innovation theory to identify relevant communication channels. Survey participants ranked healthcare providers as their preferred source of information, followed by the internet and college- and university-based resources. Race was significantly associated with the ranking of partners and family members as information sources. Interview themes focused on healthcare providers legitimizing DTC methods, using the internet and social media to increase awareness, and linking DTC method education to other services provided by the college. This study revealed common information sources that college-age women may utilize when researching DTC method information and potential channels and strategies for DTC uptake and dissemination. Utilizing trusted sources including healthcare providers, trusted websites, and established college resources as dissemination channels may be beneficial to increase the awareness and use of DTC methods for STI screening.

PO-04-178 E-COMMERCE DIRECT-TO-CONSUMER RHYTHM MONITORING DEVICES: CLEARED FOR LANDING OR CLEAR AS MUD?

Direct-to-consumer (DTC) digital health products, especially personal ECG monitoring devices, have grown exponentially. Marketing studies show that ∼70% of consumers never click beyond the 1st search engine results page (SERP) of an online e-commerce (e-comm) site and frequently purchase from the 1st few products listed. Whether the majority of personal ECG devices available on e-comm platforms in the United States are FDA cleared or validated is unknown. To characterize DTC personal ECG monitoring devices on a popular e-commerce website. The most popular U.S. e-commerce website, Amazon.com (Amazon.com, Inc., Seattle, WA), was searched for “personal ECG.” Results on the 1st SERP were ranked in order of position on the webpage. Non-heart monitoring devices & duplicates were excluded. Devices were analyzed for name, type of analysis offered, presence of an external website, presence of non-medical use disclaimers, and for FDA clearance statement in the e-comm device description or on an external website. Results were cross-referenced to the FDA 510(k) clearance database and to PubMed for validation studies. A total of 61 devices were listed on the 1st SERP, of which 21 (43%) were excluded. The remaining 40 devices were: 23 (58%) ECG-capable, 7 (18%) PPG-rhythm capable, and 10 (25%) heart-rate only. Seven (70%) of the 1st ten devices on the SERP could not be found in the FDA 510(k) database. Of the 30 ECG or PPG-rhythm capable devices, 14 (47%) were not listed in the FDA 510(k) database: 2 advertised FDA clearance on an external webpage but were not listed in the FDA 510(k) database, 11 (79%) offered rhythm analysis with 2 (14%) also offering automatic QTc, 6 (43%) had a clearly stated non-medical use disclaimer in the e-comm description. Of the 16 (53%) devices confirmed to have FDA 510(k) clearance, 4 (25%) stated this clearly in the e-comm description. Validation studies were found for 13 (81%) of FDA-cleared vs 1 (7%) of non-FDA-cleared devices. Nearly half of DTC “personal ECG” devices on the 1st SERP of a popular e-commerce site may not be FDA cleared, do not have non-medical use disclaimers and the majority do not have validation studies. Also, few FDA-cleared devices are clearly labeled as such on the site. This can be potentially confusing and misleading for patients and consumers. Education to increase awareness and health policies for regulation are needed for this issue.

Sosialisasi Gema Cermat (Gerakan Masyarakat Cerdas Menggunakan Obat) dengan Memasyarakatkan “Tanya 5 O”

Public knowledge of self-medication is crucial, and one of the challenges faced is the lack of awareness regarding this practice. Irrational self-medication can lead to harmful consequences, such as incorrect treatment due to inaccurate self-diagnosis. Contributing factors include biased drug advertisements in the media and inadequate information from healthcare professionals. Community engagement is one of the collaborative sharing programs initiated by the Government, known as the Gema Cermat (Smart Community Using Medicines Movement), which includes the promotion tagline "Ask 5 O." This community engagement program aims to enhance the independence of the public in selecting, obtaining, using, storing, and disposing of drugs appropriately, thus promoting rational drug use within society. The target audience for this program was the teenage group of Sekaa Teruna Teruni Panji Semerang in Banjar Sembung Meranggi, Sembung Gede Village, Bali. The results of this community engagement program demonstrated a significant change in participants' knowledge, as assessed through pre- and post-survey questionnaires analyzed using paired T-Test, showing a p-value of 0.000 < 0.005. The findings highlight the beneficial impact of the Gema Cermat program in improving participants' knowledge. Going forward, it is recommended to conduct more frequent community engagement activities across various segments of society to support rational drug use.

Zero or 18

Zero or 18

Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers.

Healthcare providers (HCPs) often encounter clinical trial results in the form of data displays in prescription drug promotions. Information conveyed in data displays vary in their presentation and complexity. This study describes characteristics of data displays in prescription drug advertising targeted to HCPs. This study characterized the content of 140 data displays in 98 unique print advertisements from 2009 to present and identified in AdPharm, an online database of pharmaceutical advertisements. Two reviewers independently coded the advertisements for characteristics (κ = 0.85) including complexity, format, and quality. About one-third (32%) of the advertisements contained multiple data displays (range 2 to 6) and 44% showed clinical data from oncology trials; other disease domains were mental and behavioral health (14%), rheumatology and autoimmune disorders (8%), endocrinology (7%), cardiology (6%), infectious disease (6%), pulmonology and allergy (4%), and others (< 2% each). About one-half (51%) of displays were classified as "simple" which included "pseudographs" and basic tables or charts. "Complex" displays appeared as survival curves, line graphs, or bar graphs with complex features. Most complex displays included a comparator drug (90%), plain language restatement of the key finding (93%) and disclosure statements (91%) with additional study details, although their placement varied. Complex displays were of high quality, according to our selected indicators; our analysis found no data distortion or errors. Data displays in prescription drug advertising are often highly complex. Future research assessing understanding of data displays and the potentially beneficial effect of disclosures and other features is warranted.

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss.

Hearing aids are the most commonly used treatment for people with age-related hearing loss, however, hearing aid uptake is low, primarily due to high cost of the device, stigma, and a lack of perceived need. To address accessibility and affordability issues, the U.S. Food and Drug Administration created a new over-the-counter (OTC) hearing aid category. Various types of hearing devices are available for both individuals with hearing loss and for those with normal hearing, as hearing enhancement devices. Hearing aids (i.e., prescription hearing aids, self-fitting OTC hearing aids, and pre-set OTC hearing aids) are regulated by the FDA. The purpose of this article is to (a) provide a summary of existing research on direct-to-consumer (DTC) hearing devices such as Personal Sound Amplification Products (PSAPs) that informs OTC service delivery models; (b) provide an update on existing and ongoing randomized controlled trials on currently marketed OTC hearing aids; and (c) highlight the need for immediate research on OTC hearing aids and service delivery models to inform policy and clinical care. It remains to be seen what effect OTC hearing aids have on improving the uptake of hearing aids by individuals with mild-to-moderate hearing loss. However, there is scant research on all aspects of OTC hearing aids that are currently on the market. We conclude that high quality independent research must be prioritized to supplement evidence provided by the OTC hearing aid manufacturers for regulatory approval purposes.

Polygenic Scores in the Direct-to-Consumer Setting: Challenges and Opportunities for a New Era in Consumer Genetic Testing.

Direct-to-consumer (DTC) genetic tests have generated considerable scholarly attention and public intrigue. Although the current consumer genetic testing regime relies on the reporting of individual variants of interest to consumers, there has recently been interest in the possibility of integrating polygenic scores (PGS), which aggregate genetic liability for disease across the entire genome. While PGS have thus far been extensively explored as clinical and public health tools, the use of PGS in consumer genetic testing has not yet received systematic attention, even though they are already in use for some consumer genetic tests. In this narrative review, we highlight the ethical, legal, and social implications of the use of PGS in DTC genetic tests and synthesize existing solutions to these concerns. We organize these concerns into three domains: (1) industry variation; (2) privacy and commercialization; and (3) patient safety and risk. While previously expressed concerns in these domains will remain relevant, the emergence of PGS-based DTC genetic tests raises challenges that will require novel approaches.

Prescription drug advertising and drug utilization: The role of Medicare Part D

This paper examines how direct-to-consumer advertising (DTCA) for prescription drugs influences utilization by exploiting a large and plausibly exogenous shock to DTCA driven by the introduction of Medicare Part D. Part D led to larger increases in advertising in geographic areas with higher concentrations of Medicare beneficiaries. We examine the impact of this differential increase in advertising on non-elderly individuals to isolate advertising effects from the direct effects of Part D. We find that exposure to advertising led to large increases in treatment initiation and improved medication adherence. Advertising also had sizeable positive spillover effects on non-advertised generic drugs. Our results imply significant spillovers from Medicare Part D on the under-65 population and an important role for non-price factors in influencing prescription drug utilization.

How message appeals and prior product use influence information processing, risk perceptions, trust, attitudes, and genetic test purchase intentions.

Within the direct-to-consumer (DTC) genetic test industry, attracting customers can be difficult especially due to the highly sensitive nature of these products. How these tests are communicated to consumers may be one avenue in which companies can impact customer purchase intentions. A 2 (message sidedness: one-way vs. two-way refutational) x 2 (hedging: present vs. absent) between-subjects experiment was conducted to understand how message features and prior product use influence information processing, risk and trust perceptions, and attitude toward the genetic test, which in turn, may influence direct-to-consumer (DTC) genetic test purchase intentions. Results demonstrated that having used a genetic test in the past predicted participants' trust in the company, information processing, and risk judgments; however, among those who used a genetic test, viewing a message that included hedging tended to increase their trust in the message. Trust in the message and company, information processing, and risk judgments significantly predicted participants' attitudes toward genetic testing, which in turn predicted their purchase intentions. The results suggest that in the context of DTC genetic test messaging, practitioners should strive to increase consumer trust in the message and the company and facilitate information processing, and they should work to diminish perceived risk. These results suggest opportunities for identifying other message features that may influence message and company trust, information processing, risk judgments, and attitudes related to DTC genetic testing.

Direct-to-Consumer Recruitment Methods via Traditional and Social Media to Aid in Research Accrual for Clinical Trials for Rare Diseases: Comparative Analysis Study.

Recruitment into clinical trials is a challenging process, with as many as 40% of studies failing to meet their target sample sizes. The principles of direct-to-consumer (DTC) advertising rely upon novel marketing strategies. The ability to reach expansive audiences in the web-based realm presents a unique opportunity for researchers to overcome various barriers to enrollment in clinical trials. Research has investigated the use of individual web-based platforms to aid in recruitment and accrual into trials; however, a gap in the literature exists, whereby multiple mass communication platforms have yet to be investigated across a range of clinical trials. There is a need to better understand how individual factors combine to collectively influence trial recruitment. We aimed to test whether DTC recruitment of potentially eligible study participants via social media platforms (eg, Facebook [Meta Platforms Inc] and Twitter [Twitter Inc]) was an effective strategy or whether this acted as an enhancement to traditional (eg, email via contact registries) recruitment strategies through established clinical research sites. This study tested multiple DTC web-based recruitment efforts (Facebook, Twitter, email, and patient advocacy group [PAG] involvement) across 6 national and international research studies from 5 rare disease consortia. Targeted social media messaging, social media management software, and individual study websites with prescreening questions were used in the Protocol for Increasing Accrual Using Social Media (PRISM). In total, 1465 PRISM website referrals occurred across all 6 studies. Organic (unpaid) Facebook posts (676/1465, 46.14%) and Rare Diseases Clinical Research Network patient contact registry emails (461/1465, 31.47%) represented the most successful forms of engagement. PRISM was successful in accumulating a 40.1% (136/339) lead generation (those who screened positive and consented to share their contact information to be contacted by a clinical site coordinator). Despite the large number of leads generated from PRISM recruitment efforts, the number of patients who were subsequently enrolled in studies was low. Across 6 studies, 3 participants were ultimately enrolled, meaning that 97.8% (133/136) of leads dropped off. The results indicate that although accrual results were low, this is consistent with previously documented challenges of studying populations with rare diseases. Targeted messaging integrated throughout the recruitment process (eg, referral, lead, and accrual) remains an area for further research. Key elements to consider include structuring the communicative workflow in such a way that PAG involvement is central to the process, with clinical site coordinators actively involved after an individual consents to share their contact information. Customized approaches are needed for each population and research study, with observational studies best suited for social media recruitment. As evidenced by lead generation, results suggest that web-based recruitment efforts, coupled with targeted messaging and PAG partnerships, have the potential to supplement clinical trial accrual.

Telemedicine Visits to Children During the Pandemic: Practice-Based Telemedicine Versus Telemedicine-Only Providers.

In March 2020, regulatory and payment changes allowed "brick and mortar" pediatric practices to offer practice-based telemedicine for the first time, joining direct-to-consumer (DTC) telemedicine vendors in the ability to offer visits for common acute pediatric concerns via telemedicine. We sought to characterize the relative contribution of practice-based telemedicine versus commercial DTC telemedicine models in provision of children's telemedicine from 2018 through 2021. Using January 2018 to September 2021 data from Optum's de-identified Clinformatics® Data Mart Database, we identified telemedicine visits by children ≤17, excluding preventive visits and visits to specialists, emergency departments, and urgent care. Among included visits, we defined "telemedicine-only" providers as those with ≥80% of visits via telemedicine and practice-based telemedicine providers as those with ≤50% of visits via telemedicine. We then described the telemedicine visit volume and diagnoses for these categories overall and per 1000 children per month. From January 2018 to February 2020, telemedicine-only providers accounted for 57,815 telemedicine visits (90.8%), while practice-based telemedicine accounted for 4192 telemedicine visits (6.6%). From March 2020 to September 2021, telemedicine-only providers accounted for 38,282 telemedicine visits (6.1%), while practice-based telemedicine accounted for 555,125 telemedicine visits (88.2%). Per month, telemedicine visits to practice-based telemedicine providers increased from pre-pandemic to pandemic periods (0.1 vs 12.9 visits per 1000 children/month), while telemedicine visits to telemedicine-only providers occurred at a similar rate from pre-pandemic to pandemic periods (0.92 vs 0.96 visits per 1000 children/month). We observed a large increase in telemedicine visits during the pandemic, with the growth in visits exclusively occurring among visits to practice-based telemedicine providers as opposed to telemedicine-only providers.

Implied Claims in Drug Advertising: A Review of Recent Literature and Regulatory Actions

ABSTRACT Federal agencies and self-regulatory bodies help to ensure prescription and nonprescription drug promotion contains accurate information; however, false or misleading claims may cause people to have inaccurate perceptions of a drug and inhibit their ability to make informed decisions. We conducted a systematic review assessing evidence from 2012–2021 on how consumers and healthcare providers (HCPs) interpret claims made indirectly or through inference (implied or implicit claims) as well as synthesizing prescription and nonprescription drug advertising claims that have been the subject of regulatory actions from 2017–2021. Our search identified 16 studies from the peer-reviewed literature and 26 letters or case reports issued by the Food and Drug Administration (FDA) or National Advertising Division (NAD). Results from peer-reviewed studies suggest that implied claims can result in inferences that may not be warranted by the material facts about the drug. Perceptions of a drug’s efficacy and, to a lesser extent, risk, are influenced by implied and explicitly false claims in prescription drug promotion. Claims related to implied superiority and overstatement of efficacy were the most prevalent claims flagged for review and examined in the literature. These types of claims were also the subject of many of the compliance actions by the FDA and case reports from the NAD. More research is needed to understand how people interpret varying types of implied claims and the impact of such claims on key outcomes. From a policy standpoint, understanding how people interpret implied claims can inform how the FDA approaches these claims in the marketplace.

Short- and intermediate-term impact of DTC telemedicine consultations on subsequent healthcare consumption

AimThe use of direct-to-consumer (DTC) telemedicine consultations in primary healthcare has increased rapidly, in Sweden and internationally. Such consultations may be a low-cost alternative to face-to-face visits, but there is limited evidence on their effects on overall healthcare consumption. The aim of this study was to assess the short- and intermediate-term impact of DTC telemedicine consultations on subsequent primary healthcare consumption, by comparing DTC telemedicine users to matched controls in a Swedish setting.MethodsWe constructed a database with individual-level data on healthcare consumption, for all residents of Region Stockholm in 2018, by linking national and regional registries. The study population included all individuals who had ≥ 1 physician consultation (telemedicine or face-to-face) during the first half of 2018. DTC telemedicine users were matched 1:2 to controls who were non-users of DTC telemedicine but who had a traditional face-to-face consultation during the study period. The matching criteria were diagnosis and demographic and socioeconomic variables. An interrupted time series analysis was performed to compare the healthcare consumption of DTC telemedicine users to that of the control group.ResultsDTC telemedicine users increased their healthcare consumption more than controls. The effect seemed to be mostly short term (within a month), but was also present at the intermediate term (2–6 months after the initial consultation). The results were robust across age and disease groups.ConclusionThe results indicate that DTC telemedicine consultations increase the total number of physician consultations in primary healthcare. From a policy perspective, it is therefore important to further investigate for which diagnoses and treatments DTC telemedicine is suitable so that its use can be encouraged when it is most cost-efficient and limited when it is not. Given the fundamentally different models for reimbursement, there are reasons to review and possibly harmonise the incentive structures for DTC telemedicine and traditional primary healthcare.

Direct-to-Consumer Genetic Test and Lifestyle Questionnaire Analysis of Body Mass Index and Body Fat Percentage in a Large Korean Population

Background: Direct-to-Consumer (DTC) genetic testing provides genetic risk to consumers and motivates consumers to take care of their own customized health care. In 2018, we developed and provided a DTC genetic testing service (GENESTART™) in collaboration with Herbalife Korea Co. Ltd. Methods: The analyzed dataset consisted of the body fat percentage (BFP), body mass index (BMI), 31 genetic polymorphism genotypes, and responses to 19 questionnaire items of 24,447 individuals. The genetic main effects for BFP and BMI were examined by linear regression analysis, and the interaction effects were examined using a generalized linear model that controlled age and sex as covariates. Results: In the case of BFP, the sample average was 31.47% overall, 24.76% for men, and 32.79% for women, showing that men had an average BFP that was 8 percentage points lower than that of women. The average BMI was 25.38 overall, 26.45 for men, and 25.17 for women, showing that men had an average BMI of 1.2 kg/m2 higher than that of women. The FTO and MC4R genes, well-known obesity markers, showed a significant correlation with both phenotypes, and the BDNF gene, which is related to stress obesity, showed a highly significant association with BMI but only a weak association with BFP. Among the remaining genes, TRIB1, ABCA1, MYL2, G6PC, GCKR, GLIS3, CYP17A1, HECTD4, and NT5C2 genes showed significant associations with the obesity-related phenotypes. In this study, we found four interaction results for BFP (ABO and fruits, CYP1A2 and sugary foods, FTO and muscle exercise, MC4R and vitamins) and five interactions for BMI (MC4R and proteins, CSK and fruits, MC4R and calcium, DGKB and calcium, CSK and water). Conclusions: This study is expected to enable the provision of personalized and accurate solutions for BFP and BMI management to customers who have undergone genetic testing.

Measuring high-risk parents' opinions about direct-to-consumer genetic testing for adult-onset inherited cancer syndromes in their adolescent and young adult children.

Neither direct-to-consumer (DTC) genetic testing nor predictive genetic testing for adult-onset conditions is recommended for minor children due to ethical concerns and low clinical utility. However, parents with pathogenic variants (PVs) in disease-causing genes may be interested in pursuing genetic testing that includes the familial PV for their children. The Pediatric Testing Attitudes Scale (P-TAS) was previously developed to examine high-risk parents' opinions about pediatric BRCA genetic testing for adult-onset breast/ovarian cancer. Here, the psychometric properties of the P-TAS were examined in a new sample of N=126 parents (M age=47.2 years) with PVs in a more complete set of cancer risk genes represented on DTC panel tests. The mean score on the P-TAS was 44 out of a maximum score of 60, indicating that a majority of parents generally held favorable opinions about testing their children for adult-onset inherited cancer syndromes. The internal consistency of the full scale was high (α=0.91). A factor analysis identified two-component scales, labeled Attitudes and Beliefs (α=0.93) and Decision Making and Communication (α=0.83). In a multivariable regression model, P-TAS co-factors accounted for 34% of variance in parental opinions, including the frequency of prior family communication about cancer and the likelihood of utilizing DTC genetic testing with children (R2 =0.34, p < 0.001). Results suggest that the P-TAS remains a reliable measure to assess high-risk parents' opinions about pediatric DTC genetic testing for adult-onset conditions, with promising validity. Applications of the P-TAS include informing genetic counseling practice, pediatric medical care, and policy guidelines surrounding DTC genetic testing.

Direct-to-consumer testing- benefits for consumers, people with disease and public health.

Direct-to-consumer (DTC) tests can be defined as any in-vitro diagnostic (IVD) test or, more broadly, any medical test using an IVD or medical device, that is marketed directly to consumers without involvement of a health care provider (HCP). Examples are pregnancy tests, alcohol breath tests, blood pressure measurements (medical device), coagulation tests (INR), self-monitoring of blood glucose, continuous glucose monitoring (medical device), HIV tests, HPV tests, SARS-CoV-2 antigen tests, or genetic tests. DTC tests fulfil various customer needs such as making rapid decisions (e.g. glucose monitoring for insulin dosing, SARS-CoV-2 antigen test, hormone test identifying fertile days, alcohol test), monitoring chronic conditions between consultations (e.g. diabetes, lipidaemia, hypertension), saving time and reducing consultations (e.g. INR, SARS-CoV-2 antigen test, blood pressure monitoring), screening for disease when no symptoms are present (e.g. occult blood, cholesterol, triglycerides, SARS-CoV2 antigen test), or maintaining privacy (e.g. pregnancy test, HIV test, HPV test, certain genetic tests). Further, DTC tests can reduce cost and expand access to care in countries with limited resources and can support healthcare systems in extraordinary circumstances such asapandemic. Valid concerns about DTC testing need to bedescribed, addressed and resolved with the help of authorities and regulators in collaboration with HCP and should not detract from the advantages DTC tests can provide. HCP should play a more prominent role in educating the public through mass media and social media on the proper use of DTC tests and help to pinpoint problem areas.

Searching for secrets, searching for self: Childhood adversity, self-concept clarity, and the motivation to uncover family secrets through direct-to-consumer genetic testing.

Direct-to-consumer (DTC) genetic tests have become an attractive product for those hoping to gain insight into their health, ancestry, and biological relatedness. In some cases, test results are unexpected, and lead to the revelation of previously undisclosed family secrets. A subset of individuals may pursue testing explicitly for this purpose; however, the psychosocial processes underlying this motivation remain unexamined. Grounded in the literature on family secrecy, trauma, and the development of self-concept, we tested a hypothesized mediation model to provide insight into this motivation among a sample of 433 individuals in pursuit of DTC genetic testing. In line with the documented association between maladaptive family communication patterns and trauma exposure in childhood, we found that exposure to adverse childhood experiences was associated with the motivation to pursue DTC genetic testing for the purpose of uncovering family secrets. We also found evidence of an indirect effect through reduced self-concept clarity. These findings suggest that impaired identity formation processes may have played a role in transmitting the effect. Furthermore, the findings highlight a novel way in which family histories may contribute to DTC genetic testing motivations. Future examination of these and other psychosocial phenomena that contribute to DTC genetic testing will be crucial to consider as the tests become increasingly accessible, and as the information they can provide becomes increasingly comprehensive. Findings from this line of research could help to identify for whom and under what conditions DTC genetic testing benefits well-being, and the conditions under which the act of testing and receipt of results could have adverse psychosocial effects. These insights will be of interest to genetic counselors working in the field of DTC genetic testing, and those working with individuals and families affected by unexpected test results.

An Evaluation of a Proposed Direct-to-Consumer (DTC) Model of Hearing-Health Care.

The introduction of over-the-counter hearing aids (HA) has resulted in a new hearing-health-care pathway. The aim of this study was to assess if individuals could navigate four steps in a direct-to-consumer (DTC) HA delivery model, which include self-identification of hearing difficulties and risk for ear disease, self-selection of device, self-fitting and programming of device, and self-management. Fifty-two participants self-reported their degree of hearing loss and risk for ear disease. Participants were provided with three preselected DTC-HA Web sites and asked to select a device. Using the manufacturer's instructions, they then self-fit and programmed the device they chose. Participants' HA use and handling skills were evaluated using the Practical HA Skills Test-Revised (PHAST-R) and the Measure of Audiologic Rehabilitation Self-efficacy for Hearing Aids (MARS-HA). Real-ear verification was completed to determine how closely they programmed their device to NAL-NL2 targets. Agreement between self-reported degree of hearing loss and ear disease was determined from an audiological and ear disease risk assessment, respectively. Seventy-five percent of participants reported that their perceived hearing loss was in the mild-to-moderate range. Ninety-three percent of participants who were identified to be at risk for ear disease did not self-report being at risk. PHAST-R scores ranged from 45 to 100% and were significantly impacted by manufacturer instructions. Only 24% of fittings were within the accepted tolerances for prescriptive targets. No participant was able to successfully navigate all four steps in the proposed DTC-HA model. Participants with hearing thresholds ≤ 25 dB HL and participants who were identified as being at risk for ear disease, but did not self-report the risk, both said they would purchase a DTC-HA as a treatment option. Manufacturer instructional materials can impact setup and programming of a DTC device. DTC models of hearing-health care may require additional consumer support.

An Online Investigation Into Direct-to-Consumer Men's Health Clinics: The Who, What, and Where

ObjectiveTo characterize direct-to-consumer (DTC) men's health clinics by reviewing their online content. Increasing numbers of patients are seeking treatment for erectile dysfunction (ED) and hypogonadism from DTC “men's health” clinics. Treatments are often used off-label, with lack of transparency of provider credentials and qualifications. MethodsWe identified DTC Men's Health Clinics in the United States by internet search by state using the terms, “Men's Health Clinic,” and “Low T Center.” All stand-alone clinics were reviewed. ResultsTwo hundred and twenty-three clinics were reviewed, with 147 (65.9%) offered ED treatments and 196 (87.9%) offering testosterone replacement, and 120 (53.8%) offering both ED treatment and testosterone replacement. Of those clinics offering ED treatments, 93 (63.3%) advertised shockwave therapy and 84 (57.1%) PRP therapy. There were 56 (38%) who offered shockwave therapy and PRP. ICI was significantly more likely to be offered if there was a urologist on staff (p <.001).Clinic providers represented 20 different medical and alternative medicine specialties. Internal medicine was most common (17.4%), followed by family medicine (11.1%). A nonphysician (nurse practitioner or physician assistant) was listed as the primary provider in 10 clinics (4.5%) and 45 clinics (20.1%) did not list their providers. Urologists were listed as the primary provider in 10.3% of clinics. A naturopathic provider was listed as a staff member in 22 (11.6%) of clinics. ConclusionThere is significant heterogeneity and misinformation available to the public regarding men's health. Familiarity with and insight into practice patterns of “men's health” clinics will help provide informed patient care and counseling.