????10年來，無數(shù)創(chuàng)業(yè)者在世界各地建立了數(shù)字健康公司。目前，市面上的健康類App超過10萬個(gè)，目的都是讓我們變的更健康。然而，其中有多少家公司能拿出確鑿證據(jù)來支持自己的保健方法呢？Omada Health公司聯(lián)合創(chuàng)始人兼首席執(zhí)行官肖恩·達(dá)菲認(rèn)為這樣的公司不多。Omada Health也是一家數(shù)字健康公司，它開發(fā)的軟件針對可能患慢性病的人群。達(dá)菲說：“這樣的公司仍很罕見。”

????實(shí)際上，由于涉及數(shù)字健康產(chǎn)品和服務(wù)的臨床和經(jīng)濟(jì)證據(jù)是如此匱乏，以至于有人專門建立了一家初創(chuàng)型企業(yè)來解決這個(gè)問題。這就是Evidation Health。該公司CEO黛博拉·基爾帕特里克說，他們的工作就是分析數(shù)字健康公司的宣傳廣告，因?yàn)榻?jīng)科學(xué)檢驗(yàn)的數(shù)字保健方法少之又少。

????基爾帕特里克表示：“我不會說這些公司無法為自己宣稱的東西提供依據(jù)。它們只是還沒有[予以證明]。這些公司能否做到這一點(diǎn)還有待觀察?！?/p>

????她認(rèn)為，數(shù)字健康行業(yè)缺乏依據(jù)的原因是在這方面幾乎沒有投入過時(shí)間和資金，也幾乎沒有相關(guān)的專業(yè)知識。她說：“公平地講，數(shù)字健康這個(gè)行業(yè)還相當(dāng)年輕。”

????基爾帕特里克說，目前許多數(shù)字健康公司仍在走向成熟，它們拿到了天使投資，或者正在進(jìn)行A輪或B輪融資；這個(gè)行業(yè)也仍在探索提高保健效果意味著什么。建立這些公司的創(chuàng)業(yè)者往往來自消費(fèi)品行業(yè)，而不是醫(yī)療保健行業(yè)。因此，他們知道證據(jù)很重要，但不知道怎樣找到證據(jù)。

????臨床試驗(yàn)是證明健康干預(yù)措施行之有效的標(biāo)準(zhǔn)途徑，但其費(fèi)用之昂貴令人望而卻步。同時(shí)，這項(xiàng)工作通常需要一個(gè)資源豐富并且能接觸到病人的合作伙伴，比如醫(yī)院。但醫(yī)療保健機(jī)構(gòu)往往不愿意跟沒有證據(jù)支持的小公司合作，而找不到合作伙伴的小公司又無法拿出證據(jù)。此外，作為臨床試驗(yàn)場所，醫(yī)院習(xí)慣于就此收取費(fèi)用；初創(chuàng)公司則希望醫(yī)院在試用其解決方案時(shí)付錢，這也是一個(gè)障礙。

????基爾帕特里克指出，消費(fèi)型科技的市場潛力在于得到消費(fèi)者使用。但在醫(yī)療保健領(lǐng)域，推動產(chǎn)品或服務(wù)得到應(yīng)用的經(jīng)常是步調(diào)緩慢的醫(yī)療機(jī)構(gòu)、保險(xiǎn)公司和制藥企業(yè)。她說：“這個(gè)應(yīng)用過程要復(fù)雜得多，規(guī)模也大得多?！?/p>

????非營利醫(yī)療服務(wù)機(jī)構(gòu)Ochsner Health System首席臨床轉(zhuǎn)化官理查德·米拉尼博士表示，醫(yī)院對數(shù)字健康技術(shù)的采用受多個(gè)因素影響。醫(yī)療保健領(lǐng)域需要顛覆，但必須小心地顛覆。

????米拉尼博士說：“你得對自己采用的技術(shù)可靠而且精確這件事有把握。這確實(shí)是個(gè)問題。如果能拿出一些科學(xué)數(shù)據(jù)，或者經(jīng)過同行檢驗(yàn)的數(shù)據(jù)來予以證明，事情當(dāng)然會變得容易一些。”

????在風(fēng)險(xiǎn)投資方GE風(fēng)投和醫(yī)療機(jī)構(gòu)Stanford Health Care的支持下，Evidation Health把數(shù)字健康公司和醫(yī)療系統(tǒng)聯(lián)系在了一起。該公司基于醫(yī)療、行為和背景數(shù)據(jù)來設(shè)計(jì)并開展相關(guān)研究，以驗(yàn)證數(shù)字保健方法的效果，比如對社交媒體Buzzfeed推廣的Fitbit計(jì)步器進(jìn)行72小時(shí)的驗(yàn)證，或者長期觀察一款按時(shí)服藥App能否改善醫(yī)院的臨床治療結(jié)果。

????基爾帕特里克說：“基于這些研究結(jié)論，我們就可以改變客戶以及合作伙伴對其業(yè)務(wù)的看法。”

????一些數(shù)字健康公司已經(jīng)在有威望的行業(yè)評估刊物上公布了相關(guān)數(shù)據(jù)，以證明自身數(shù)字保健方法的效果，達(dá)菲的Omada Health就是其中較引人注目的一家。在用人單位支持下，該公司針對可能患慢性病的人群推出了一個(gè)為期16周的在線數(shù)字健康項(xiàng)目，作用是改變他們的行為。CEO達(dá)菲指出，這個(gè)項(xiàng)目于2011年設(shè)立，就是為了解決數(shù)字健康行業(yè)越來越缺乏證據(jù)的問題。他說：“我們從第一天起就在互聯(lián)網(wǎng)上公布數(shù)據(jù)?！監(jiān)mada Health積累了一年的數(shù)據(jù)后才公布了第一個(gè)同行評審研究的結(jié)果?，F(xiàn)在達(dá)菲表示，Omada Health是這個(gè)領(lǐng)域中唯一一家公布過某個(gè)數(shù)字健康項(xiàng)目兩年數(shù)據(jù)的公司。

????達(dá)菲指出，毫無疑問，進(jìn)行以證據(jù)為基礎(chǔ)的研究從邏輯上看很復(fù)雜。入門級研究的成本就可能達(dá)到數(shù)十萬美元，而更深入的研究會耗資數(shù)百萬。但他認(rèn)為這樣做是對的。畢竟，如果沒有證據(jù)支持，誰也不會讓病人接受新的藥物或手術(shù)。

????達(dá)菲說：“我覺得數(shù)字健康也不應(yīng)例外。在我看來，數(shù)字健康行業(yè)需要朝著這個(gè)方向邁進(jìn)，以便越來越多地贏得信任。”

????一些創(chuàng)業(yè)者已經(jīng)向達(dá)菲提出請求，希望為自己的產(chǎn)品和服務(wù)找到證據(jù)。達(dá)菲表示，此類請求的數(shù)量表明，數(shù)字健康公司開始意識到將自身技術(shù)商業(yè)化的最佳途徑就是證明它的效用。他說：“今后四、五年，能拿出確鑿證據(jù)的公司將變得不那么少見。”（財(cái)富中文網(wǎng)）

????譯者：Charlie

????校對：詹妮

????Countless entrepreneurs around the world have launched digital health companies in the last decade and more than 100,000 mobile apps are currently on the market—all with the goal of making us healthier. But how many of these companies have concrete evidence to support their health claims?

????Not many, says Sean Duffy, co-founder and CEO ofOmada Health, a digital health company that develops programs for people at risk for chronic disease. “It’s still rare,” he adds.

????In fact, there’s such a lack of clinical and economic evidence on the effectiveness of digital health products and services that a new startup was created just to focus on the problem. Evidation Health works to parse the marketing claims of digital health companies, which are rarely proven using scientific evidence, says CEO Deborah Kilpatrick.

????“I wouldn’t couch it in the context of, ‘these companies are making claims they can’t back up,’” she says. “They just haven’t [proven them]. Whether or not they can remains to be seen.”

????Kilpatrick blames little time, knowledge and money spent on evidence in the digital health world for the lack of proof. “In all fairness,” she says, “digital health as a sector is still fairly young.”

????Many digital health companies are just now reaching maturity—they’re angel funded or in Series A or B rounds—and the sector is still figuring out what it means to prove effectiveness, Kilpatrick says. The entrepreneurs building these companies frequently come from the consumer sector, rather than healthcare, she says, so while they understand the importance of evidence, they don’t know how to generate it.

????Clinical trials—the standard in proving the effectiveness of health interventions—can be prohibitively expensive. And these tests usually require a partner with ample resources and access to patients, such as a hospital. Healthcare systems are often reluctant to partner with small companies that don’t have evidence, and these companies can’t get the evidence without a partner. Another hitch: hospitals are accustomed to being paid to host clinical trials, but startups want hospitals to pay them to pilot their solutions.

????Market potential in the consumer tech world is based on customer adoption, Kilpatrick says. But in healthcare, often slow-moving hospital systems, insurance payers, and pharmaceutical companies drive adoption. “It’s a much more complex and larger process of adoption,” she says.

????Several factors play a role in a hospital’s adoption of digital health technology, says Dr. Richard Milani, chief clinical transformation officer at Ochsner Health System. Healthcare needs disruption, he says, but it must be done carefully.

????“You want to be comfortable that the technology you’re utilizing is reliable and accurate,” Milani says. “That’s a genuine concern. If you have some scientific data or peer-reviewed data to back it up, that certainly makes it a little easier.”

????Evidation Health, which is backed by GE Ventures and Stanford Health Care, brings together digital health companies and healthcare systems. Evidation designs and executes outcome studies based on medical, behavioral and contextual data. The studies range from a 72-hour investigation into Fitbit claims made by Buzzfeed to a long-term look into whether a medication adherence app can improve a hospital’s clinical outcomes.

????“This allows us to redefine for clients and partners the way they think about their business on the basis of these outcomes,” Kilpatrick says.

????Duffy’s Omada Health is one notable example of a digital health company that has published its outcomes data in respected peer-reviewed journals. Omada offers an employer-sponsored 16-week online digital health program to promote behavioral change in people at risk for chronic disease. It was founded in 2011 in response to the growing lack of evidence in the digital health sector, Duffy says. “We had the intent to publish from day one,” he says. Omada’s first peer-reviewed study wasn’t released until the company had a year’s worth of data. Now, Duffy claims Omada is the only company in its space to publish two-year data from a digital program.

????There’s no doubt, Duffy says, that producing evidence-based studies is logistically complex. The cost of an entry-level study is likely to reach into the hundreds of thousands, though more robust research can tip into the millions. But, he says, it’s the right thing to do. After all, we wouldn’t subject patients to a new pharmaceutical or surgery without the evidence to back it up.

????“I don’t know why digital should be the exception,” Duffy says. “That’s the direction I think digital health needs to take to gain increasing trust.”

????Based on the number of queries he gets from entrepreneurs who want to generate evidence to back up their products and services, Duffy says digital health companies are beginning to realize that the best way to commercialize their tech is to prove it works. “In the next four or five years,” he says, “it will become less rare.”