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AbstractPatient Reported Outcomes Measures (PROMs) have been used since the 1960’s, with some of the earliest in the field of mental illness. Today, there is a large and increasing number of PROMs across virtually all medical specialties.PROMs continue to be used principally for research purposes. However, there is growing recognition of their potential to assist in clinical decision making, value-based medicine and sustained patient engagement. PROMs can thus be a useful vehicle for addressing some of the larger challenges in modern healthcare.However, the design and use of PROMs present serious challenges for the busy clinician. These include selecting or designing the PROMs most relevant to a specific practice, execution, cost, personal health information protection, patient enrollment and continuing engagement, data verification and audit trail, adequate data to generate statistically significant correlations.Fortunately, modern tools now allow clinical groups of any size to generate clinical and financial value from PROMs.PROMs: The Theory And The RealityCapturing longitudinal outcomes data is essential to evidence-based medicine. Thus, standardizing PROMs constructs and scoring systems for all categories of clinical interventions and patient cohorts is a worthy goal. Many medical societies, for example, develop PROMs in the context of their registries. Other organizations publish free and licensed PROM’s. Other groups analyze the strengths and weaknesses of various PROMs.On the one hand, there typically exist multiple PROMs for any pathology. On the other hand, the busy clinician will find it daunting to select PROMs which drive clinical and other value in his particular context. Moreover, PROMs for the same condition can be in part contradictory, duplicative, incomplete and/or confusing. Well intentioned attempts at standardization of PROMs have been unavailing.PROMs As Tools In The Clinical SettingPROMs can play an important role in two major trends in modern healthcare — value-based medicine and clinical decision-making.Value-Based MedicineAs stated in the New England Journal of Medicine:Value-based healthcare is a healthcare delivery model in which providers, including hospitals and physicians, are paid based on patient health outcomes. Under value-based care agreements, providers are rewarded for helping patients improve their health, reduce the effects and incidence of chronic disease, and live healthier lives in an evidence-based way.This approach is found in accountable care organizations, narrow networks, and many other clinical intervention revenue models. Capturing and analyzing outcomes in a systematic, longitudinal manner are essential elements of value-based medicine.However, efforts to derive useful correlations for value-based medicine from EMRs, claims databases, patient registries, and other traditional data sources have been disappointing. These sources often reflect only partial data, poor clinical context, challenges in verifiability, and other weaknesses. Of particular note, there is usually a paucity of outcomes data, and wide variation and discrepancies in what little exists.Meeting these challenges with respect to PROMs begins at the clinic. The treating clinician must select/design the proper PROM construct for each patient cohort. For example, what exactly is the PROM intended to measure – pain, function, quality of life etc. – in the context of a particular class of clinical intervention? Only then, will the outcomes data truly support value-based medicine.Clinical Decision MakingMedical science is advancing ever more quickly. Clinicians must learn to deal with concepts not even mentioned during medical school, as well as new equipment, medications, and diagnostic tests. Modern communications channels offer practitioners and their patients good and bad information on any topic – both good and bad.Despite these oceans of information, or perhaps because of them, the informed judgment of the experienced clinician remains central to accurate diagnoses and safe, efficacious treatment protocols.PROMs As The Foundation of Patient-EngagementAn attractive website, efficient front office, well-lit reception area, testimonials and five-star reviews are only the beginning of patient engagement in the 21st century.Yes, patients are consumers; but they are first and foremost patients. They have a patient story, one or more specific conditions, outcomes objectives, perhaps disappointments with past treatments. Patients have often already researched their conditions and options. They want to be heard, and to be a part of their recovery. Moreover, listening to patients from the initial consult and then throughout their treatment journey can be critical to successful outcomes.PROMs can represent an excellent tool for intermediating the respective “languages” of the patient and the clinician. Properly designed and executed, they make clear to the patient that her doctor is genuinely interested in the success of the long-term outcomes they both are seeking.Removing The Burden; Generating The ValueAs indicated, PROMs have significant potential clinical, patient engagement and financial value. For them to be a realistic part of the active clinician’s armamentarium, however, they must have several key characteristics:Impose minimal burden on the clinician, her staff, and patients.Conform in their constructs to the indications, treatment protocols and other aspects of the clinician’s everyday practice.Comply with patient data privacy and security laws.Real-time mapping of outcomes against a variety of clinician-selected treatment factors.Generate statistically and clinically significant correlations.Allow easy collaboration within peers within and across institutional and national boundaries.Circles enable all of the foregoing. Start or join one today. Or contact us to find out more.

For most clinicians, medicine is a business as well as a calling. This is true for employed, as well as those with independent practices. Costs may include rent, staff, marketing, IT systems, capital equipment, consumables and/or continuing education. Income may include fees-for-service, RVU’s, salaries, grants, honoraria, investigator fees, and/or “value-based” payments.Unfortunately, neither medical school nor clinical practice prepares doctors for the business of medicine. Although U.S. healthcare expenditures are $4.3 trillion – over 18% of the country’s GDP – practicing physicians receive an ever-shrinking portion.Circles not only provide powerful clinical utility; they represent a substantial and transparent return on investment. That investment is only $500 for the first Circle, $35 per month and $5 per Case. Moreover, the Circles license can be terminated any time upon thirty days’ written notice.The return on that investment, with minimal clinical burden, includes:At least 12 months of physician-defined outcomes capture for each $5 Case: Make better clinical decisions. Identify potential adverse events early.At least 12 months of sustained and meaningful patient engagement for each $5 Case: Improve patient retention. Acquire new patients. Earn better reviews.Valuable aggregated datasets: Establish evidence-based approaches for new indications, protocols. Support reimbursement. Comply with legal/regulatory requirements. Support grant proposals.Better relationships with product manufacturers: Earn honoraria, investigator fees, study-based product discounts, conference support.Professional education: Collaborate with peers and experts within or across institutional and national boundaries. Test personal clinical hypotheses.Publication and Influence. Generate fresh and evidence-based content for articles, conference presentations, practice website, posts, journals, social media.Circles can convert the real-world data inherent in your everyday Cases into a sustainable profit center. Join A Circle today, or contact us to find out more.

All the power of modern social media channels, but with the security, focus and collegiality of medical conference break-out sessions. Present, discuss, teach and learn. Easily find clinical, scientific and professional topics of interest. Moderated "Spaces" open only to credentialed clinicians. Product-agnostic. Free.Private chats, livestream events, multimedia content. Content based on real-world evidence generated by your peers from their everyday practices.‍Each Space dedicated to a specific indication and/or clinical protocol. Create your own Space, or join others. Set access permissions for each Space.Access Industry Spaces for product information, training, investigator fees, honoraria, product discounts, other opportunities.‍RegenMed support: Multimedia content. Multi-channel distribution. Practice website pages. Engagement with industry. Technical. For more information, contact us at circleacademies@rgnmed.com.To join the Real-World Evidence Circle Academy,click here.

Collaborative clinical solutions for generating real-world data, evidence and value.The Clinical Value of Real-World EvidenceYour daily clinical interactions are a trove of real-world data which current systems fail to capture and exploit. Meanwhile, real-world evidence, derived from real-world data, is increasingly sought by regulators, manufacturers, payers, patients and your peers. Therefore, capturing and converting relevant real-world data into your real-world evidence represents an integral path towards achieving your personal, professional and academic goals, including:Patient Marketing and Engagement Presentations and PublicationsSponsored Studies and Trials Legal and Regulatory CompliancePractice Growth Clinical Decision-MakingReal-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.July 2021 FDA.gov‍The Solution in CirclesCircles, built by and for practitioners, combine clinical-grade electronic data capture technology with secure international and inter-institutional collaboration. They are simple, burden-free and engaging solutions for the generation and dissemination of clinically relevant real-world evidence. Practitioners from around the world entrust their studies, trials, registries, collaboratives, and more to Circles. Contact us to learn more about Circles.

Practitioners are increasingly being asked, instructed and/or incentivized to join data registries. These collaborative solutions allow practitioners to capture, aggregate and correlate unique real-world data not native to their EMR/EHR systems, including patient-reported outcomes. There is no shortage of solutions, many with dizzying levels of features, integrations, pricing models and clinical specializations.The following article summarizes our decade’s worth of experience in developing, (failing) and ultimately succeeding in building hundreds of growing registries around the world. In those ten years, we also have had a chance to learn a lot about the market, competitors, shifting regulations, and the nuances of evolving patient privacy policies, including the new Global Data Privacy Regulations.We have distilled those experiences into 5 simple questions, whose diverse answers will surprise you, and ultimately help you make the best registry choice for you and your patients.1. Who owns the Data?The data is valuable, especially so when aggregated by many investigators against a shared protocol. If you’re putting in the work, do you at least own the data? The answer can be complex.First, not all data are equal. Information which clearly identifies the patient (Personal Information in Europe and Protected Health Information in the U.S.) is often considered exclusively “owned” by the patients themselves. If a vendor claims that you own all data in a registry, it can be inaccurate and/or a direct breach of local privacy laws. Therefore, your primary goal should ownership of anonymous or de-identified data sets.Second, there are numerous stakeholders within a registry: investigators, patients, external funders and the registry vendor themselves. You may be an owner of your data, or even more likely, a co-owner among many other stakeholders. The GDPR recommends entering in an “aggregated data ownership agreement” to clearly lay out commercial and other rights among multiple stakeholders. We recommend the same.Lastly, ownership, monetary rights and distribution rights are three independent elements, each of which should be spelled out in an appropriate agreement. What good is ownership if you can’t use it and/or don’t have a share in any monetary value? In summary, don’t just ask “Who owns the data”, make sure you sure you understand the nuances around which data, co-ownership models, and rights with respect to ownership, monetization AND distribution.2. What does it cost?If you are participating in a registry, you will be dedicating time, energy and valuable staff resources to begin enrolling patients and entering data. Some registry vendors will additionally ask that you pay a license or other fee to use their solution. You’ll have to therefore weigh the net costs: pricing, your time + staff time, against the perceived value of the registry itself. You will want to also consider the revenue model of each vendor. All companies live and breath by profit, and their revenue model is a good indicator of where they will focus their time and energy. For example, if they have high upfront installation fees, and low recurring subscriptions, you might expect excellent service initially, with low, cost-saving service and support longer-term. Look for revenue models which are aligned with the ways you obtain value. The more aligned, the more incentivized the vendor is to help you extract the most out of your registry use and data.Finally, some registries are made free to use by practitioners, with fees covered by grants and other third-party sources. We think this is great, but make sure you re-read question 1 above. Third-party funders almost always have exclusive rights to data ownership, monetization and/or distribution.3. What can I get out of it?Boilerplate answers will include data, engagement, collaboration, or even, “your colleagues are doing it.”. If those sound fuzzy, unappealing and a far cry from immediate clinical, financial and professional value, you’re right. Proper use of registries can provide substantial benefits, but if your vendor can’t articulate those, then either you aren’t the beneficiary, or its up to you to put together all the pieces. Here are three tangible benefits any registry should be able to offer:Value and Reimbursement: Registry participation offers clear commercial benefits to its practitioners. Through federally funded programs such as Merit-based Incentive Payment System “MIPS”, or grants through Industry or other third-parties, there are plenty of opportunities to earn compensation for your registry participation and time. Choose a vendors who knows these opportunities, and can offer a clear pathway for how they can help you achieve those benefits. Professional Advancement: You should see a clear path for how the registry gathers data, data converts into evidence, evidence converts into insights, and how those insights directly improve your clinical, scientific and patient marketing objectives. If you are only there to provide and access data, you are two-to-three steps away from actionable insights.Expanded Academic Influence: Registries aren’t only an opportunity to collect data, but to also to collaborate and expand your academic influence amongst peers around the world. If you are the 1,000th member of a large registry, you are helping the registry founders expand their own Academic influence. Consider instead starting your own registry, with your own select group of collaborators, and earn your own expanded influence.4. Is your solution flexible?Registry flexibility is key for sustained or expanded adoption. Conversely, inflexibility can add time or burden, decrease the value and relevance of your participation, and in many cases, be prohibitive to further use.Every vendor will claim flexibility, but with so many potential areas to customize, are unlikely to cover all, including: Assessments eCRFs and Questions Follow Up TimepointsBranding Patient Communications/Experience Multiple Languages Data Sharing Settings Report Generation and ExportsUser Roles and Permissions eConsent Language PHI/PI storage User Authentication And much, much more Make sure you know in advance the level of flexibility you need, how it applies to your goals (see question 3) and request the following three critical follow ups: can you do it, how long will it take, and will it cost extra? 5. Ask for a reference.This is standard for hiring a new employee, but is conspicuously uncommon for choosing a registry solution. If you wish to truly peer under the hood of any prospective technology, ask first to speak with a few of their clinical users, or even better, with those clinician’s staff members responsible for its use. They will be refreshingly honest about the burdens, experiences and/or benefits they and/or their patients experience on a regular basis. While on the phone, feel free to ask some of the questions above for fresh perspective.