Entries in Clinical & Quality (37)


Patient Reported Outcomes

By Clive Riddle, May 15, 2015

The National Quality Forum defines Patient-Reported Outcomes (PROs) as "any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else." They elaborate that “in other words, PRO tools measure what patients are able to do and how they feel by asking questions. These tools enable assessment of patient–reported health status for physical, mental, and social well–being.”

The concept is obviously not new, but has certainly been overlooked at times. In an era with tremendous advances and emphasis in patient engagement, mobile health technologies, patient-centered care, we need to continue to see application of PROs receive the attention they deserve.

Dr. Bruce Feinberg, vice president and chief medical officer of Cardinal Health Specialty Solutions, tells us "As our healthcare system moves toward a value-based care model, the role of the patient is becoming increasingly important. We need to reframe the way we think about care to include not only the cost and clinical effectiveness of the treatment, but also the burden of disease and therapy on the patient's perceived sense of well-being. Patient-reported outcomes (PRO) are key to this equation, particularly for patients being treated for high-cost, complex diseases such as cancer or rheumatoid arthritis (RA)."

Dr. Feinberg’s organization is presenting a series of new clinical studies demonstrating the potential role of PRO research in improving the quality and reduce the costs of treatment provided to patients with complex diseases, at the International Society of Pharmacoeconomic and Outcomes Research (ISPOR) annual meeting.

Here's an overview of some of the key findings they will be presenting:

  • One study used PRO to demonstrate that rheumatologists significantly underestimated the negative impact of RA disease burden and treatment on their patients' sense of well-being. Understanding this disparity in perceptions can help physicians make effective treatment decisions that lessen the burden on patients – and can sometimes also reduce the costs of their care.
  • Another study showed that PRO can be critical to identifying and managing medication access and adherence challenges for high-cost specialty drugs.
  • Of a total of 239 oncology and rheumatology patients who were contacted at the time of their initial prescription to provide patient reported outcomes, 28% were identified as having problems that either restricted access or adherence to the drug.
  • Armed with this information, interventions and support services were provided to address those challenges. With the support of these interventions, a medication possession ration exceeding 95% was achieved – enabling nearly all patients to initiate or continue treatment.
  • A third study  proved the feasibility of collecting PRO at the point of care. In the clinical study involving 3,185 RA patients, PRO data was captured during 90% of physician visits. The participating physicians were then able to utilize the data to inform real-time treatment decisions at the point of care.

Top Ten Medical Innovations for 2015

By Clive Riddle, October 31st, 2014

The Cleveland Clinic annually announces their take on the Top Ten Medical Innovations that are likely to have major impact on improving patient care in the coming year. They have just released their ninth annual version of this list, selected by a panel of 110 Cleveland Clinic physicians and scientists. With no further adieu, here – verbatim – is their narrative on their compilation of the Top 10 Medical Innovations for 2015:

  1. Mobile Stroke Unit
    Time lost is brain lost. High-tech ambulances bring the emergency department straight to the patient with stroke symptoms. Using telemedicine, in-hospital stroke neurologists interpret symptoms via broadband video link, while an onboard paramedic, critical care nurse and CT technologist perform neurological evaluation and administer t-PA after stroke detection, providing faster, effective treatment for the affected patient.
  2. Dengue Fever Vaccine
    One mosquito bite is all it takes. More than 50 to 100 million people in more than 100 countries contract the dengue virus each year. The world's first vaccine has been developed and tested, and is expected to be submitted to regulatory groups in 2015, with commercialization expected later that year.
  3. Cost-effective, Fast, Painless Blood-Testing
    Have the days of needles and vials come to an end? The new art of blood collection uses a drop of blood drawn from the fingertip in a virtually painless procedure. Test results are available within hours of the original draw and are estimated to cost as little as 10% of the traditional Medicare reimbursement.
  4. PCSK9 Inhibitors for Cholesterol Reduction
    Effective statin medications have been used to reduce cholesterol in heart disease patients for over two decades, but some people are intolerant and cannot benefit from them. Several PCSK9 inhibitors, or injectable cholesterol lowering drugs, are in development for those who don't benefit from statins. The FDA is expected to approve the first PCSK9 in 2015 for its ability to significantly lower LDL cholesterol to levels never seen before.
  5. Antibody-Drug Conjugates
    Chemotherapy, the only form of treatment available for treating some cancers, destroys cancer cells and harms healthy cells at the same time. A promising new approach for advanced cancer selectively delivers cytotoxic agents to tumor cells while avoiding normal, healthy tissue.
  6. Checkpoint Inhibitors
    Cancer kills approximately 8 million people annually and is difficult to treat, let alone cure. Immune checkpoint inhibitors have allowed physicians to make significantly more progress against advanced cancer than they've achieved in decades. Combined with traditional chemotherapy and radiation treatment, the novel drugs boost the immune system and offer significant, long-term cancer remissions for patients with metastatic melanoma, and there is increasing evidence that they can work on other types of malignancies.
  7. Leadless Cardiac Pacemaker
    Since 1958, the technology involved in cardiac pacemakers hasn't changed much. A silver-dollar-sized pulse generator and a thin wire, or lead, inserted through the vein kept the heart beating at a steady pace. Leads, though, can break and crack, and become infection sites in 2 percent of cases. Vitamin-sized wireless cardiac pacemakers can be implanted directly in the heart without surgery and eliminate malfunction complications and restriction on daily physical activities.
  8. New Drugs for Idiopathic Pulmonary Fibrosis
    Nearly 80,000 American adults with idiopathic pulmonary fibrosis may breathe easier in 2015 with the recent FDA-approval of two new experimental drugs. Pirfenidone and nintedanib slow the disease progress of the lethal lung disease, which causes scarring of the air sacs. Prior to these developments, there was no known treatment for IPF, in which life expectancy after diagnosis is just three to five years.
  9. Single-Dose Intra-Operative Radiation Therapy for Breast Cancer
    Finding and treating breast cancer in its earliest stages can oftentimes lead to a cure. For most women with early-stage breast cancer, a lumpectomy is performed, followed by weeks of radiation therapy to reduce the likelihood of recurrence. Intra-operative radiation therapy, or IORT, focuses the radiation on the tumor during surgery as a single-dose, and has proven effective as whole breast radiation.
  10. New Drug for Heart Failure
    Angiotensin-receptor neprilysin inhibitor, or ARNI, has been granted "fast-track status" by the FDA because of its impressive survival advantage over the ACE inhibitor enalapril, the current "gold standard" for treating patients with heart failure. The unique drug compound represents a paradigm shift in heart failure therapy.

Wondering what Cleveland Clinic proclaimed a year ago would be the top innovations for this year? Here was their top ten list from last year:

  1. Retinal Prosthesis System – Early Stage Bionic Eye
  2. Genome-Guided Solid Tumor Diagnostics
  3. Responsive Neurostimulator For Intractable Epilepsy
  4. Direct-Acting Antiviral Oral Hepatitis C Drugs
  5. Perioperative Decision Support System
  6. Fecal Microbiota Transplantation

  7. Relaxin For Acute Heart Failure
  8. Computer-Assisted Personalized Sedation System
  9. TMAO: A Novel Biomarker For Heart Attack, Stroke Risk
  10. B-Cell Receptor Pathway To Treat Blood Cancers

Ten Things to Know About Ebola Today:

Clive Riddle, August 15, 2014

While Ebola is only rampant in Africa, cases are now out-migrating, and Ebola is finally starting to get the increased  attention of the world it needs.  For those of us half a world away, we typically want to condense this information down to how it might ultimately indirectly or directly affect us. Unfortunately, some of that attention is overly shaped by fear, misinformation or even political agendas.

The CDC is a great resource site on Ebola Hemorrhagic Fever ,  including Ebola Virus Disease Information for Clinicians in U.S. Healthcare Settings.  NPR has a post today interviewing Jeanine Thomas, on why the Ebola decision has relevance for the U.S. health care system.  Much of the dilemma in West Africa is due to their lack of healthcare resources compared to more industrialized nations, as discussed in a Science Daily article posted yesterday, Ebola outbreak highlights global disparities in health-care resources, which pulls from NIH and New England Journal of Medicine content.

Perhaps a best first step for non-clinicians in the business of healthcare, is to become more conversant in the current state of affairs for Ebloa. As Lee Norman, MD, chief medical officer for The University of Kansas Hospital, reminds us, “the current Ebola Virus Disease is the deadliest on record but it is important to understand key elements of this virus. He and the University of Kansas Hospital have just released an excellent summary in the regard: 10 things to know about Ebola, we’ll repeat in its entirety:

  1. Cases Are Out-Migrating From Africa: This is happening due to the fact that infected or ill people are traveling out of those countries in Africa with Ebola outbreaks. Cases found outside of Africa may likely go up as the number of people leaving outbreak areas increases when aid-workers and others return to their home countries.
  2. No Cases of Human-to-Human Transmission Outside of Africa: There has been no human-to-human or other transmission to humans outside of Africa.
  3. Ebola Is Not Transmitted By Air, Only Via Bodily Secretions: Ebola is not respiratory, so it is not transmitted through coughing or breathing. These infections are occurring because of people who are exposed to bodily fluids of infected individuals.
  4. Ebola Is Not The Most Infectious Disease: As infectious diseases go, Ebola virus isn't inherently the most infectious nor is it the least infective from person-to-person. Measles and chickenpox, for example, are easier to spread. So are influenza and MERS.
  5. High Mortality Rates Due to Geography: The mortality rate is quite high in Africa Ebola cases, partly because of the chaos, instability, and unrest of the governments there, and very directly related to the fact that their access to standard treatment supplies (IV solution, tubing, syringes, and protective equipment) is not universally available. Ebola cases identified and treated in westernized nations, and those with modern infection control practices, will have a much lower rate than those seen in most African regions.
  6. Likelihood of Breakouts In Areas Outside of Africa: Meticulous infection control practices in modern hospitals will make it more unlikely that human-to-human transmission will occur in these settings. While expensive and advanced bio-containment units provide the highest level of infection control, it is unlikely that these units will be widespread throughout the world.
  7. No Approved Immunizations and Treatments: There are no approved immunizations to prevent Ebola virus infection. There are no approved treatments for Ebola virus infection. There are experimental antibody treatments, as well as an antiviral medication not approved for Ebola. But whether either or both are safe or effective for widespread use is not known. "Compassionate use" or "experimental use" of the above treatments is tempting, because no targeted, specific "conventional treatment" exists. But widely adopting experimental, unproven medications as "the new conventional therapy" has its own difficulties: Is it safe? Is it effective? Is it costly? Are there unanticipated "down-sides" to using them? A WHO ethics panel has given the go-ahead for this, something it has never done before.
  8. How Animals Play a Role: The non-human vectors that can harbor Ebola virus (fruit bats, non-human primates) are widespread in areas far removed from Africa. As such, it bears watching whether those vectors begin to harbor the virus. The WHO has an excellent map showing the parts of the world with these vectors.
  9. Alert Levels: The WHO and CDC both recently increased their respective alert levels. State and local health departments throughout the U.S. and world will certainly seek guidance as to the adoption of best "local practices" to guide hospital and care providers. The guidance by the CDC as to how to manage exposed individuals and those who might be incubating the infection are quite specific and helpful. They will certainly change as time goes on.
  10. What We Don't Know About Ebola: There are things unknown about Ebola. For example:
  1. Can a person have had a low-level infection and not know they ever had it? Probably, based on serum testing.
  2. Does a person who has had it and survived develop lifelong immunity? That is unknown at this point. The various strains of Ebola are enough different antigenically that there may not be cross-immunity.
  3. Is there such a thing as a "chronic carrier state" in humans where a person can shed the virus and be infectious for a long period of time, even when they themselves have no illness or symptoms? That is also unknown at this point.

Stopping on Green - Part 2

By Laurie Gelb, July 28, 2014

(Read the first installmant of this part post at Stopping on Green

 They Don’t Need No Satisfaction

If/as we rethink the adherence doctrine, with its emphasis on following bottom-up, and begin to consider supporting patients as largely self-informed deciders rather than passive consumers, to what corollaries does that lead?

Imperative 1: Consign “patient satisfaction” to the worm bin, and focus on beliefs and behaviors that drive optimal outcomes.  These are not the same thing. The latter arise from knowledge, experience and culture.  Patients aren’t satisfied, and can’t be, with a product that they hate, fear and continually shy from, unless they seek it out obsessively. They can be content with a single or series of encounters that turn out well, or “the best they could,” but we don’t want them to repeat the experience unless/until they have to, and indeed most of them [the worried well notwithstanding] don’t.  In what other category do we worry about who likes Dr. Smith how much while telling all and sundry that only 10% of the solution rests with Dr. Smith? And speaking of that 90%…

Imperative 2: Disease management that constrains high utilizers’ cost curves while optimizing the outcomes for which we all pay.  As we tell patients continually, but fail to support, we are actually not in charge of managing _their_ disease. To manage disease, we have to support patient, clinician and caregiver choices that avoid duplication, optimize coordination and keep health, not health care, as the laser focus. 

Imperative 3: An an e-health platform that supports all of the above.

E-health is only as good as the health part. It can’t be acceptable to cede EMR design to bureaucrats, process refinement to the business office and online functionality to Webmasters and programmers. 

Baby, I Don't Have a Car

Are we so focused on “consumer-driven care” that we have forgotten to provide consumers with a vehicle to drive toward optimal outcomes? 

We can’t decide to educate simply if/how/when to deviate from our bibles. It doesn’t pay enough for a layperson to learn our bibles. We have to educate in a different way — not simply about vocabulary and labels (the much-touted health literacy, which means about as much as knowing how to read an electrical schematic out loud). 

We can, as any educational program, provide healthcare intelligence. A consumer knows how to change a light bulb and if/how she can rewire a socket. In short, she knows what she doesn’t know. When we preach “follow,” many patients are honestly unsure as to the decisions they have the capacity to make. Then, when they call the overloaded provider’s office to ask about their current concern, we fail to address the underlying uncertainty about the parameters that prompted the question in the first place. Definitions of terms are not a substitute, since knowing what wiring is doesn’t mean I’m off to the junction box.  

The Long and Winding Road

I know that on some freeways, I can exceed the speed limit, but that still doesn’t mean I can drive 100 mph [an action whose commitment time is obviously greater, given braking distances, than if I were driving 70]. I also know that speed can mean death [stakes]. We know that we must never pour a drop of water into a gas tank, to take one example. Or that we should never pour gasoline onto a flame. We are not going to deviate “just a little” to see what happens. How did we internalize, abstract the rationale for these absolutes? We learned something from someone and/or tried it once, depending on our respective backgrounds.

Even when disease management prides itself on counseling small, incremental changes (bring an apple to work!), we are prescribing without insight on either side. If I hate apples, I’m left wondering if it’s comparable to bring a red plum, which I do like. Think about how long that simple question would take to answer via the Internet, and you have a glimpse of the muddy information overload around fruit. And everything else that might be healthy. 

Few of us eat eight servings of fruit and veggies daily (or know how many we ate). We can’t. When as content providers we offer these lofty outcome measures as “information,” consumers roll their eyes, laugh, sigh, blink, snort, tune out and move on. We want and expect them to deviate if/as necessary. In wellness, we encourage them to “do the exercise you like” and eat the greens they like, etc. We don’t say, eat a carrot salad every day because we know they wouldn’t, however good an idea it might be. Yet our most common copy point in command voice is, “Eat [insert official content here].” That implies a literal meaning, for something that we don’t mean. This language is worse than gibberish; it spawns opposition because it rings so far from the truth of daily living. 

Moreover, to apply information, you have to know something about evaluating information quality, relevance and how literally you need to take it.  How are we imparting a health care “street sense?” 

Teach Your Patients Well

If we put on a can of peas the bland, cover-the-bases “content” that populates the major health information sites, human knowledge of peas would come from experience and the “word on the street,” just as it does for other areas in which the “official voice” is seldom heard because it is too opaque. How much of what you know about street drugs comes from officialdom? Amazon can recommend, sales associates can counsel, but for health care, with far greater stakes, there’s canned risk assessments (scripted encounters, waiting room brochures, package inserts, click here for a percentage you’ll need the footnotes to understand). For the obese, the dyslipidemic, the diabetic, the hypertensive, the smokers, we’ve made a better path the ultimate cliché. 

For decades, we’ve said, “We need to teach people the principles of weight management,” while forgetting the public health 101 concept of self-efficacy. If they don’t believe they can’t do it, they won’t even try. Weight management and all the rest of the “good ideas” require a series of choices that many people don’t believe they have the wherewithal to undertake, particularly in the face of an increasingly contradictory evidence base that our nagging letters usually fail to acknowledge at all. We’re not having conversations, as occur whenever you chat with your mechanic; we’re lecturing, pretentiously, and everyone’s falling asleep, only to wake up when the EOB appears.

And then we have the “act as if” faction in our ranks. “Big change is the only way it happens!” Yes, big change can happen if/when someone is scared, cornered, bored, self-impatient, angry, sorrowful. But we’re being paid on outcomes. Can we bank on emotion to inspire often short-lived change? And change from what? Our baseline measurement system is hopelessly flawed. Surveys reveal “the right answer.” Focus groups are pay for-a-play. Claims data reflect reimbursement, less often reality. Medical charts reflect adversarial legal incentives and a shortage of time. Even “real dialogues” during outpatient visits vamp to the camera, and social media monitoring finds the outliers with lightning speed. The best evidence of the real you have at your disposal any time is looking at you in the mirror.

Tell Me Why

Our risk assessment tools don’t allow the patient to contribute the facts that s/he knows best. Clinicians use heuristics to document and chart. Most charted histories omit at least one potentially relevant condition, event or genetic predisposition; it was not on a form, and/or it was not discussed. Many patients also reveal “medical history fatigue” which constrains the completeness of any particular history, and patients who have seen their chart notes are also aware that not all the information they provide is captured, apart from the form itself.  

 Since our brains are small, our days short and we’re only human, just as we have to use heuristics (decision shortcuts) to make everyday decisions about which route to take to work or what to order for lunch, we use heuristics to prioritize, consider, make, avoid, deny, delay and simply tune out myriad health issues and choices.  We’ve failed miserably to convey stakes and commitment times in health care, a lack of knowledge that can only constrain optimal decision-making. If an alien from another planet watched TV or went online for a few minutes, who could blame him for thinking that allergies or erectile dysfunction must be the world’s worst plague? 

It's All in the Game

In short, instead of focusing on an illusory “healthy mindset” whose stock doctrines are breathtakingly obvious (don’t touch the hot stove, stop smoking and cut back on Twinkies), we can more productively allocate all the money spent on bland DM pap to upgrading to the decision support available for silk blouses and video games. 

This week’s stiff-upper-lip letter from a major network, syndicated by a major vendor: …”We understand that there are many reasons why you may not want to take your medication…if you have any questions or concerns, we encourage you to contact your doctor or local pharmacy.”  Talk about “information” that will never be [read or] used! Each two-page letter contains two sentences about the particular drug’s rationale and consequences for not taking it; the rest is unadulterated condescension. How recently was any of your communication…interactive? Inquisitive? Conversational? Brief? 

Direct education in decision-making requires not just doling out information, but encouraging its acquisition through other channels, preaching that it is best leveraged in combination and in understanding, not rote. And then, it falls to MCOs, agencies, clinicians, jurisdictions…anyone with skin in the game, to kick our cheerleaders off the field and start playing full contact football. Our opponents include disease, ignorance, fear, denial, poverty, hunger, addiction and crime. And they've got a large lead. 


All Things to All People Isn't Working

By Kim Bellard, July 18, 2014

When it comes to hospitals, we may need to paraphrase Lincoln: they can treat all of the people some of the time, and some of the people all the time, but they can't -- or, rather, they shouldn't -- try to treat all of the people all of the time.

US News & World Report just released their annual "Best Hospitals" rankings.  They evaluated nearly 5,000 hospitals against a detailed methodology

What struck me was that, out of those nearly 5,000 hospitals, only 144 scored a national ranking in even one specialty.  None -- I repeat that, none -- ranked in all 16 specialties.  Only Boston, Los Angeles, and New York had more than one Honor Roll hospital.  Several states have no hospital with a national ranking in any specialty.

There's a lesson there.

A few days ago Clayton Christensen, the Harvard-based guru of "disruptive innovation," told Forbes that the U.S. health industry is "sick and getting sicker."  He offered several suggestions for what he thinks need to change, but I want to pick one in particular, his emphasis on cutting administrative waste.  

It is not unusual to cite administrative waste as a problem in our health care system, but Christensen comes at it from a different angle.  As he said:

An increasing proportion of [health care] cost is spent on administrative and overhead activities that are not productive in any way.  They exist because we assume every hospital should be able to do everything for everybody. But that’s not possible if we want quality and efficiency. Overhead creep is the result.

Toby Cosgrove, the CEO of The Cleveland Clinic, gets it as well (or at least, says the right things).  As he recently said at the Aspen Ideas Festival: "What we need to understand is that not all hospitals can be all things to all people."

Cosgrove noted The Cleveland Clinic's expertise in cardiothoracic surgery, done on a scale that he believes results in care that is cost-effective and of high quality.  They draw patients for these services not just from their metro area, their region, or even just the U.S., but also internationally.  He wants to see a future where we get patients to the right physicians, rather than trying to have expertise available everywhere.

Given the solid data on the importance of volume/experience, then, why are each of my local hospitals trying to make themselves the leader in, say, open heart surgery?  Or in cancer, neurology, or sports medicine for that matter? 

Somehow it is hard for me to believe they've got my interests -- the patient's interests -- as their top priority.  

Becker's Hospital Review recently hosted an Executive Roundtable on affiliation, and I was struck by a comment one of the hospital CEOs made:

There are too many tertiary facilities' values are not aligned with rural hospitals' values: Their goal is to pull patients out of smaller communities, which is not what smaller communities are looking for in an affiliation. Keeping patients close to home is what's important.

Wouldn't you like to think that doing what is best for the patient is what's important? 

The point is, most of us don't live in places where we should be expecting that we're going to get the best care for every condition locally.  Nor should we expect that even the "best" hospital/health system for some conditions are best for other conditions as well.  Who is treating you where for what matters.

This post is an abridged version of the posting in Kim Bellard’s blogsite. Click here to read the full posting