Engaging patients in screening for colon cancer

Colon cancer runs in families. If you have a relative with colon cancer, your chances of getting the disease are markedly higher than if you don't. The good news is that if you get a screening test periodically, the disease can be found early, treated relatively easily, and you can go about your business. The bad news is that we don't do enough screening, especially of first-degree relatives and especially in rural areas where the long drive to colonoscopy is a barrier.
Anita Kinney, a nurse and epidemiologist in Utah, led a teem of researchers from five states in testing whether telephone outreach could get more high-risk patients screened. They found patients at elevated risk of cancer by recruiting the relatives of diagnosed patients. They either got a mailed brochure or a 40 minute telephone call with a genetic counselor plus a follow-up letter (with a copy to their primary provider). This was a carefully designed and executed randomized controlled trial with 481 subjects, so the improvement in colonoscopy from 16% to 25% is not only statistically significant (P<0.001), but unlikely due to bias or confounding. Interestingly, the effect of the telephone intervention was about the same in rural, urban, high income, and low income groups.
Although this is an impressive and clinically important effect, this intervention is a bit costly. The authors don't provide details, but these counselors are highly-trained and sophisticated providers and it takes a lot of their time to handle each case. I have to agree with the authors that this intervention should probably be part of a stepped strategy with the genetic counseling reserved for those who don't get screened after less expensive methods are tried first, especially since they had such a nice response from their brochure.
Now the challenge will be how to integrate this proven intervention into an ongoing delivery model, and that means, an ongoing business model. Who will pay for the outreach and the colonoscopy, especially if the index patient has different coverage than their relatives?

Kinney AY, Boonyasiriwat W, Walters ST, Pappas LM, Stroup AM, Schwartz MD, Edwards SL, Rogers A, Kohlmann WK, Boucher KM, Vernon SW, Simmons RG, Lowery JT, Flores K, Wiggins CL, Hill DA, Burt RW, Williams MS, Higginbotham JC. Telehealth Personalized Cancer Risk Communication to Motivate Colonoscopy in Relatives of Patients WithColorectal Cancer: The Family CARE Randomized Controlled Trial. J Clin Oncol. 2014 Mar 1;32(7):654-62. doi: 10.1200/JCO.2013.51.6765. Epub 2014 Jan 21.

The Power of Small Data

Big data is the uncharted territory of our time. Vast, multiple exabyte-sized data sets are like new continents that will, upon exploration, yield insights into all manner of human affairs. This is all well and good. But in the meantime, how about applying the latest tools and techniques of Big Data to much smaller data sets, say an insurer's chronic disease patients?

Today, with high speed data exchange and processing, it is possible to comb through millions of lab tests to find the results of eligible patients, monitor their timing and values, and provide nearly instantaneous feedback to patients and providers. This is the power of Small Data.

Small data connects people with timely, meaningful insights. It is organized and visually presented to be accessible, understandable, and actionable for everyday tasks.

Small data is the right data. You shouldn't need to be a data scientist to understand or apply it for everyday tasks.

Paraphrasing Joseph C. Kvedar, MD, the Founder and Director of the Center for Connected Health, Big Data will guide policy makers, but it's Small Data that will help patients get better.

Living with and managing a chronic disease, such as chronic kidney disease, is complicated. Small Data can deliver the right information to patients and providers at the right time so that they can do the right thing.

Using hand-held technologies to engage patients

Two recent articles take a look at how some small devices - smartphones and tablets - can be used to foster patient engagement.

The smartphone project tackled a tough problem  - supporting patients with chronic disease (in this case, HIV) and heavy alcohol use to reduce their drinking. Expanding on their previous approaches using Interactive Voice Response (IVR) telephone calls, Deborah S Hasin, Efrat Aharonovich and Eliana Greenstein from Columbia University enrolled 43 alcohol dependent HIV-infected patients and followed them for 60 days. The average number of drinks fell from 9.3 per day to 3.9. An impressive 25.6% were alcohol-free at the end of the two months. You can get all the details from their report in Addiction Science & Clinical Practice.

The second article provides the early experience with a tablet system that was given to 30 hospitalized patients at the University of California, San Francisco. The iPad2 tablets had an educational program about patient safety and a link to the hospital's patient web portal. The 30 patients were able to use the devices and liked having them. This preliminary report didn't address any changes in outcomes that wiring up inpatients might bring, so it is a little soon to endorse this approach, but they overcame the first hurdles (getting the machines in the hands of the patients and getting the patients to use them). The authors (S. Ryan Greysen, Raman R. Khanna, Ronald Jacolbia, Herman M. Lee, and Andrew D. Auerbach) do promise that they will investigate post-discharge outcomes in future work. You can find this in The Journal of Hospital Medicine.

These innovations have potential. I'm looking forward to some solid assessments (randomized clinical trials, anyone?) in the next few years to help us separate the effective approaches from the marketing chatter.

Telephone coaching doesn't work for diabetes

A noble effort by the good folks at the General Practice and Primary Health Care Academic Centre at the University of Melbourne to demonstrate the effectiveness of telephone coaching by trained nurses in type 2 diabetes ended in disappointment.

As reported in the British Medical Journal, they randomized 59 primary care practices with 473 adults with A1C above 7.5%. The nurses in the  intervention practices were trained to make structured calls to their patients, engaging them in dealing with their chronic problems, managing stress, improving their lifestyle, self-monitoring their disease, and doing some other good things. The program included seven telephone coaching sessions over 10 months, a face to face coaching session at 12 months, and a final telephone session at 15 months. The nurses were paid to do the calls, overcoming an important barrier in many settings. In other words, this was a well-designed, fairly high-intensity intervention. And, the evaluation is very rigorous and well-designed with little room for random error or bias. These investigators are pros and it shows.

Unfortunately, it didn't work. After 18 months, the A1C in the intervention group was the same as the control group (P=.84). On the plus side, fewer intervention patients were overweight or obese (P=.03). However, some outcomes actually got worse: HDL-cholesterol (P=.05) and systolic blood pressure (P=.07). Given the very large number of secondary outcomes reported, and the lack of any big trends across the outcomes as a group, these apparent effects are probably random error due to multiple comparisons. All in all, there is no evidence that this intervention had important effects on the patients or the health care system.

This isn't the only evidence that high-intensity phone interventions don't work in this setting. Even if they were to generate some improvement, they are so expensive that they can only be used for the sickest patients. So for now, we are left with the proven beneficial effects of less intensive patient engagement techniques that seek to keep patients connected with the practice and activate them when they need to be, rather than educate and prepare them ahead of time. It looks like the "teachable moment" may be more valuable than all the that coaching and preparation.


Blackberry ID, Furler JS, Best JD, Chondros P, Vale M, Walker C, Dunning T, Segal L, Dunbar J, Audehm R, Liew D, Young D. Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement and Coaching for Health (PEACH) pragmatic cluster randomised controlled trial. BMJ. 2013 Sep 18;347:f5272. doi: 10.1136/bmj.f5272.

Missing the diagnosis of CKD

The good folks at the Oregon Rural Practice Based Research Network looked through their database of lab results and found 865 patients with laboratory evidence of chronic kidney disease (CKD). Of these, 52% had no documentation of the diagnosis in the chart. CKD in women was missed more often than in men. Importantly, the care of high blood pressure was better in those CKD patients where the provider had documented the diagnosis.

What's going on? Is this just a documentation issue?  Probably not. We've seen the same phenomenon in several other clinical settings. It's related to the difficulty of interpreting serum creatinine levels, the complexity and relative newness of the diagnostic criteria for CKD, the permanent brain cramp for all things kidney that medical school renal physiology courses induce, and the presence of the creatinine test in larger panels that are used when kidney disease is not top of mind. So, like the Oregonians, we also found that the number of known CKD cases goes up by 80-100% when the creatinine is systematically looked at (in the form of the estimated GFR value).

You can't engage patients in the care of their kidney problems and prevent end-stage renal disease if you don't even recognize that the patient has kidney disease in the first place! Happily, there are systems to help, and they are effective, easy and inexpensive. Let me know if you want to know more.

Rao MK, Morris CD, O'Malley JP, Davis MM, Mori M, Anderson S. Documentation and management of CKD in rural primary care. Clin J Am Soc Nephrol. 2013 May;8(5):739-48. doi: 10.2215/CJN.02410312. Epub 2013 Jan 31.

Does CKD increase the risk for prostate cancer?

Here's one more reason to aggressively identify, manage, and stay connected to patients with chronic kidney disease (CKD): Prostate cancer. 

A recent study from Korea analyzed a group of men with elevated prostate-specific antigen levels (PSA 4-10 ng/ml). They were all biopsied, but those with stage 3-5 CKD (eGFR < 60) were more likely to have a cancer detected.

Although I'm not sure that PSA screening is a good idea in this population (or any others, for that matter), these findings are certainly disturbing. What isn't clear is whether our strategies for slowing the progression of renal insufficiency (especially blood pressure control and angiotensin inhibition) can prevent the development of prostate cancer.

Cho SY, Park S, Lee SB, Son H, Jeong H. Differences in prostate cancer detection rates according to the level of glomerular filtration rate in patients with prostate specific antigen levels of 4.0-10.0 ng/ml. Int J Clin Pract. 2013 Jun;67(6):552-7. doi: 10.1111/j.1742-1241.2012.03014.x.

"By the way...": The pros and cons of incidental findings

Melissa Healy wrote a very interesting story for the LA Times last week on what happens when a medical test reports something unexpected.You're looking for pneumonia and the chest x-ray shows a cancer in the spine, but you don't know where it came from. A head CT to rule out subdural hematoma after a head injury shows an aneurysm...that might or might not cause trouble one day. These "incidental findings" are disturbingly common.

High tech imaging tests like CT scans and MRIs are particularly prone to this because they are not very specific in their field of view and provide a huge amount of information. If you get a CT of the abdomen to look at the liver, you're going to get all sorts of information about the gallbladder, stomach, intestines, kidneys, pancreas, etc. even if you don't want it. In my experience, lungs and brains are particularly full of findings of "uncertain significance" that are time consuming, costly and difficult to evaluate. They certainly induce a huge amount of anxiety in the patient.Whole genome studies are going to be even worse. The vast majority of genetic information in a person is not interpretable with anything like the accuracy required for clinical decision making.

The new that stimulated Healy's article was that the Presidential Committee for the Study of Bioethical Issues said professional organizations need to start writing guidelines for how to deal with these incidental results. In other words, we should stop treating them like they are not anticipated - we know we are going to get them even if we don't ask for them, so we better make a plan.

I'm all for coming up with guidance on this tricky issue, especially in cases where the consequences of over-diagnosis and unnecessary work-ups are high and the benefits are low. 

The unintended uses of diagnostic tests have a few other upsides to keep in mind, though. They can be used for public health surveillance to help develop strategies for the whole population of patients. This is done routinely with infectious disease tests, for instance, to alert us to new outbreaks.  More recently, we have been systematically scanning commonly done blood and urine chemistry tests to identify patients with undiagnosed diabetes and kidney disease. In the case of chronic kidney damage especially, even the doctors don't always recognize the condition as present. By using an automated system to monitor laboratory results, we can identify patients who need extra attention, reach out to them, connect them to the resources they need and prevent emergencies and other complications.

If you have thoughts on this issue, do leave a comment!