mHealth Needs Scientific Health

This is an unusual topic for a blog, but needs publication and familiarization. The world of mHealth is growing everyday and according to Dr. Robert M. Kaplan needs to be done with good scientific health behind it. He feels that there is real scientific value once we move away from the hype.


I agree with him, as there is too much hype surrounding much of the mobile health devices on the market today and much of the hype is just to prevent you from seeing how little value or usability is in the devices. This is part of the reason the Office of Behavioral and Social Sciences Research (OBSSR) in the Office of the Director, NIH (National Institute of Health) was created by Congress in 1995.


The OBSSR mission is to stimulate behavioral and social sciences research throughout NIH and to integrate these improving our understanding, treatment, and prevention of disease. Read the full mission statement here.


There is a lot of excitement surrounding the use of new mobile and wearable health information and sensing technologies. Their potential to enhance health research, improve health, while also reducing the cost of health care is needed. However, strong scientific research is needed to examine their potential and challenges of their use. This will put companies on notice that hype will not get them a pass to use.


The OBSSR has funding opportunities to help in the development of devices that can fulfill these goals and this can be read here. Unfortunately, it is not all about devices, but includes social sciences and behavioral sciences as well. Take time to explore the site.

Is the Doctor-Patient Trust On Life Support?

The answer is not a straightforward yes or no, but is dependent on where you live, your current age and whether you have good insurance. Yes, Medicare is considered insurance, but some doctors are no longer accepting patients on Medicare. And here I am not including doctors that are operating on contract medicine. In largely rural areas, often the patient must travel long distances to see a primary care physician or even further to see a specialist.


If you live in a doctor dense area, then you have an easier task of finding a doctor that may be the right fit for you. Under the law changes happening because of the Affordable Care Act, the next couple of years may be difficult for some patients. As the changes take place, some patients may become dissatisfied with the doctors they are required to see, as it appears there will be a team approach once you become a more complex patient with two chronic illnesses or diseases. Once you are on Medicare, this may become even more problematic.


No one can say with certainty how we will be affected by the physician shortage or where the physician shortage will be in relation to the population most needing physicians. Many physicians are leaving private or small practices for employment with hospitals. Other physicians are leaving smaller towns for larger cities and larger practices. A few are setting up small practices in larger communities.


Dr. Shirie Leng has a blog about the doctor-patient relationship and why the trust is waning in this relationship. While she does not become severe about patients, I may be reading between the lines, but I do come away with the feeling that she feels many patients would be better off putting more trust in their doctors.


Her statement here is very much on target. “Trust has many components. It is based partly on compatible communication styles. The Journal of General Internal Medicine points to the patient’s assessment of the physician’s communication, level of interpersonal treatment, and knowledge of the patient. In these times of short visits, short-tempered doctors and patients, and fragmented treatment, all those factors are in jeopardy. Patient dissatisfaction implies poor trust. Race and gender of both patient and doctor has an impact. Patients who genuinely like their doctors tend to trust them more.”


Dr. Leng does balance the scale when she uses information to put her own profession in a poor light when she talks about the paternalistic approach to medicine. Does she mean that female doctors are better? I had to ask this question as I have seen both sides of this issue and the bad female doctors are often worse that male doctors in similar situations. Yet on balance, more female doctors empathize with their patients than male doctors ever have.


In the 1950's, it was thought that physician trust was based on doctors treating everyone equally. Today the media has promoted this as not true and that there are other reasons to be concerned, such as regional differences in the standard of care.  A number of stories are used for breaking this thought. Doctors that over-prescribe, take money from drug companies, and turn down Medicaid patients are just a few of the things the media makes sure we are aware of.


All the data is soft and outdated in the research on doctor-patient trust. Current discussions suggest doctors are losing ground on this issue. The following things might help a little: (I will quote Dr. Leng's ideas, as they are relevant.)
1. “Doctors cannot take money from drug companies. Ever. Not even a pen. Just don’t do it.
2. Practice good communication, or learn how if you don’t know. This goes on both sides. If you don’t understand, ask. If you are the patient, bug the doctor until you are satisfied. If you are the doctor, ask and answer for as long as it takes.
3. Take money out of the conversation. Universal health care is the only way to do this successfully.
4. There is nothing wrong with finding a doctor who is the same gender or ethnicity as you.
5. Understand that nobody has all the answers. Doctors don’t know everything, patients don’t always know what they want, and none of us like this fact. We like to think medicine is an exact science but it is not.
6. Doctors must keep up with the latest real research. We must go to our annual conferences. Where I work, the only people who get to go to the annual conference are the people who are presenting, who are the researchers, who always go, and who do less clinical work. No. Everyone goes. Close the ORs. Close your office. Can’t afford to close your office? Use the databases like UpToDate, which has a hundred doctors employed solely for the purpose of gathering the latest clinical info.
7. Tort reform. All the research and conferences in the world don’t do anything if people are afraid to follow what the research says.
8. Patients cannot expect miracles. Those days are over. Patients cannot expect that they can get every test and treatment known to man. Those days are over too.
9. Let’s all recognize our humanity.”

What Is A Patient to Do – Provide BG Data?

This has been a sore point with me and several of the “diabetes coaches” I have come across in the last few years. Of the five, four were of the opinion that you should never take your blood glucose meter to a doctor appointment. They felt that this was your information and the doctor did not need it. The fifth said take it or not, it was your data and it was up to you whether you shared it or not.


Now I understand why I could not do business with these “diabetes coaches.” I have always been one that believed the more eyes on the data, the better I would be, because what I missed, the doctor might catch and prevent problems down the road. Plus, I have found it easier to convince the doctor that I was doing things correctly and not to be so uptight about my A1c's. This is because they worry too much about hypoglycemia. I am glad they have the concern, but as long as I don't have severe episodes, I don't get concerned about readings above 55 mg/dl. Below 55 mg/dl, even I have concern. They worry about anything below 80 mg/dl and with the new guidelines for 70 mg/dl they had better not complain about mine above 70 mg/dl.


This study, presented at The Endocrine Society Annual Meeting and Expo; June 15-18, 2013 in San Francisco does point out that those that bring their meters to their appointments, have a lower A1c than those that don't. The difference is significant at 1.2% less for those that brought their meters to appointment for Medicaid and Medicare patients.


Therefore, I will continue doing what I do and bring my meter, which is downloaded and the data used during my appointment. And I will continue to stay away from “diabetes coaches” that advise not taking my meter.

When Does Hypoglycemia Happen?

This is another reason many, if not most, doctors will not prescribe insulin. It seems this is the nemesis that many doctors just can't accept because once the patient leaves the office; they are no longer in control. Hypoglycemia has now been proven to happen at any level of HbA1c and this can only make physicians more nervous. The upsetting information for me is that this is for type 2 diabetes patients.  The study did included several ethnic groups and was evenly divided between male and female.


This study, DISTANCE (diabetes study of Northern California) was a survey. Making the study more useful was the fact that the survey data was linked with clinical, pharmacy, and laboratory data from participants' electronic medical records. The researchers studied the relationship between HbA1c levels and hypoglycemia using a sample of 9094 diabetes patients between the ages of 30 and 77. The patients were from Kaiser Permanente Northern California and were surveyed in 2005 and 2006.
They were treated with glucose-lowering medications in a usual care setting. The patients were asked about severe hypoglycemia requiring assistance during the prior year.


Dr. Kasia Lipska of Yale University, and colleagues reported that as many as 10 percent of patients with type 2 diabetes reported experiencing severe hypoglycemia. Dr, Lipska reports that the risk is high across all levels of glycemic management. Instead of the usual expectations of hypoglycemia being more of a concern as patients are brought to normal glycemia levels, the survey showed that patients at the highest risk of hypoglycemia also included those with very poor glycemic management.


The authors note, few studies have indicated any conclusive relationship between patients in the usual care setting and changes in glycemic management. The duration of diabetes was based on self-report and was categorized as "10 years or less" or "more than 10 years." Participants were evenly split between men and women. The majority of patients were older than 50, with 32.2% of participants ages of 50 to 59 and 33.7% of participants ages 60 to 69.


Participants with diabetes for more than 10 years were more likely to report severe hypoglycemia than those with a duration of 10 years or less (13.9% versus 8.3%). Hypoglycemia was most common in patients receiving insulin therapy (19%) and least common among those using oral glucose-lowering therapies (5.8%). Despite those differences, there was no distinguishing relationship between HbA1c and age, diabetes duration, or category of diabetes medication. Regardless of what you may have read before, hypoglycemia occurs just as often among those with poor blood glucose management as it does for those with excellent blood glucose management.

Guidelines and Those That Develop Them

When I read this by Dr Malcolm McKendrick, I had to think how like some other guideline committees I have written about lately. Dr. McKendrick writes about the group that wrote the cholesterol guidelines and how they attempted to hide the conflicts of interest that those on the guideline committee had. For that digging and forcing the issue, I hope that I am able to properly thank Dr. McKendrick someday.


This paragraph from Dr. McKendrick's blog really makes the point. “In 2004 this committee decided that cholesterol levels should be lowered far more aggressively than in the past. Based on, as far as I could see, very flimsy evidence. Could it be that that committee was, in some way, biased in favour of cholesterol lowering companies? A number of people, including me, demanded to see if any of the eight invited members of this hugely important committee had financial conflicts.”


Yes, they certainly did have financial conflicts and this has to mean that there needs to be more concern about statins our doctors insist that we consume.


This type of digging was necessary for the American Association of Clinical Endocrinologists diabetes algorithms issued on or before April 24, 2013. At first they did not give out any information about the algorithm, conflicts of interest, and missed many points. After a Medscape article and a New York Times article, they still took over a month to issue a consensus statement for the algorithms. Many points were still omitted because they won't accept them as being what happens in the real world. Yet many of us with type 2 diabetes know better and think that the members of the committee are out of touch with what happens outside their towers.


Members of our support group have been thinking that we are the fortunate ones to have doctors that do not completely align themselves with the AACE. We are in agreement that people with conflicts of interest have no business being on committees that develop algorithms or guidelines because we know the bias they bring to the discussions. Whether it is true or just supposition on our part, we feel that some of the conflicts result in extra fees for many of the committee members.


I personally feel that if they had issued a consensus statement with the algorithms, there may have been less criticism, but the criticism they received was well placed and pointed out the shortcomings of the algorithms. It showed us how incomplete the algorithms are in opposition to Dr. Garber's “comprehensive” statement.