The Big N

Picture from apple.com

In 2010, at age 65, after serving on a hospital board of directors for some years, I decided to go back to school and study healthcare. I received a doctoral degree four years later. During the final year, a requirement of the doctoral program was to conduct research and publish a dissertation. The title of my dissertation was Cardiac telemonitoring for the reduction of hospital readmissions for congestive heart failure patients.

One of the key elements of any research study is the size (referred to as the N) and statistical validity of the sample you study. For my study, in conjunction with a teaching community hospital, I identified 344 congestive heart failure patients who were assessed for inclusion in the cardiac telemonitoring study. Two hundred and eighty-eight patients were excluded for various valid reasons mostly involving nursing homes, 30 declined to participate, and 10 withdrew after having been included in the study. The result was an N of 16 patients who completed the study.

The result of the study provided significant insight to healthcare leaders. It provided a basis to develop new standards of care and lead to improved patient safety and a higher quality of care. The research could also result in improved quality of life for patients and their families. However, the goal of the study was to determine if home telemonitoring could reduce the number of hospital readmissions. My hypothesis was it could. Unfortunately, the N was not large enough to provide a statistically valid conclusion.

Millions of studies and articles occur. One study of studies said 85% of the studies were not helpful. There are numerous reasons why a study may be flawed. Bias can be introduced in the way study participants are selected. For example, one reason is a study may be trying to prove something and the study participants are paid. Another major reason a study may not have valid conclusions is the lack of a big N.

A federally funded, international study, with results released this past week, found no evidence patients with severe but stable heart disease who underwent heart procedures experienced lower rates of major, disease-related events compared to those treated with medications and lifestyle changes alone. The study randomly assigned 5,179 patients at 320 sites in 37 countries to receive one of the two treatment strategies. The study was more than twice as large as any previous study of its kind. Studies with a big N can be more valid, but they are expensive to conduct.

Enter Apple, showing its appetite for keeping us healthy (and selling lots of iPhones and Watches), which has announced a new model for research. This past week, Apple introduced three unprecedented medical studies, in partnership with leading academic and research institutions, which will reach more participants than has ever been possible. The studies will be available on the new Research app, which democratizes how medical research is conducted by bringing together academic medical institutions, healthcare organizations, and Apple iPhone users. Since hundreds of millions of people have already made iPhone apps a part of their everyday life, enabling them to participate in medical research is a natural. Participants will contribute to potential medical discoveries and help create the next generation of innovative health products. The Research app is free and available in the App Store.

With the Apple Heart Study conducted a year ago, the company demonstrated it could positively impact medical research in ways which help patients today and make research contributions which may benefit future generations. Instead of an N of a dozen or hundreds or even thousands, the potential now will be N = millions. There will likely be many studies which will appear in the Research app over time. The three new studies just announced include the following.

  • Apple Women’s Health Study: In partnership with Harvard T.H. Chan School of Public Health and the NIH’s National Institute of Environmental Health Sciences (NIEHS), Apple has created the first long-term study of this scale focused on menstrual cycles and gynecological conditions. This study will inform screening and risk assessment of conditions like polycystic ovary syndrome (PCOS), infertility, osteoporosis, pregnancy and menopausal transition.
  • Apple Heart and Movement Study: Apple is partnering with Brigham and Women’s Hospital and the American Heart Association on a comprehensive study of how heart rate and mobility signals — like walking pace and flights of stairs climbed — relate to hospitalizations, falls, heart health and quality of life in order to promote healthy movement and improved cardiovascular health.
  • Apple Hearing Study: Alongside the University of Michigan, Apple is examining factors that impact hearing health. The Apple Hearing Health Study is the first of its kind to collect data over time in order to understand how everyday sound exposure can impact hearing. The study data will also be shared with the World Health Organization (WHO) as a contribution toward its Make Listening Safe initiative.