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"N-of-1 or single subject clinical trials consider an individual patient as the sole unit of observation in a study investigating the efficacy or side-effect profiles of different interventions. The ultimate goal of an n-of-1 trial is to determine the optimal or best intervention for an individual patient using objective data-driven criteria. Such trials can leverage study design and statistical techniques associated with standard population-based clinical trials, including randomization, washout and crossover periods, as well as placebo controls. Despite their obvious appeal and wide use in educational settings, n-of-1 trials have been used sparingly in medical and general clinical settings. We briefly review the history, motivation and design of n-of-1 trials and emphasize the great utility of modern wireless medical monitoring devices in their execution. We ultimately argue that n-of-1 trials demand serious attention among the health research and clinical care communities given the contemporary focus on individualized medicine. Keywords: clinical equipoise, early-phase trials, individualized medicine, n-of-1, remote phenotyping, single patient trial, treatment repositioning, wireless health"

"Sharfstein, too, thinks that it's fair to criticize the federal government for not recognizing that its pandemic plans had a single point of failure. The C.D.C. quickly developed a working test, and it was understandable, at some level, that people at the Centers thought that fixing the faulty reagents for the public-health labs would be faster than shifting to an entirely different protocol. Nevertheless, Sharfstein said, "Why are we relying only on the C.D.C.? What the F.D.A. could have done, and eventually did do, is say, 'You can use other approaches.' " Even so, he said, "I don't think it's quite fair to totally blame the F.D.A. for this. The F.D.A. can design an approach to support the public-health strategy, but someone has to tell F.D.A. the public-health goal." The delay in clearly establishing those goals, he said, shows why the decision to shut down the N.S.C. directorate was so consequential. "People talk about, like, why does it matter that they closed the White House office on pandemic preparedness? This is one reason.""

DeAunne Denmark, MD, PhD - Magnificent resource N-of-1 guide An interactive explainer on what N-of-1 is and it's purpose.

Open Access. Abstract Introduction: Critical for the diagnosis and treatment of chronic pain is the anatomical distribution of pain. Several body maps allow patients to indicate pain areas on paper; however, each has its limitations. Objectives: To provide a comprehensive body map that can be universally applied across pain conditions, we developed the electronic Collaborative Health Outcomes Information Registry (CHOIR) self-report body map by performing an environmental scan and assessing existing body maps. Methods: After initial validation using a Delphi technique, we compared (1) pain location questionnaire responses of 530 participants with chronic pain with (2) their pain endorsements on the CHOIR body map (CBM) graphic. A subset of participants (n = 278) repeated the survey 1 week later to assess test-retest reliability. Finally, we interviewed a patient cohort from a tertiary pain management clinic (n = 28) to identify reasons for endorsement discordan

Galileo Design and Run Experiments with people from around the world N=1 Cohort Participants - Set up your account and create your first N=1 experiment.

"Sitting in freezer at Boston Children's Hospital is a drug you won't find anywhere else. It's called milasen, and the 18 g that the hospital custom-ordered nearly 2 years ago should last for decades. That's because milasen was designed to treat a single patient-a now 8-year-old girl named Mila Makovec. Milasen was built on decades of work on a class of drugs called antisense oligonucleotides. But after Boston Children's Hospital scientist Timothy Yu diagnosed Mila with a never-before-seen genetic mutation, he took only 10 months to go from idea to injection. It's a record-shattering sprint in the typical drug-development marathon, and an unprecedented degree of personalization for a chemical drug."

ERIC J. DAZA Digital WISDOM: Esametry An n-of-1, single-case, or single-subject study is an idiographic, within-individual study of one person's recurrent characteristics and patterns under various exposure or treatment conditions. These exposure periods make up repeating intervals that can be accurately described as a set of partitioned time series of variables (e.g., outcomes and predictors). The core idea is that there are stable periodic or cyclic patterns that are predictable.

"This pandemic has been studied more intensely in a shorter amount of time than any other human event. Our globalized world has rapidly generated and shared a vast amount of information about it. It is inevitable that there will be bad as well as good data in that mix. These massive, decentralized, and crowd-sourced data can reliably be converted to life-saving knowledge if tempered by expertise, transparency, rigor, and collaboration. When making your own decisions, read closely, trust carefully, and when in doubt, look to the experts."

"There is great interest in and excitement about the concept of personalized or precision medicine and, in particular, advancing this vision via various 'big data' efforts. While these methods are necessary, they are insufficient to achieve the full personalized medicine promise. A rigorous, complementary 'small data' paradigm that can function both autonomously from and in collaboration with big data is also needed. By 'small data' we build on Estrin's formulation and refer to the rigorous use of data by and for a specific N-of-1 unit (i.e., a single person, clinic, hospital, healthcare system, community, city, etc.) to facilitate improved individual-level description, prediction and, ultimately, control for that specific unit."

"Prospective consent and governance principles for participant-led research Nine themes emerged from discussions and interviews relating to informed consent in and governance of PLR. As this PLR was driven by people with different backgrounds asking personal questions, we found that ethical reflection needed to be ongoing and tailored to the individual. For this reason, prospective governance principles were drafted rather than codified rules. Many of the themes were expressed over the course of our PLR as an ongoing informed consent. The process, fostered via frequent communication, helped to reinforce trust among participants and organisers.43 44 Transparency: All relevant information about the project should be actively shared among participants and participant-organisers, including the source of research funding, equipment selection, data management protocols, risks and benefits and conflicts of interest. Access to Expertise: Participant-led research (PLR) requires access to experts (eg, in experimental design, data analysis, research ethics) so that participants can rigorously carry out single-subject experiments.45 Data Access & Control: The participant has the right and ability to manage their own data, and has the final say in what they collect about themselves. Right to Withdraw: Participants have a right to reduce or withdraw their participation at any time. Relevance: PLR addresses questions of relevance to the participants. Beneficence: The participant actively reflects on the balance of benefits and risks of participation and freely choose whether to participate. Responsibility: PLR requires that the participant actively consider the potential benefits and harms of the project to both themselves and others. The responsibility to stay informed is an ongoing process, not a one-time decision. Flexibility: Ethical reflection in PLR should be tailored to individual needs and to the specific context, rather than be handled with 'one size fits all�

"We hear a lot about how big data, smart devices, and all the '-omics' (for example, genomics, proteomics, metabolomics, and so forth) are going to transform medicine-and they will. But there is another force that is going to change the way we think about and practice health, and that is our small data-small data derived from our individual digital traces."

"In 2009, Ms. Leon went to the WomenHeart Science and Leadership Symposium at the Mayo Clinic, where she met Dr. Sharonne N. Hayes, a professor of cardiovascular medicine at Mayo. At that time, the largest study on SCAD included 43 patients. "I walked up to Dr. Hayes and told her we had 70 people, and we wanted research," Ms. Leon recalled. "She was like, 'Wow.'" "Everything I learned about SCAD in my medical training was wrong," Dr. Hayes said. By 2010, with the help of Dr. Hayes, and subsequently SCAD Research Inc., an organization founded by Bob Alico, who lost his wife to SCAD, Dr. Hayes devised an innovative way to do research, using online networks of far-flung patients and analyzing genetic and clinical data. "We never imagined there would be 1,000 female patients in our virtual registry," Dr. Hayes said."

Here is the 'on the fly' video of our encounter with Master Lu. Jan wore the gut monitor for the short session in Oceanside. She followed up with a much longer (1 hour) session with Master Lu two days later. She was able to walk without a cane for the first time during those sessions. Subsequently she has been able to walk (in PT) barefoot without a cane.

"n the nearly 20 years since the publication of this report, numerous stakeholders have sought to reinvent and redesign the US health care system to make it, as the report called for, safe, effective, patient-centered, timely, efficient, and equitable. Researchers have engaged in rigorous and innovative assessments to identify promising approaches. Policy makers, practitioners, and payers have made changes to health policy and clinical practice and instituted various payment reforms and demonstration programs. Yet, despite the tremendous work of the past 20 years, we have not achieved a health care system that is truly patient centered and equitable."

"We leave a trail of digital data breadcrumbs as we go about our days. With access and good apps, we could make sense of this "small data" to help get a clearer picture of our personal health. Deborah Estrin, networked sensing pioneer, Professor of Computer Science at the new Cornell Tech campus in New York City and co-founder of the non-profit startup, Open mHealth, explains at TEDMED 2013."

This YouTube Edition should work! Here is the 'on the fly' video of our encounter with Master Lu. Jan wore the gut monitor for the short session in Oceanside. She followed up with a much longer (1 hour) session with Master Lu two days later. She was able to walk without a cane for the first time during those sessions. Subsequently she has been able to walk (in PT) barefoot without a cane.

I'll be posting some video of Janice walking shortly after seeing Master Lui (soon). ~ Dennis

THE QUANTIFIED SELF is about making personally relevant discoveries using our own self-collected data. We call this practice everyday science, a name that emphasizes its nonprofessional character. Lately we've begun organizing small group projects that show how collaboration can make individual projects easier. Sometimes, joining forces with others who share our question can make it possible to create both personal and generalizable health knowledge. Following the scholar Effy Vayena, we use the term "participant-led research" (PLR) to describe this approach.

Recommended by Dr. Michael Kurisu D.O.: ...the owner of the blog is Eric Daza DrPH. He is a biostatitician that does modeling on causal beliefs for Nof1 studies for individuals.