Why I Started
I started running 15 weeks ago because I decided to do the opposite of what I felt like doing. I was exhausted after teaching a 1-week course and, when resting didn’t help, I decided to run. I was already exercising, so, when I tried Couch25K, which my son recommended, I was beyond “couch”. But my previous attempts to run had been not serious (in college), had been at too fast a pace to sustain (a few years ago), or purely in my head (New Year’s resolutions). The latter seems to be common; when I told people I was running, many said, “I’ve been thinking of starting too.” It’s like when people view modern art and say, “I can do that.” But most don’t.
Using the language of Transtheoretical Model of Change, these people are at the precontemplation stage. I was too, until I started my “Do the Opposite” plan. The other stages are contemplation, preparation, action, and maintenance. I am solidly at the action stage.
What I Have Accomplished So Far
Even though I didn’t follow Couch25K, it made me aware of starting slow and building up. I knew the importance of a schedule thanks to my runner husband, Mike, and the exercise class I’ve been going to for years. I committed to running three times a week, and have only had one time I run twice (and a few I’ve run four times).
While my first run was six minutes, I have now completed a 5k. My longest run was 1:04:13, which included going up Nob Hill in San Francisco. I called this “breaking the one-hour barrier,” after reading about (the very different) “Breaking the Two-Hour Marathon Barrier.”
I have run in the rain, which seemed unappealing, but wasn’t bad after the first minute. I have run in heat and humidity – I started in August – and on crisp, fall days. I understand why runners say that fall is their favorite season.
Why I Persisted
It was great to see progress: I was able to go on longer runs and rarely felt tired at the end. It was really fun to run with Mike, who would run at my pace, not his own faster one. I especially liked running when we travelled – the aforementioned one at APHA in San Francisco and another in Montreal. Because I go to an exercise class, I generally don’t exercise when travelling, arguably when I need it most. Running is also a great way to see a city.
Sometimes I found running boring, although less so the longer I do it. I tried listening to music, and tried thinking about something specific (that was how I wrote this – in my head, while on a run).
I tried apps for running and didn’t like any of them. They took more effort to configure than seemed reasonable given that I just wanted to try them, and they asked for my height, weight, and age without telling me how the information would be used (apparently only to calculate how many calories I burned). Their tracking didn’t motivate me because I already had a sense of accomplishment at the end of each run. The reminders I still get from the apps would be unlikely to motivate me if I had started running and then stopped, as the apps believe. (I would like to think further how app design can incorporate Transtheoretical Model of Change in my Mobile Health Design course next summer.)
However I used Twitter and Facebook to informally track my runs, and loved the support and encouragement I received. It was fun to run into friends and colleagues who had not commented online but congratulated me on my running accomplishments. The funniest was when I saw a friend a few days after my 5k and she did a celebratory dance, singing my finish time. I have made new friends too, like Boston Globe writer and runner Elizabeth Comeau.
I am at the action, not the maintenance, stage; I feel committed to continuing but it feels a little tenuous. Mike surprised me once with new running clothes, and I also bought a long-sleeved running shirt in one of my favorite colors, thinking about Janet Wasserstein, who told me that she played better tennis in stylish tennis outfits. With the days getting colder, I need to avoid deterrents, and cold is definitely one of them.
I sometimes catalogue the benefits of running to keep myself from slipping out of the action stage. I like how running is a barometer of how I feel: what’s on my mind, did I get enough sleep? I enjoy being outside and moving, especially given how much I sit the rest of the day. My ”skinny jeans” fit the same, although I assume running has many health benefits for me. I am still working on how my insights can be incorporated into the design of my “Do the Opposite” app for new runners.
It seems like I’ll be at the maintenance stage when I actually look forward to running, not to being done. For right now, I like the sense of accomplishment.
One of the most fascinating things about health apps is the process of selecting them: defining the need, determining how to search and which search terms to use, deciding which to consider, and deciding which to try. Having thought a lot about health app search, I was thrilled to have an opportunity to talk about the broader issue of mobile health search in a session at APHA12 on health information seeking.
My presentation first argued that it is almost impossible to focus only on laptops and desktops when considering health information seeking given the preponderance of mobile devices. I then talked about what mobile devices provide health seekers:
- Immediacy and access
- Multiple methods of input/output
My slides are posted here. Many thanks to Susannah Fox and John Mangano for sharing Pew and Comscore data respectively.
I was curious why Lahey Clinic, a nonprofit group practice outside of Boston, started asking patients, “Are you safe at home?” during intake. Trying to find this out turned into an exploration of the inconsistent state of intimate partner violence screening in the US.
“Are You Safe At Home?”
The first time I was asked “Are you safe at home?” during patient intake at Lahey Clinic, I was surprised that such a personal question was asked in such an impersonal way – by a healthcare professional hunched over a laptop and not making eye contact with me (which inspired a blog post on the role of eye contact in physician-patient communication). It seemed like the only purpose of the question was to check a box on an online form to show that they had screened for intimate partner violence (IPV), the au courant term for domestic abuse. When and why was “Are you safe at home?” added to Lahey’s patient intake process?
Finding the answer to my questions turned out to be surprisingly elusive:
- When was “Are you safe at home?” added to patient intake?
- Is it used for all ages and genders?
- Is the question included in the EMR?
- Is it required by law or by accrediting agencies?
- Why was IPV screening added to patient intake?
- Who asks the question and what training are they given about how to ask? Are they screening for IPV in other ways?
- What wording and method of asking is most effective?
- What protocols are in place if a patient answers in the negative or reacts with a response other than “Yes”?
- Has data been collected on the answers and on the actions taken, or on the impact on detecting IPV?
I became interested in the answers, not just for Lahey, but for all hospitals and doctor’s practices.
IPV Screening May Be Required for Hospital Accreditation
I asked a nurse practitioner at Lahey Clinic, who said “Are you safe at home?” was added about two years ago and was asked of both men and women. She thought it was required as part of The Joint Commission’s (JCAHO) accreditation process and that when Lahey is up for review they need to show that all patients were asked. The nurse practitioner said that she did not know of a formal protocol if a patient said they were not safe at home and would have to decide on the spot to notify the police or social services. She further said that some patients get angry when asked because they see it as an invasion of privacy, and she speculated that these strong reactions might indicate a problem.
I learned more about JCAHO, which certifies hospitals and other medical facilities based on adherence to quality standards. Lahey was last accredited in November 2011, and the full report is available as are the accountability measures, which focus on patient safety initiatives, but not on IPV (that I could find). The results from the Survey of Patients’ Hospital Experiences were also available. (Since this was more recent than what was reported on Lahey’s site, I wondered if people actually check hospital survey results or for JCAHO accreditation. My curiosity led me to How to choose a hospital where JCAHO was listed as one of four other sources of information about hospitals to check besides Consumer Reports’ own ratings). Lahey’s commitment to IPV goes beyond the screening question, as indicated by their provision of Domestic Violence Resources as part of patient information and their Domestic Violence Initiative. Other Greater Boston hospital websites I looked at did not provide this information or it was more buried in their site.
Government Agencies Recommend IPV Prevention and Screening
JCAHO’s website led me to patient safety initiatives from The Agency for Healthcare Research and Quality (AHRQ) and to an Institute of Medicine (IOM) report, Clinical Preventive Services for Women: Closing the Gaps, that recommends to the US Department of Health and Human Services that women’s preventive services include screening and counseling for interpersonal and domestic violence in a culturally sensitive and supportive manner.
As early as 1992, the American Medical Association (AMA) issued non-binding guidelines that advised doctors to routinely question female patients about domestic violence and that they should consider the possibility of domestic abuse if patients provided “unlikely stories for how sustained an injury.” The guidelines addressed the actions a physician should take before the patient leaves the office. More recently, in November, 2007, AMA Policy E-2.02 Physicians’ Obligations in Preventing, Identifying, and Treating Violence and Abuse was adopted. It included the identification, treatment, and reporting of abuse and mentions the need to extend this to emotional abuse or neglect and to “patients who do not belong to population groups that are traditionally believed to be at risk of abuse”. Specifically, it said that:
Physicians should routinely inquire about physical, sexual, and psychological abuse as part of the medical history. Physicians should also consider abuse as a factor in the presentation of medical complaints because patients’ experiences with interpersonal violence or abuse may adversely affect their health status or ability to adhere to medical recommendations.
Another AMA report that referred to the 2007 guidelines stated that “Research results indicate, however, a high rate of missed opportunities for patient identification in clinical settings.”
About 25% of Woman Are Victims of IPV at Some Time
Amy LaVertu, MLS, an Information Services Librarian at the Hirsh Health Sciences Library at Tufts University, conducted searches to help me with my IPV research. (The use of multiple terms, including intimate partner violence, partner violence, domestic violence, and domestic abuse, made searching more difficult for both Amy and me.) Amy found out about the mandatory reporting laws that some states like California have that require health practitioners to report any known or suspected abuse but do not specify screening processes. Amy also found data about the incidence of IPV; US Preventative Services Task Force (USPSTF) reported, “It is hard to know exactly how many women experience IPV because it is not always reported. However, it is thought that between 1.3 and 5.3 million women experience IPV every year. About 25 percent of women experience IPV at some time during their lives.” This highlighted the extent of the problem as well as the need for consistent reporting, and made me yet again wonder what happens to the screening data from Lahey and other institutions.
IPV Screening Takes Many Forms
The recommendations about screening did not specify the wording or timing of screening. Through searches I located many patient intake forms that included the question “Are you safe at home” One was from Fenway Health in Boston, so I contacted Chris Viveiros, a former student, who is Fenway’s Associate Director of Communications. Chris found out from his colleagues that the online form “isn’t Fenway’s actual patient intake form. ‘The Fenway Guide to LGBT Health’ is a medical textbook that Fenway produced and published in conjunction with the American College of Physicians and the form was included in that textbook as a model form that others can adopt.” Chris checked with Fenway’s medical and behavioral health departments, and found that neither department includes that question on their patient intake form. Fenway’s Violence Recovery Program coordinator elaborated, “The Behavioral Health forms actually ask a series of questions about potential partner abuse developed from the screening tool the Violence Recovery Program uses to assess domestic violence.” Instead of “Are you safe at home?”, for over five years they have used a series of direct questions about what a person may be experiencing.
Another former student, Niranjan Karnik, MD, PhD, said that the recognition in the 1970s and 1980s of domestic violence as a public health issue is what led to the interest in screening. He guessed that each hospital creates their own intake forms, and pointed out that at University of Chicago Medicine, where he practices, “there are different intake forms for each clinic or department. In psychiatry we do not ask this question in this form; instead we tend to screen for childhood abuse as well as present abuse under the general rubric of past psychiatric history or social history.” Niranjan summarized my pursuit perfectly, saying “One over-arching issue to consider is how decentralized and fractured the US health care system is so that there is not one answer to these questions but many depending on individual institutional histories.”
Evidence That IPV Screening Works
Wanting to learn more about the accuracy, efficiency, and acceptability of screening processes, I read a systematic review update of the USPTF’s report on IVP screening in the Annals of Internal Medicine that states:
In conclusion, screening instruments designed for health care settings can accurately identify women experiencing IPV. Screening women for IPV could reduce IPV and improve health outcomes depending on the population screened and outcome measured, although effectiveness trials have important limitations. Screening has minimal adverse effects, but some women experience discomfort, loss of privacy, emotional distress, and concerns about further abuse.
Since I had initially been concerned about eye contact when screening, I was particularly interested in the comparison of delivery methods; the review stated that “higher rates of IPV disclosure resulting from self-administered methods than face-to-face questioning. Computerized screening increases rates of IPV discussion, disclosure, and service provision and is more acceptable for patients.” I wasn’t sure how these results fit with the findings in a JAMA article on the effect of computerized screening for partner violence on physical and mental health that concluded: “Among women receiving care in primary care clinics, providing a partner violence resource list with or without screening did not result in improved health.” Clearly more research needs to be done on screening effectiveness. I further wondered if any research on screening methods looked at the research reported in “The Media Equation: How People Treat Computers, Television, and New Media Like Real People and Places” by Byron Reeves and Clifford Nass, “The Man Who Lied to His Laptop: What Computers Can Teach Us About Human Relationships” by Clifford Nass, and other research on how people relate to technology.
What Helps People Who Are Being Abused?
When I spoke to Libby Bradshaw, DO, MS, my colleague in the Department of Public Health and Community Medicine at Tufts University School of Medicine, she focused on what most helps people who are being abused. As an ER physician, Libby used the Transtheoretical Model of Behavior Change (TTM) to assess which stage the person was at. (The five stages of change are precontemplation, contemplation, preparation, action, and maintenance.) At the precontemplation stage, she said, one can raise awareness and help people identify themselves as victims. Libby would say to someone she suspected was a victim of abuse, “I’m concerned about your safety and anyone’s safety who has injuries like yours” to open a door to disclosure. Another colleague, Marcia M. Boumil, MS, JD, LL.M., agreed with Libby and talked about the value of deflection and repetition. Both Libby and Marcia said that it is important to be sensitive to sending someone home with literature and that a wallet card is often better than something larger.
Tara Montgomery, Director, Health Partnerships & Impact at Consumer Reports, sent me The Minnesota Center Against Violence and Abuse paper, Building Bridges between Domestic Violence Advocates and Health Care Providers, which promotes collaborations between domestic violence advocates and health care providers that answer questions including: “Will this program or policy make battered women safer?” and “Will this program or policy make all women safer?” (The paper, written in 1999, uses terminology, like “battered women”, that is rarely used today.)
IPV Prevention and Screening
We have moved beyond the notion of “battered women” to include both physical and emotional abuse and to acknowledge that this is a public health problem that crosses all boundaries and must be taken seriously because, as Libby pointed out, victims of abuse have been killed. Many organizations are focusing on prevention, notably Healthy People 2020, which includes, as developmental objectives, the reduction of physical violence, sexual violence, psychological abuse, and stalking by current or former intimate partners.
A component of prevention is increasing awareness, which, as I learned through my research, is being done through traditional approaches (posters, flyers on bathroom stalls, brochures, and wallet cards) and more recent ones (websites, social media such as CDC’s VetoViolence campaign on Facebook, app challenges such as Ending Violence @ Home, Teen Dating Violence Awareness Month, and Domestic Violence Awareness Month). Libby was on the board of directors of Jane Doe Inc., The Massachusetts Coalition Against Sexual Assault and Domestic Abuse. Their website has a “Leave this site quickly” tab, acknowledging that someone viewing the site might not be in a safe situation, and extensive information on how to find help. While some of the site is focused on women, they balance the need to be inclusive while being specific enough to provide helpful services.
I returned to Libby’s excellent point about what best helps victims of IPV reach and move past the precontemplative stage of TTM to the action stage. From what I learned from Niranjan about University of Chicago Medicine, from Chris about Fenway Health, and from the nurse practitioner about Lahey Clinic, it seems that the use and wording of a screening question is based on, as Niranjan put it, “local practice and perceived needs”. Everything I learned leads me to believe that more standardized, evidence-based processes screening processes are needed. If screening instruments work, as the Annals of Internal Medicine review found, then what is the best wording to use to elicit a disclosure and the best delivery method (and does eye contact increase disclosure)?
Could more standardized screening processes lead to better reporting? The many constituents, including JCAHO, AMA, USPHS, CDC, hospitals, advocacy groups, and providers, differ in their goals and how they shape practice patterns. (I would like to make a flow chart showing where IPV decisions are made and the paths through which they reach institutions, health care providers, and patients.)
“We Do Not Have the Ability to Know Everything”
Niranjan said, “Invariably organizations are forced to make choices and what to ask and how much to dig because we do not have the ability to know everything. Who makes these choices about what is on a form is often less clear, and that opacity is what you found along your journey. A clerk may be tasked with creating a form, or a committee of physicians and nurses. There is little in the way of standard of practice for the development of medical infrastructure (I use this term in the broadest sense to include forms, apps, programs, charts, physical space and technology), and yet there is so much of the outcome that infrastructure determines.”
Healthcare professionals have a unique opportunity to identify IPV early to break the cycle of physical, psychological, and sexual violence. Requiring IPV screening in all states and all hospitals and doctor’s practices is a huge step in the right direction. But, in the spirit of evidence-based medicine, more research must be done to determine the specific IPV screening procedures and protocols that are most effective in detecting IPV and helping victims of abuse.
Behind the headlines “FDA Panel Unanimously Rejects…” and “Arthritis Pill From Pfizer Wins Support…” was, for me, over 600 pages of reading and two days at the FDA as the Consumer Representative to the Arthritis Advisory Committee (AAC). These were my first meetings following an almost yearlong process that started with a nomination by Diane Aronson, the Consumer Representative whose term was ending, and culminated with my four year committee appointment. The FDA has many advisory committees consisting of outside experts who provide the FDA with independent opinions and recommendations on applications to market new drugs. As Consumer Representative, my role is to represent the consumer perspective on issues and actions before the FDA AAC.
The first meeting was to review Regeneron Pharmaceuticals’ Arcalyst, also known by its generic name rilonacept, for short-term use to treat gout, a form of arthritis. It was already on the market to treat a rare disease, Cryopyrin-Associated Periodic Syndromes. The second meeting was for Pfizer’s tofacitinib, which was under review for treatment of rheumatoid arthritis. Tofacitinib had quite a bit of press preceding this meeting, mostly focusing on it being a “potential blockbuster, with peak sales of $2 billion to $3 billion a year, if its benefits are deemed to outweigh the risks”.
The most grueling part of preparing for the meetings was reading the materials including clinical trial results from the pharmaceutical companies, who are called the sponsor, and from the FDA, who is called the agency. As I read, I focused on understanding the efficacy and safety of the drugs, and their impact on quality of life. I had many questions, some of which were answered in the documents, and some that I made note of to ask during the meetings.
Regenron’s rilonacept for gout
The May 8 meeting took place at the FDA White Oak Campus, where we had to go through security before going to the meeting room, which was largely empty. The front was roped off for the committee, who sat at a U-shaped table where name tents and folders were waiting for us. The sponsor, Regenron, had rows of chairs on one side, and the agency did on the other side. On the agency side there were people in military uniform, but I never found out who they were. When the meeting started, the process was very formal, with parallels to court although, carrying that analogy further, it wasn’t clear whether we were the judges, the jury, or both.
The meeting was presided over by Lenore M. Buckley, MD, MPH, the committee chair, and Philip Bautista, PharmD, the FDA’s Designated Federal Officer to the AAC. They started by summarizing the meeting agenda and instructing everyone on the protocols for speaking. Each committee member had a microphone with a talk button and yes-no-abstain voting buttons. It was an open meeting, with the public and press sparsely represented, and a live webcast.
The morning consisted of the sponsor’s presentation, followed by the agency’s presentation, each with time at the end for our questions. I was struck by how the sponsor had prepared slides for every anticipated question, all pre-loaded so readily available. I wondered about all the slides we weren’t seeing, and the questions we should be asking but hadn’t. The sponsor also brought experts, who all started by stating their financial involvement with the sponsor and if they benefit from the outcome of the meeting. I was struck by some of the differences between the language used and points made by the sponsor and the agency, including the sponsor’s use of “benefit risk profile” and the agency’s use of “risk benefit profile”.
Following lunch, any member of the public who registered in advance could make a statement. We had some letters in our packets from patients, patient advocates, and physicians that related to rilonacept or, in one case, to men’s health issues, since gout primarily affects men.
Once all sides had been heard, the agency posed their questions to the committee, some for discussion and some for vote. We had further opportunities to ask questions and many of them pertained to the risks. Once votes were captured for each of the three votes, the tally of the votes was displayed and then a table of how individuals voted. The chair asked every panelist to state their name, how they voted, and the reason. The stated reasons seemed to be the primary sound bites captured by the press, especially for the final vote, if the efficacy and safety data supported approval of rilonacept. The committee voted unanimously against approval; I later learned that unanimous votes are rare.
Pfizer’s tofacitinib for rheumatoid arthritis
The second meeting, on May 9, was very different from the first, starting with longer security lines when we arrived in the morning. It was an open meeting with a live webcast again, but this time the auditorium was packed, with a row of press and more patients and patient advocates, including one who I knew from Twitter, Kelly Young. There was a large contingent from Pfizer. One my fellow panelists had told me to expect far more people than the prior day because our vote has much greater financial impact, since this was potentially a blockbuster drug with projected sales of $2 billion to $3 billion a year.
The agenda was similar to the previous meeting. Pfizer presented and, like Regeneron, brought outside experts. Pfizer had many slides in addition to those used in their presentation to answer our questions. Clearly a lot of effort went into anticipating our questions, preparing slides, and indexing them to be able to locate them quickly in response to a question.
I was more confident asking questions than I had been at the first meeting because I better understood the process. I asked Pfizer to elaborate on the safety profile of the longer term clinical trial data regarding the two dosing options, 5 mg and 10 mg, evaluated in the clinical trials. I also asked them if they had plans for patient education and they showed a slide about Dear Doctor and Pharmacist letters which did not answer my question. There was some additional discussion about the efficacy and safety of smaller doses.
The final vote was 8-2 in favor. Many who voted yes urged further research about some of its side effects, concerns that largely didn’t make the headlines. The New York Times accurately reported that we “urged the Food and Drug Administration to require rigorous follow-up studies.” Like the previous meeting, the final vote was only a recommendation to the FDA; as stated in the New York Times, “the agency, which is scheduled to decide on approval by August, usually — but not always — follows the advice of advisory committees.”
A public process for patient safety
The meetings were fascinating and I appreciated the public nature of the process, including making all materials available to the public before the meeting, opening it to the public in person and through streaming, and providing time for people like Jan Wyatt, RN, PhD to speak. I saw the meetings as a milestone in a long chain of events that started with years of research and clinical trials. The meetings were not the end since the FDA needs to make decisions based on the AAC recommendations and then work with the sponsors on their next steps to further ensure efficacy and safety.
I am honored to be part of this committee. Most of all, I have the deepest respect for the professionalism and knowledge of my fellow committee members, the agency, the sponsors, and the public who participated. Together I believe we have the shared goals of bringing new treatments to patients without compromising safety.