Key Points
- The research team has been working on understanding what people who have rheumatoid arthritis (RA) care about when it comes to their symptoms. Dr. Bingham and Dr. Bartlett have lead an international research project to find what patients with RA around the world felt was important to ask.
- People living with RA noted that their condition did a lot more than cause them pain and worse physical function. These had been the only things that rheumatologists were asking about routinely and following to see if a drug was working.
- RA patients said that fatigue, sleep, mood, and stiffness were all important to them. They also said that asking them about how arthritis impacts their ability to do activities that mattered to them was very important.
- After finding out symptoms and areas of interest patients felt were important, there needed to be a way to evaluate them.
- In 2004, the National Institutes of Health (NIH) created the Patient-Reported Outcomes Measurement Information System (PROMIS). This system uses the most advanced measurement science to provide questionnaires that can be given on a computer or on paper forms. PROMIS covers a large spectrum of symptoms and impacts related to physical health, emotions and thinking, and social health.
- Using the PROMIS system, the Hopkins research team began a research study that took place over two years to determine if PROMIS measures could be easily used in clinic, what they could tell about the types of symptoms RA patients were having, and how doctors and patients could use this information.
Planning the Study
Including patient-reported outcomes (PROs) to measure how a patient is doing is not new to rheumatology. A “Core Set” of measures has been developed for following RA patients in clinical trials and in the office. These include a patient evaluation of how they are doing (called the patient global assessment), a question about pain, and a questionnaire asking about physical function.
To better understand what patients with RA considered important to them when it came to their health care, Dr. Bingham and Dr. Bartlett began a large research program that started in 2006. This was an international study that involved patients as research partners to plan and analyze the study results. That study included interviews and focus groups with patients and a large survey given to patients, doctors, and researchers asking them what they thought were the most important things to know about RA. These studies showed that people living with RA thought that there was more to how their disease affected them, beyond the pain and physical function that doctors were asking them about. While these areas were important, patients also wanted their doctors to ask them and evaluate their fatigue, sleep, mood, stiffness, and the impact arthritis had on their ability to do activities that mattered to them.
In 2004, the National Institute of Health began creating the Patient Reported Outcomes Measurement Information System (PROMIS). PROMIS was developed using the most advanced type of measurement science to create a large collection of questions that covered many different aspects of quality of life. These included things like physical symptoms (pain, fatigue, sleep, physical function), emotions and cognitive areas (like mood and depression, anxiety, and thinking), and aspects of social health such as how people are able to participate in activities that matter to them and the roles they play in life.
One of the unique things about PROMIS is that it can accurately identify where someone is along an entire spectrum of a symptom from the very best to the very worst. A PROMIS score also shows where someone’s symptoms are compared to the “normal” US population, somewhat like a symptom “thermometer” or “ruler”.
PROMIS can be given as paper questionnaires but another one of the unique things about PROMIS is that it can be given using a computer with a special algorithm. This is called a Computer Adaptive Test or CAT. The CAT does not ask the same questions for everybody like a paper form. The computer asks the next question based on the prior question, choosing from the hundreds of questions to find out exactly where someone is along the symptom “ruler”.
PROMIS can then provide a readout that shows the current level of symptoms compared to the average for the population in the United States.
With the PCORI pilot study , Dr. Bingham, Dr. Bartlett, and the research team created a PROMIS tool to capture those symptoms and impacts that people with RA felt were important. The objective was to use PROMIS in a clinical setting, when patients were seeing their doctors for a usual visit, to get a better picture of how people with RA were living with their disease. Before the pilot study, PROMIS had been used mostly for research but had not been widely tested in a clinic in this way. A few key goals for the PCORI pilot study:
- Learn if this system would take too much of the patients’ and providers’ time, and if patients with arthritis would have any trouble using the computer to answer questions.
- Learn what doctors and patients thought about these PROs to see how this new information would be used. And also to find out if this would change communication between patients and doctors and factor into how decisions were made about their treatment.
- See how rheumatoid arthritis patients would compare with the population regarding a range of symptoms and disease impacts using the PROMIS measures.
Before any research could begin, a protocol for the study was developed and sent to the Johns Hopkins Institutional Review Board (IRB) for approval. The protocol is a document that describes the study in its entirety: the purpose of the study, how the study is organized, who can participate, how researchers will conduct the study, risks and benefits for participants, and how the data will be analyzed.
There were several purposes for the PCORI study. First, researchers wanted to know how easy it was to collect additional PRO data in a clinical setting. Next, they wanted to determine the impact this information had on healthcare decisions such as:
- Identifying new problems or symptoms
- Changing RA treatment
- Patient Satisfaction
- Patient-Doctor communication
Finally, they wanted to look at how people with RA scored on PROMIS measures compared to the US population to guide doctors and patients in using these in other settings.
For this study, any patient diagnosed by their doctor as having rheumatoid arthritis, between the ages of 18-85, and seen at the Johns Hopkins Rheumatology clinic could participate.
Research coordinators talked to patients about being a part of the study. They explained to them what they would be asked to do and answered their questions about the study.
Conducting the Research
When patients came for their visit, they would check in at the front desk. They were asked to come a few minutes earlier than usual to complete the questionnaires. The coordinator would greet the patient and give them an electronic tablet computer. The patient would then complete questionnaires on the tablet while they waited for the doctor.
After the questionnaire was completed, the coordinator printed out the results and put this in the chart for the doctor to review with the patient.
ACKNOWLEDGEMENTS AND DISCLAIMERS: The research project described was funded through a Pilot Project Award (IP2-PI0000737) from the Patient Centered Outcomes Research Institute (PCORI) awarded to Dr. Clifton Bingham. Funding to enable the development of material concerning this project was provided in part through a Eugene Washington PCORI Engagement Award (EAIN-1988). This work described has also been supported through the Rheumatic Diseases Research Core Center funded by the National Institutes of Health (NIH) and the National Institute of Arthritis, Musculoskeletal, and Skin Diseases (NIAMS) (P30-AR053503), the Ira Fine Discovery Fund, the Don and Dorothy Stabler Foundation, and the Camille Julia Morgan Arthritis Research and Education Fund. All statements on this website, including its findings and conclusions, are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors, or Methodology Committee, or of NIAMS or NIH. We thank the patients, staff, and physicians for their participation in this study as well as our external stakeholders and advisors. Special thanks to CreakyJoints® (www.CreakyJoints.org) for their time and support for this project and the engagement of an activated online community of people living with arthritis.
