Published Studies
Year | Publication | Categories |
---|---|---|
2023 |
Results from the COMPARE Study – How Do Different Medications Impact IBD Patients?
Summary When IBD patients start taking a new medication, it can be hard to know if it will finally be the medication to help achieve remission, or if the side effects will impact sleep, social life, and ability to work. Over 400 IBD Partners participants took part in the COMPARE study to compare the effects of Entyvio vs. Stelara for Crohn's disease and Entyvio vs. Xeljanz for ulcerative colitis. Our patient partners identified fatigue and pain as outcomes of particular interest for this research to focus on. Keywords COMPARE; Entyvio; Stelara; Xeljanz; vedolizumab; ustekinumab; tofacitinib; patient-reported outcomes; pain; fatigue; comparative effectiveness; Crohn s disease; ulcerative colitis; |
Medications |
2021 |
A Randomized Trial Comparing the Specific Carbohydrate Diet to a Mediterranean Diet in Adults with Crohn's Disease
Summary Researchers compared the effectiveness of a Mediterranean style diet to the Specific Carbohydrate Diet in nearly 200 Crohn's disease patients with mild-to-moderate symptoms on stable doses of medications. With both diets, nearly half of the patients experienced resolution of their symptoms. After six weeks, 43.5% of patients following a Mediterranean style diet and 46.5% of patients following the Specific Carbohydrate Diet achieved symptomatic remission. Full Scientific Manuscript Keywords scd; specific carbohydrate diet; specific carbohydrate; md; mediterranean; mediterranean style diet; mediterranean diet; diet; |
Diet |
2021 |
Pregnancy and Neonatal Outcomes After Fetal Exposure to Biologics and Thiopurines Among Women With Inflammatory Bowel Disease
Summary Researchers included nearly 1500 women with Crohn's disease and ulcerative colitis who became pregnant. To better understand pregnancy outcomes, those on medications like biologics were compared to those not on these medications. Children were followed for the first year of life. Full Scientific Manuscript Keywords Crohn s disease; ulcerative colitis; pregnancy; biologics; medication; |
women's health, Medications |
2020 |
Project PREVENT: A Randomized Controlled Trial of Preventive Interventions in Patients With Inflammatory Bowel Disease
Summary Patients with inflammatory bowel disease (IBD) are at increased risk of infections, bone fractures and skin cancers. Preventive health educational messages delivered to patients may reduce the risks of these complications. With patient input, we developed video messages and tested their impact compared to text-based messages. 1056 IBD Partners participants received either video or text-based health reminder messages. The study investigated reminder messages for influenza vaccine, pneumonia vaccine, skin cancer screening, bone health and shingles vaccine. This study found that video and text-based messages for all five topics had a similar impact on intent to get needed care. For the main outcome of influenza vaccine, 57% had received a flu vaccine prior to the preventive health messages, while 73% reported they intended to get a flu vaccine after the intervention. Further studies are measuring whether people followed up to get the needed care. Full Scientific Abstract Keywords Prevent; Flu; Shingles; Bone health; Pneumonia; Skin cancer; |
Alternative Therapies, Research Methods |
2020 |
Association Between Vulvovaginal Discomfort and Activity of Inflammatory Bowel Diseases
Summary Inflammatory bowel diseases (IBD) affect 200-400 people per 100,000 in the United States, about half of whom are women. Our goal was to research how common it is for women with IBD to experience vulvovaginal symptoms. For this study, we recruited women more than 18 years old with IBD (1250) who agreed to complete an online survey that asks questions about the presence and severity of vulvar or vaginal itch, burn, or irritation, vaginal discharge or dryness, and vulvovaginal pain. The survey collected information on background information and a history of their IBD activity history. Women with and withou t symptoms were compared for analyses. For the results, we found a total of 512 women reported at least 1 moderate-severe vulvovaginal symptom. All vulvovaginal symptoms except vaginal dryness were more common in women with active IBD and vulvovaginal discomfort frequently or always decreased interest in sex or ability to have sex. In conclusion, we found that women with more active IBD have increased prevalence of vulvovaginal discomfort, compared to women in remission. These symptoms affect sexual health. Full Scientific Manuscript Keywords Crohn s Disease; Ulcerative Colitis; Vaginitis; Female Patient; |
Health Maintenance |
2019 |
Impact of Obesity on Disease Activity andPatient-Reported Outcomes Measurement InformationSystem (PROMIS) in Inflammatory Bowel Diseases
Summary The rate of diagnoses has increased for both obesity and IBD, and some research suggests that obesity may play a part in the development of IBD. About 15-40% of patients with IBD are obese, which is defined as having a body mass index (BMI) of 30 or higher. However, there has been little research on how obesity might affect outcomes in patients with IBD. In this study of nearly 7300 patients with IBD, we found that about one in 5 patients with IBD were obese. Obese patients were more likely to have active symptoms related to IBD, as compared to patients with normal BMI. Over a period of 12-18 months, we obs erved that obese patients with active disease were significantly less likely to achieve remission. Similarly, among patients in remission at baseline, obese patients were 2-3 times more likely to relapse on follow-up, as compared to patients with normal BMI. Obese patients with IBD were more likely to have anxiety, depression, fatigue, and experience pain. They were also less satisfied with their ability to participate in social roles. These effects were seen in patients with both ulcerative colitis and Crohn's disease. Future studies to find out whether treating obesity may improve outcomes in patients with IBD are needed. Full Scientific Manuscript Keywords Obesity, promis, disease activity; |
Lifestyle |
2019 |
A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn s Disease Flares
Summary Diet may be an important factor in the development and progression of IBD. A previous study demonstrated that patients with ulcerative colitis were more likely to flare with increased consumption of red and processed meats. We sought to examine whether increased consumption of red and processed meats was associated with Crohn's disease (CD) flares. To do this, adults with CD were recruited from IBD Partners. Patients who were in remission were randomly assigned to groups that consumed a minimum of 2 servings/week of red or processed meat (118 patients) or not more than 1 serving per month (96 patients) for 49 weeks. The primar y outcome was relapse of CD, defined as increase in short Crohn's Disease Activity Index or a need for surgery or a need for new medication. During the trial, patients in the high-meat group reported compliance with eating 2 or more servings of red or processed meat during 98.5% of weeks compared to 18.8% of weeks for the low-meat group. In an analysis of data from the FACES trial, we found that among patients with CD in remission, amount of red and processed meat consumption was not associated with risk of flare. Full Scientific Manuscript Keywords diet; red meat; processed meat; Crohn's disease; CD; Flares; |
Lifestyle, Health Maintenance |
2019 |
A Novel Patient-Reported Outcome-Based Evaluation (PROBE) of Quality of Life in Patients With Inflammatory Bowel Disease
Summary In this study, researchers were interested in creating a new, shorter survey to measure health related quality of life (HRQOL) in patients with IBD. To do this, they came up with new patient-reported survey questions and compared them to questions already being used. They were able to create a shorter, 6-question survey known as the PROBE that measures HRQOL just as well as longer instruments. The researchers believe that this shorter survey will make it easier to assess HRQOL among patients with Crohn's disease and ulcerative colitis when providers treat patients in the clinic, and when IBD is eva luated in future research studies. Full Scientific Manuscript Keywords quality of life; |
Lifestyle |
2018 |
Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Subjects With Inflammatory Bowel Diseases
Summary Patient reported outcomes (PROs) are important measures of how well treatments work in inflammatory bowel disease (IBD). PROs are symptoms reported directly by patients, rather than tests like colonoscopies or blood work. The PRO Measurement Information System (PROMIS) is a scale for measuring PROs for physical, mental, and social health. A gastrointestinal (GI) PROMIS scale was recently developed based on responses from people across the United States. The GI PROMIS scale includes questions about eight common GI symptoms: gas, reflux, diarrhea, soilage, constipation, belly pain, nausea and vomiting, and difficulty swallowing. We studied these questions in 2,378 people with Crohn's disease (CD) and 1,455 people with ulcerative colitis (UC) in CCFA Partners. About half of the participants reported being in remission. Compared to participants in remission, those with active CD reported worse symptoms on the GI-PROMIS scale for all symptoms. The same was true for participants with active UC with the exception of difficulty swallowing. Participants with worse quality of life reported worse symptoms on the GI-PROMIS scale for all symptoms. Participants with more diarrhea, belly pain, and gas reported poorer mental and social PROs. In summary, participants who reported worse GI-PROMIS symptoms also reported worse qualify of life, disease activity, and mental and social outcomes. These results suggest that the GI-PROMIS scales could be an important way to measure symptoms in the future. Full Scientific Manuscript Keywords patient reported outcomes; IBD; quality of life; GI-PROMIS; psychosocial symptoms; |
Research Methods |
2017 |
Symptom Clusters in Adults with Inflammatory Bowel Disease
Summary Symptoms (pain, fatigue, sleep disturbance, depression, and anxiety) are common among people with Inflammatory Bowel Disease (IBD). We know people do not experience only one symptom and symptoms may occur is clusters. Symptom clusters are two or more symptoms that occur together and are related. Understanding how symptoms cluster is needed so that we can develop methods that decrease multiple symptoms in IBD. The purpose of this study was to (a) describe how symptoms cluster in IBD, and (b) to describe the relationship between demographic and clinical factors and symptom cluster membership. Full Scientific Manuscript Keywords symptom clusters; pain; fatigue; sleep disturbance; depression; anxiety; low symptom cluster; high symptom cluster; Crohn s disease; CD; ulcerative colitis; UC ; |
Study Updates, Medications, Treatment |
2017 |
Obesity Is Associated with Worse Disease Activity in Patients with Inflammatory Bowel Diseases: an Internet Based Cohort Study
Summary More than 1/3 of adults in the US are obese and the rates of obesity are increasing. However, relatively little is known about the prevalence of obesity in patients with inflammatory bowel disease (IBD) or the impact of obesity on IBD disease activity. In this study, we reviewed patients in the CCFA Partners database to better understand these issues. We found that approximately 30% of IBD patients were overweight and an additional 20% were obese. Patients who were overweight or obese were less likely to have their IBD in remission at baseline. We also found that patients who were obese (but not overweight patients) were more likely to have a relapse of their IBD within 6-12 months compared to normal weight patients. In summary, obesity appears to be relatively common amongst patients with IBD and may be a risk factor for worsened disease. Full Scientific Abstract Keywords comorbidity; obese; obesity; overweight; nutrition; patient reported outcomes; |
Study Updates, Lifestyle |
2017 |
Prevalence and impact of inflammatory bowel disease-irritable bowel syndrome (IBD-IBS) on patient reported outcomes in CCFA Partners
Summary People with inflammatory bowel disease, or IBD, commonly experience diarrhea and abdominal pain. These symptoms are often related to inflammation associated with IBD. Sometimes these symptoms are related to both IBD and irritable bowel syndrome, or IBS. IBS is sensitivity of the intestine without inflammation. Patients with IBD who are diagnosed with IBS may experience changes in their care and well-being. We looked at the rate of IBD-IBS diagnosis in the CCFA Partners network. We also looked at how a diagnosis of IBD-IBS impacts outcomes, such as ability to perform normal daily activities, and use of specific medications. A total of 6309 patients were included, of these, 20% reported being diagnosed with IBS after their IBD diagnosis. Patients with both an IBD and IBS diagnosis had higher rates of narcotic use compared to patients with an IBD diagnosis alone. An IBS diagnosis was associated with anxiety, depression, fatigue, poor sleep quality, pain interference, and decreased social satisfaction. Appropriate diagnosis, treatment, and counseling may help improve outcomes experienced by IBD-IBS patients and reduce narcotic use in this group. Full Scientific Manuscript Keywords community; population; comorbidity; IBD-IBS; inflammatory bowel disease-irritable bowel syndrome; irritable bowel disease; IBS; |
Medications, Lifestyle, Mental Health |
2016 |
The impact of ostomy on quality of life and functional status of Crohn's disease patients within CCFA Partners
Summary Patients with Crohn's disease, or CD, may require surgery during the course of their disease. This can result in the need to create a permanent or a temporary ostomy. Ostomy is the term used to describe the surgically created connection between the intestine and the abdominal wall. It allows for the evacuation of the fecal matter through the abdominal wall. The potential need for an ostomy is a major concern for many patients with inflammatory bowel disease as it may impact their daily function and quality of life. Within the CCFA Partners network, we evaluated the characteristics of CD patients who had an ostomy for at least 6 months. We also looked at how ostomy impacts their daily function and quality of life. A total of 4733 patients were included, of these, 402 reported an ostomy for at least 6 months. Patients with ostomy were more likely to be in clinical remission compared to those with no ostomy. Also, only half the patients with ostomy were receiving specific IBD therapies. Having an ostomy did not impact the quality of life or sexual function (interest and satisfaction) of CD patients. Additionally, there was no association between having an ostomy and anxiety, depression, or sleep disturbances. However, having an ostomy was associated with increased pain interference, fatigue and lower social satisfaction. It was also associated with higher rated of narcotic use. Appropriate counseling before and after surgery can help improving social satisfaction for patients with ostomy. Further studies are needed to determine the nature of pain and fatigue in this population. Full Scientific Manuscript Keywords ostomy; quality of life; social health; Crohn's disease; crohn's; CD; |
Lifestyle, Mental Health |
2016 |
Evaluation of Gastrointestinal Patient Reported Outcomes Measurement Information System (GI-PROMIS) Symptom Scales in Patients with Crohn's Disease in CCFA Partners
Summary Patient reported outcomes (PROs) are important measures of how well treatment works in Crohn's disease (CD). PROs are symptoms reported directly by patients, rather than tests like colonoscopies or blood work. The PRO Measurement Information System (PROMIS) is a new scale for measuring PROs for physical, mental and social health. The results can be compared to those from people that don't have IBD. A gastrointestinal (GI) PROMIS scale was recently developed. The GI scales were not studied in large numbers of Crohn's patients, but were studied in people all across the United States. We studied these questions in 1839 people with Crohn's disease in CCFA Partners. Most (75%) were women. People with Crohn's disease reported more fatigue, anxiety and pain compared to people without Crohn's disease. People with Crohn's disease reported less reflux, problems swallowing and constipation than people without Crohn's disease. Other GI symptoms for people with Crohn's disease were similar to those reported by people without Crohn's disease. Compared to people in remission, people with active CD reported worse symptoms on the GI-PROMIS scales for all symptoms except problems swallowing and constipation. Those with a worse quality of life, as measured by the Short IBD Questionnaire (SIBDQ), reported worse symptoms on the GI-PROMIS scales all symptoms. People who reported more nausea, diarrhea, gas/bloat and abdominal pain reported more psychosocial symptoms on the PROMIS scales. In summary, those with worse symptoms on the GI-PROMIS scales scored worse disease activity scales, quality of life scales and more symptoms of depression and anxiety. These scales could be important ways to measure symptoms in the future. Full Scientific Abstract Keywords Patient reported outcomes; PROs; PROMIS; survey instruments; Crohn s disease; CD; |
Research Methods, Health Maintenance |
2016 |
Variation in Care of Inflammatory Bowel Diseases Patients in CCFA Partners:Role of Gastroenterologist Practice Setting in Disease Outcomes and QualityProcess Measures
Summary Variation in care of patients with Crohn's disease (CD) and ulcerative colitis (UC) has been used as a marker for quality differences. We studied whether important aspects of IBD patients' care in CCFA Partners varied based on where their GI doctor was in practice. We compared patients who saw an academic (university) GI physician, a private practice GI physician, or other GI physician (such as a Veteran's Affairs physician). The study included about 12,000 IBD patients. Almost 95% reported visiting a GI provider at least once a year: about 74% saw a private practice physician, 15% academic, and 11% other. Those patients with CD seen by academic physicians were younger, has completed higher education, used less mesalamine medications, and used more biologics and immunomodulators. They were more likely to be in remission, were more likely to get a flu shot, smoked less, and were less likely to be on steroids when compared to private or other physicians. Patients with UC seen by academic providers were younger, had more hospitalizations and surgery, with greater biologic and immunomodulator use. There was no difference in steroid use, and no differences in any of the other measures like remission rates, flu shot, quality of life. In summary, there was much more variation in CD care as compared to UC care, with improved outcomes for CD patients seen by academic providers. Studying why this is the case, could help us to improve the quality of care delivered to all IBD patients. Full Scientific Manuscript Keywords healthcare setting; quality of care; remission; gastroenterologist; quality of life; QOL; medications; Crohn s disease; Crohn s; CD; ulcerative colitis; UC; colitis; |
Health Maintenance, Environment, Medications |
2016 |
Menopause and Hormone Replacement Therapy in Women with Inflammatory Bowel Diseases in CCFA Partners
Summary Women with inflammatory bowel disease, or IBD, frequently experience changes in abdominal symptoms (e.g. bowel frequency and pain) in relation to the different stages of the menstrual cycle. This may be related to the hormonal changes during the various stages of the cycle. Menopause is the state when the menstrual cycles and associated hormonal fluctuations stop permanently. This can occur naturally in relation to age or can be secondary to surgery or medical therapy that impact the reproductive organs. The impact of menopause on disease activity of patients with IBD is unknown. We assessed the disease characteristics of menopausal women within the CCFA Partners network. We also evaluated the impact of menopause and hormone replacement therapy, or HRT, on disease activity. A total of 2252 women were included in this study. Of these, 799 indicated that they had gone through menopause. The majority of post-menopausal women reported natural menopause with an average age of 50 in both Crohn's disease and ulcerative colitis patients. About half the post-menopausal women indicated a current or prior use of HRT. The post-menopausal state was associated with increased disease activity in both Crohn's disease and ulcerative colitis patients. This association was more prominent for women at age = 45 compared to those older than 45 years. Interestingly, the use of HRT did not impact disease activity at any age. Those findings suggest that the cessation of hormonal fluctuation in post-menopausal women as well as the age play role in predicting disease activity in women with IBD. Full Scientific Abstract Keywords female; feminine; women s health; women; menopause; hormone; hormonal influence; hormonal fluctuation; Hormone Replacement Therapy; HRT; |
Lifestyle, Mental Health |
2013 |
Behavioral Strategies to Improve Cohort Retention within CCFA Partners
Summary Earlier studies have shown that people who participate in surveys (such as CCFA Partners) may respond better to survey requests if these have a time limit (such as telling participants that surveys need to be done in 72 hours). This is called "scarcity." Other ways to improve survey response include messages targeting: paying it forward (that what you are doing will help people in the future), guilt, altruism (helping others), and self-serving (helping yourself). Our goal was to see if scarcity or these messages improved response rates within CCFA Partners. The scarcity group received a 'warning' email informing them that they will be sent a survey link the next day, and that they will have 72 hours to complete the survey. The control group received no warning email. We also tested the four different messages described above and a "control" message that just informed patients that it was time for their survey. We sent emails to a total of 8697 people within CCFA Partners asking them to complete their follow-up surveys. Of these, 2965 started their follow up survey. There was no difference between those in the 'scarcity group' as compared to control group. Scarcity was, however, more effective in the >50 age group. Of the messages, guilt resulted in a significantly higher response rate, while the other messages were no different than control. In summary, behavioral interventions applied to an internet-based IBD cohort have little benefit in improving response rates. Guilt had the strongest effect. The reasons that the other messages did not work may be that these interventions don't apply in an IBD population, that e-mail messages are not as effective, or that members of CCFA Partners are already very motivated to fill out surveys. Full Scientific Abstract Keywords cohort; response; retention; community; population; behavioral strategies; behavior; |
Research Methods, Study Updates |