Background.-Migraine is a disabling primary headache disorder often associated with triggers. Diet-related triggers are a common cause of migraine and certain diets have been reported to decrease the frequency of migraine attacks if dietary triggers or patterns are adjusted. Objective.-The systematic literature review was conducted to qualitatively summarize evidence from the published literature regarding the role of diet patterns, diet-related triggers, and diet interventions in people with migraine. Methods.-A literature search was carried out on diet patterns, diet-related triggers, and diet interventions used to treat and/or prevent migraine attacks, using an a priori protocol. MEDLINE and EMBASE databases were searched to identify studies assessing the effect of diet, food, and nutrition in people with migraine aged ≥18 years. Only primary literature sources (randomized controlled trials or observational studies) were included and searches were conducted from January 2000 to March 2019. The NICE checklist was used to assess the quality of the included studies of randomized controlled trials and the Downs and Black checklist was used for the assessment of observational studies. Results.-A total of 43 studies were included in this review, of which 11 assessed diet patterns, 12 assessed diet interventions, and 20 assessed diet-related triggers. The overall quality of evidence was low, as most of the (68%) studies assessing diet patterns and diet-related triggers were cross-sectional studies or patient surveys. The studies regarding diet interventions assessed a variety of diets, such as ketogenic diet, elimination diets, and low-fat diets. Alcohol and caffeine uses were the most common diet patterns and diet-related triggers associated with increased frequency of migraine attacks. Most of the diet interventions, such as low-fat and elimination diets, were related to a decrease in the frequency of migraine attacks. Conclusions.-There is limited high-quality randomized controlled trial data on diet patterns or diet-related triggers. A few small randomized controlled trials have assessed diet interventions in preventing migraine attacks without strong results. Although many patients already reported avoiding personal diet-related triggers in their migraine management, high-quality research is needed to confirm the effect of diet in people with migraine.

Background Migraine is a chronic, disabling neurological disease characterized by moderate-to-severe headache pain with other symptoms, including nausea, vomiting, and photophobia. Triptans, while generally effective, are insufficiently efficacious in 30–40% of patients and poorly tolerated by or contraindicated in others. We assessed the impact of insufficient response to triptans on health-related quality of life (HRQoL) and work productivity in patients currently receiving any prescribed triptan formulation as their only acute migraine medication. Methods Data were from the 2017 Adelphi Migraine Disease Specific Programme, a cross-sectional survey of primary care physicians, neurologists, and headache specialists and their consulting patients with migraine in the USA, France, Germany, Italy, Spain, and UK. Triptan insufficient responders (TIRs) achieved freedom from headache pain within 2 h of acute treatment in ≤3/5 migraine attacks; triptan responders (TRs) achieved pain freedom within 2 h in ≥4/5 attacks. Multivariable general linear model examined differences between TIRs and TRs in HRQoL and work productivity. Logistic regression identified factors associated with insufficient response to triptans. Results The study included 1413 triptan-treated patients (TIRs: n = 483, 34.2%; TRs: n = 930, 65.8%). TIRs were more likely to be female (76% vs. 70% for TIRs vs TRs, respectively; p = 0.011), older (mean age 42.6 vs. 40.5 years; p = 0.003), and had more headache days/month (7.0 vs. 4.4; p < 0.001). TIRs had significantly more disability, with higher Migraine Disability Scores (MIDAS; 13.2 vs. 7.7; p < 0.001), lower Migraine-specific Quality of Life scores, indicating greater impact (Role Function Restrictive: 62.4 vs. 74.5; Role Function Preventive: 70.0 vs. 82.2; Emotional Function: 67.7 vs. 82.1; all p < 0.001), and lower EQ5D utility scores (0.84 vs. 0.91; p = 0.001). Work productivity and activity were impaired (absenteeism, 8.6% vs. 5.1% for TIRs vs. TRs; presenteeism, 34.3% vs. 21.0%; work impairment, 37.1% vs. 23.3%; overall activity impairment, 39.8% vs. 25.3%; all p < 0.05). Conclusion HRQoL and work productivity were significantly impacted in TIRs versus TRs in this real-world analysis of patients with migraine acutely treated with triptans, highlighting the need for more effective treatments for patients with an insufficient triptan response. Further research is needed to establish causal relationships between insufficient response and these outcomes.

Background Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged exposure to dopamine receptor blocking agents such as antipsychotics. With the expanding use of antipsychotics, research is needed to better understand patient perspectives of TD, which clinical assessments may fail to capture. Social media listening (SML), which is recognized by the US FDA as a method that can advance ongoing efforts for more patient-focused drug development, has been used to understand patient experiences in other disease states. This is the first study to use SML analysis of unsolicited patient and caregiver insights to help clinicians understand how patients describe their symptoms, the emotional distress associated with TD, and the impact on caregivers. Methods In this pilot study, a comprehensive search was performed for publicly available, English-language, online content posted between March 2017 and November 2019 on social media platforms, blogs, and forums. An analytics platform (NetBase™) identified posts containing patient or caregiver experiences of assumed TD using predefined search terms. All posts were manually curated and reviewed to ensure quality and validity of the post and to further classify key symptoms, sentiments, and themes. Results A total of 261 posts from patients/caregivers (“patient insights”) were identified using predefined search terms; 107 posts were used for these analyses. Posts were primarily from forums (47%) and Twitter (33%). Analysis of the most common sentiment-related terms (e.g. “feel” [n = 31], “worse” [n = 17], “symptom” [n = 14], “better” [n = 12]) indicated that 64% were negative, 33% were neutral, and 3% were positive. Theme analysis revealed that patients often felt angry about having TD from a medication used to treat a different condition. In addition, patients felt insecure, including feeling unaccepted by society and fear of being judged by others. Conclusion Although this study was limited by inherent methodological constraints (e.g., small sample size, reliance on patient self-report), the perspectives generated from analyzing social media may help convey the unmet needs of patients with TD. This analysis indicated that movement-related symptoms are the most common patient concern, resulting in strong feelings of anger and insecurity.

Background Disease burden, a definition of remission, and symptoms that drive treatment seeking were explored in a Crohn’s disease (CD) population. Methods A qualitative semistructured interview guide was developed, informed by published literature. Clinicians identified adolescents and adult patients with CD. Face-to-face interviews were audio-recorded and transcribed. Two rounds of interviews were conducted with patients. Transcripts were analyzed using thematic methods facilitated by ATLAS.ti. Results Twenty-four patients participated in the first round of interviews (n = 16 adults, mean age 50.3 years; n = 8 adolescents, mean age 15.6 years). Abdominal pain (n = 24), urgent bowel movements (n = 24), diarrhea (n = 23), and frequent bowel movements (n = 21) were the most frequently reported symptoms. CD affected patients’ physical functioning, daily activities, emotional wellbeing, social functioning, work/education, and relationships. No major difference in disease burden was observed between adolescents and adults. Twenty-three patients (96%) reported they would seek or had sought medical treatment for at least one symptom including abdominal pain (n = 19), diarrhea (n = 12), and blood in stools/rectal bleeding (n = 9). On a 0–10 scale (0 = no symptom and 10 = symptom at its worst possible), most patients (87%, 20/23) answered they would seek/had sought treatment when the symptom’s severity was at least 7. In the second round of interviews (n = 6 adults, mean age 51.5 years), 5/6 patients described that they did not require a complete absence of abdominal pain or loose/watery stools to consider their CD to be in remission. Conclusions CD is associated with substantial disease burden. Worsening of some symptoms drives treatment seeking. To some patients, remission is not defined as a complete absence of symptoms.

Objectives: To assess general public perceptions (aged 50 and above) of colorectal screening value, and knowledge of options available. Methods: A random US sample of adults, aged 50 and older with health insurance, were invited to participate in an online survey administered by Qualtrics® in October 2018. Instrument was developed with input from one public health faculty and three pharmacists with expertise in gastroenterology and health outcomes. Results: 1,732 US adults (Mean=62.1yrs, SD=7.8), predominantly female (73%), white (77%), acquiring their health insurance through their employers/Medicare (79%), with at least some college education (70%), and average household incomes completed surveys. Respondents stated 92% had a usual doctor they frequented: colonoscopy screening was recommended by only 75% of physicians, 30% did not have a colonoscopy within 6 months of their providers' recommendation, and 37% have never had colorectal screening. Almost all respondents (94%) knew why colorectal screening was recommended. Respondents avoided colonoscopy because they considered: preparation disagreeable (96%), fear perforation (96%), fear cancer 96%), anesthesia (95%), modesty (95%), didn't feel they are at risk (no family history/no symptoms 91%), fear pain/discomfort (88%), cost (15%), 'didn't want it', 'inconvenience,' and 'procrastination.' Only 35% of respondents were advised of alternatives to colonoscopy: DNA stool test (Cologuard ® 23%), gFOBT/iFOBT/FIT (14%), pill camera colonoscopy (PILLCam TM ,2%), CT colonoscopy (3%), flexible sigmoidoscopy (4%), double contrast barium enema (2%) and Septin9 DNA blood test (Epi proColon ® ,1%). Conclusions: Respondents avoid colonoscopies, even though they understand why this test is performed. Most respondents are unaware of alternatives available for colorectal screening without the inconvenience, modesty concerns, or fear associated with colonoscopies. Given the variety of less invasive options now available for colorectal screening, patients' attitudes and concerns towards screening must be considered by providers in a shared decision making model, in order to successfully engage patients in colon cancer screening.

Background People with classic congenital adrenal hyperplasia (CAH) often require supraphysiologic doses of glucocorticoids (e.g., hydrocortisone, dexamethasone) to treat cortisol deficiency and excess androgen production. Healthcare providers and patients continually try to balance androgen control with side effects from supraphysiologic glucocorticoids. This study aimed to understand the preferences of adults with classic CAH regarding benefits of a potential new adjunctive medication that may provide better androgen control and allow for lower glucocorticoid doses. Methods Discrete choice experiment (DCE) methodology was used to calculate the relative stated preferences for the additional therapy's hypothetical benefits (attributes). Seven attributes were developed for the DCE after review of relevant data and qualitative literature, interviews with eight adults with classic CAH and input from two endocrinologists. The online DCE survey was piloted via interviews with three adults with classic CAH and a soft launch, which confirmed survey content and functioning. Preference data and subgroup differences were analyzed using conditional logit and scale assessment modelling, respectively. Results US adults with classic CAH (N=118, 75% female, age 19–69) valued avoidance of glucocorticoid-induced weight gain by twice the magnitude of other treatment attributes (all coefficients p&lt;0.001 compared to baseline levels of no avoidance/decrease/improvement): complete avoidance of weight gain from glucocorticoids (1.109); moderate decrease in risk of developing health conditions from long-term glucocorticoids: type 2 diabetes (0.540), osteopenia, osteoporosis, fractures (0.521) and cardiovascular disease (0.502); moderate improvement in: fatigue (0.439), fertility (0.437) and excessive body hair (females only) and acne (0.410). Avoidance of glucocorticoid-induced weight gain remained the most preferred attribute across all subgroup analyses. Avoidance of glucocorticoid-induced weight gain was relatively much more important to females (n=89) than males (n=28) and participants with a body mass index ≥30 (n=70) than &lt;30 (n=48). Improvement in fertility was more important to males than females, was valued by participants aged 18–45 (n=82) but was not a significant preference in participants &gt;45 (n=36) and was relatively more important to participants with fertility problems (n=31) than without (n=87). Improvement in hirsutism and acne was highly valued by participants with excessive hair growth (n=38) but had the lowest preference among those without (n=80). Improvement in fatigue was a significant preference for participants with energy problems (n=73) but was not significant for those without (n=45). Conclusions The strong and consistent preference for avoiding glucocorticoid-induced weight gain suggests that patients with classic CAH would most value a novel adjunctive therapy that helps mitigate glucocorticoid-induced weight gain. In relation to other potential adjunctive therapy benefits, reduced risk of glucocorticoid-driven side effects may be valued more than improvement in fatigue or androgen-driven adverse events (fertility and hirsutism/acne). However, subgroup analyses indicated that individuals’ characteristics impact their treatment preferences and priorities, after avoidance of glucocorticoid-induced weight gain. Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.

Introduction Classic congenital adrenal hyperplasia (CAH) is a rare autosomal recessive disorder, usually due to a deficiency in the 21-hydroxylase enzyme, that results in impaired cortisol synthesis and excess androgen production. Recommended guidelines for management of CAH include assessment of androgen control by routine clinical investigations and patient examination for treating both disease-related and drug-related symptoms. The objective of this study was to identify treatment patterns in patients with classic CAH with reference to guideline-directed care in the United States (US). Methods A retrospective analysis of real-world data on patients with classic CAH was carried out using claims data between Oct 2012 and July 2020 (8 years) from the EVERSANA open claims database of 290 million US citizens. The initial cohort included patients with two or more CAH-related ICD 9/ICD 10 codes at least 28 days apart, and two or more oral glucocorticoids (GCs) prescribed at least 28 days apart within one year of CAH diagnosis. The final CAH cohort combined unique patients identified from two sub-cohorts based on GC adherence (sensitivity 1: patients with 60% proportion of days covered and sensitivity 2: patients with five or more GC prescriptions from date of diagnosis to end of study period or available data for that patient). Information on demographic and clinical characteristics, comorbidities, prescribed medications (including corticosteroids), procedures, and referrals were analysed. Results The final cohort included 11,765 patients (overall mean age 28.7 years) of which 36.9% (n=4,338) were pediatric (0-17 years of age; mean age 8.4 years) and 63.1% were adults (n=7,427; mean age 40.5 years). The majority of CAH patients (62%; n=7,260) reported hydrocortisone use, with a higher proportion of pediatric patients on hydrocortisone (96%; n=4,158) compared to adults (42%; n=3,102). Other frequently prescribed corticosteroids were prednisone (30% pediatric; 68% adults), fludrocortisone (65% pediatric; 34% adults), dexamethasone (25% pediatric; 50% adults), and methylprednisolone (6% pediatric; 43% adults). Among diagnostic procedures and labs, total testosterone (47% pediatric; 46% adults), thyroid stimulating hormone (29% pediatric; 55% adults), 17-hydroxyprogesterone (62% pediatric; 33% adults), androstenedione (55% pediatric; 20% adults), glycated hemoglobin (18% pediatric; 41% adults) and free thyroxine (23% pediatric; 36% adults) were most common. Furthermore, bone age studies were reported in 19% of pediatric patients (51% of pediatric CAH patient population). Only 44% of adult CAH patients and 34% of pediatric CAH patients visited an endocrinologist or pediatric endocrinologist between Oct 2012 and July 2020. Conclusions In line with guidelines, most pediatric patients received short-acting hydrocortisone. However, a large proportion of patients with classic CAH were not treated by an endocrinologist and did not receive guideline-recommended therapy or laboratory testing or bone age assessments, putting them at risk for poor disease control and GC-related adverse events. Presentation: Saturday, June 11, 2022 1:00 p.m. - 3:00 p.m.

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