Kelly Hollis

Prevalence and demographics of irritable bowel syndrome: results from a large web‐based survey

Background :u2002Irritable bowel syndrome is a common gastrointestinal disorder, and its prevalence and demographics have been evaluated by different methodologies with varying results.

Gastrointestinal side effects in chronic opioid users: results from a population-based survey.

Backgroundu2002 Gastrointestinal side effects are commonly associated with opioid treatment for pain.

EpiPen4Schools pilot survey: Occurrence of anaphylaxis, triggers, and epinephrine administration in a U.S. school setting.

BACKGROUNDnAlthough epinephrine is the treatment of choice for anaphylaxis, it remains underused.nnnOBJECTIVEnThis study was designed to describe anaphylactic events and epinephrine autoinjector (EAI) use in U.S. schools enrolled in the EpiPen4Schools program.nnnMETHODSnThis exploratory, cross-sectional, Web-based survey of 6019 schools that participated in the EpiPen4Schools program assessed anaphylactic events and EAI use at responding schools during the 2013-2014 school year.nnnRESULTSnA total of 919 anaphylactic events were reported in 607 schools. Of the 852 anaphylactic events with data on those who experienced an event, most 88.8% (n = 757) occurred in students, and 21.9% of events (n = 187) occurred in individuals with no known allergies. Of the 851 events with data on EAI use, 74.7% (n = 636) were treated with EAIs and 8.5% (n = 54) received a second epinephrine injection. Of the 204 individuals not treated with an EAI, 77.0% (n = 157) received antihistamines, 12.7% (n = 26) received another treatment, and 8.3% (n = 17) received no treatment. Of the 850 events with data on hospital transport, 79.6% of individuals (n = 677) were transported to the hospital. Common triggers varied seasonally, with food listed most frequently overall (62.5%).nnnCONCLUSIONnMore than one in ten schools that participated in the EpiPen4Schools survey reported an anaphylactic event. Approximately 25% of individuals with anaphylactic events were not treated with EAIs, and 20.4% of patients were not taken to the hospital after an anaphylactic event. Analysis of these data supports the value of stocking EAIs and of providing continuing education regarding the recognition and proper treatment of anaphylaxis for school personnel.

A patient follow‐up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme

In November 2002, alosetron HCl (Lotronex, GlaxoSmithKline Research Triangle Park, NC, USA) was re‐introduced to the US marketplace for women with severe diarrhoea‐predominant irritable bowel syndrome. In support of the re‐introduction, a risk management programme was implemented, which included a patient follow‐up study in which all users of alosetron could participate.

Training and administration of epinephrine auto-injectors for anaphylaxis treatment in US schools: results from the EpiPen4Schools ® pilot survey

Background Anaphylaxis is a serious, potentially life-threatening condition. Adequate preparation for anaphylaxis management is imperative for school personnel. This descriptive pilot study assessed preparedness of US schools to manage anaphylactic reactions. Methods An exploratory, cross-sectional, web-based, pilot survey assessed the occurrence and characteristics of anaphylactic events, as well as training provided to school personnel for the recognition and treatment of anaphylaxis. Eligible US schools were participants in the EpiPen4Schools® program during the 2013–2014 school year. EpiPen4Schools provides EpiPen® (epinephrine injection) Auto-Injectors and training materials to qualifying US schools. Survey data were parsed by US Census Bureau region and state and were evaluated using descriptive statistics. Results Schools from all 50 states and the District of Columbia participated in the survey (N=6,019). Among schools that provided information on anaphylactic events, 11% (607/5,683) reported the occurrence of one or more events, with significant variability in incidence across census regions and among states. A total of 5,613 schools provided information regarding which staff members were trained to recognize the signs and symptoms of anaphylaxis. Thirty-six percent of schools (2,022/5,613) indicated that only the school nurse and select staff were trained in anaphylaxis recognition. The proportion of schools in which most or all school staff received such training differed by region/state (range, 13%–100%). A total of 5,578 schools provided information on which staff were permitted to administer epinephrine. The majority of schools (54%; 3,024/5,578) permitted only the school nurse and select staff to administer epinephrine, although percentages varied by region/state (range, 4%–100%). Conclusion Schools differed substantially in their preparedness to manage anaphylaxis, with significant disparities in staff training and permission to treat. Given the ramifications of delayed treatment, removing barriers to the recognition and treatment of anaphylactic events in schools is an important public health goal.

Elementary School–Located Influenza Vaccine Programs: Key Stakeholder Experiences From Initiation to Continuation

This study examined the initiation and logistics, funding, perceived barriers and benefits, and disruption of school activities by school-located influenza vaccination (SLIV) programs conducted during the 2008–2009 influenza season. Seventy-two interviews using a structured protocol were conducted with 26 teachers, 16 school administrators, and 30 health care professionals from 34 schools in 8 school districts. SLIV programs used a variety of locations, scheduling and staffing options, and methods for receiving parental consent and screening children. Health care professionals were primarily responsible for implementing SLIV programs, and most administrators and health care professionals considered programs easy to initiate. Health care professionals identified successful programs as requiring adequate planning/coordination, a dedicated program coordinator, and a consistent funding source. Most respondents (96%) reported minimal school-day disruptions. The perception of most stakeholders is that SLIV programs can be relatively easy to initiate, minimally disruptive and can become more efficient with experience, especially with feedback from all stakeholders.

The relationship between dosing of alosetron and discontinuation patterns reported by patients participating in a follow-up programme

Alosetron was reintroduced for treatment of irritable bowel syndrome with a risk management programme in November 2002. Recommended starting dosage was 1u2003mg/day for 4u2003weeks. If symptoms remained uncontrolled, dosage could be changed to 2u2003mg/day.

Work Productivity and Activity Impairment Among Chronic Spontaneous/Idiopathic Urticaria Patients: ResultsFrom The First International Burden of Illness Study (Assure-Csu).

SPONTANEOUS/IDIOPATHIC URTICARIA PATIENTS: RESULTS FROM THE FIRST INTERNATIONAL BURDEN OF ILLNESS STUDY (ASSURE-CSU) Balp MM1, Chambenoit O2, Chiva-Razavi S2, Lynde C3, Sussman G4, Chapman-Rothe N5, Weller K6, Maurer M6, Koenders J7, Knulst AC8, Halliday A9, Alexopoulos ST9, Nakonechna A10, Grattan C11, Abuzakouk M12, Sweeney C13, Radder C13, Wolin D14, McBride D15, Hollis K13, Tian H16, Oude Elberink JNG17 1Novartis Pharma AG, Basel, Switzerland | 2Novartis Pharmaceuticals Canada Inc., Dorval, QC, Canada | 3Lynderm Research Inc., Toronto, ON, Canada | 41St Michael’s Hospital, University of Toronto, Toronto, ON, Canada | 5Novartis Pharma GmbH, Nuernberg, Germany | 6Charite Universitatsmedizin Berlin, Berlin, Germany | 7Novartis Pharma B.V., Arnhem, Netherlands | 8University Medical Center Utrecht, Utrecht, Netherlands, 9Novartis Pharmaceuticals UK Limited, Surrey, United Kingdom | 10Royal Liverpool and Broadgreen University Hospitals NHS Trust, United Kingdom | 11Norfolk and Norwich University Hospital, Norwich, United Kingdom, 12Cleveland Clinic Abu Dhabi, Al Maryah Island, Abu Dhabi, UAE | 13RTI Health Solutions, Research Triangle Park, NC, USA | 14RTI Health Solutions, Ann Arbor, MI, USA | 15RTI Health Solutions, Manchester, United Kingdom | 16Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA | 17University Medical Center Groningen, Groningen, Netherlands

Anaphylaxis in Schools: Results of the EPIPEN4SCHOOLS Survey Combined Analysis.

A pilot survey described the characteristics of anaphylactic events occurring in an initial set of participating U.S. schools during the 2013–2014 school year. This survey was subsequently readministered to large school districts, which were underrepresented in initial results. A cross-sectional survey was administered to the U.S. schools that were participating in the EPIPEN4SCHOOLS® program (Mylan Specialty L.P., Canonsburg, PA) to assess characteristics of anaphylactic events. Data from large school districts were added to initial findings in this comprehensive combined analysis. A total of 1,140 anaphylactic events were reported among 6,574 responding schools. Of 1,063 anaphylactic events with data on who experienced the event, it was observed that it occurred mostly in students (89.5%, 951/1,063). For students, anaphylactic events were reported across all grades, with 44.9% (400/891) occurring in high school students, 18.9% (168/891) in middle school students, and 32.5% (290/891) in elementary school students. Food was identified as the most common trigger (60.1%, 622/1,035). A majority of schools (55.0%, 3,332/6,053) permitted only the school nurse and select staff to administer epinephrine to treat anaphylaxis. The unpredictability of anaphylaxis is emphasized by its high occurrence in individuals with no known allergies (25.0%). A majority of schools permitted only the school nurse and select staff to treat anaphylaxis. Thus, individuals experiencing an anaphylactic event may frequently encounter staff members not being permitted to administer potentially life-saving epinephrine. Epinephrine auto-injectors provided by the EPIPEN4SCHOOLS program were used to treat 38.0% of events. Anaphylaxis can occur in children with no previously known allergies, illustrating the importance of public access to epinephrine.

Comparison of Urticaria Activity Score Over 7 Days (UAS7) Values Obtained from Once-Daily and Twice-Daily Versions: Results from the ASSURE-CSU Study

BackgroundThe Urticaria Activity Score summed over 7xa0days (UAS7) assesses the itch severity and hive count in chronic spontaneous urticaria (CSU) using once- or twice-daily diary-based documentation.ObjectiveThe aim of this study was to evaluate the comparability of twice-daily versus once-daily versions of the UAS and the resulting UAS7 values.MethodsData came from the ASSURE-CSU study. The twice-daily and once-daily UAS7 was calculated from morning and evening ratings, as well as from exact 24-h evening ratings of hive count and itch severity, respectively. Three UAS7 scores were computed: UAS7 twice daily (UAS7TD), UAS7 once daily for maximum itch (UAS7OD1MAX), and UAS7 once daily for average itch (UAS7OD2AVG). UAS7 values were assigned to five score bands (0, 1–6, 7–15, 16–27, 28–42), reflecting urticaria-free to severe disease activity. The score values and score band ratios of the UAS7TD and UAS7OD versions were compared and assessed for correlation by weighted Cohen’s kappa statistics.ResultsData from 614 patients were analyzed. All three versions of the UAS7 yielded very similar results, with a mean (standard deviation) UAS7TD, UAS7OD1MAX, and UAS7OD2AVG of 17.3 (10.49), 17.7 (8.90), and 16.2 (8.68), respectively. Correlation coefficients between UAS7TD and UAS7OD1MAX, UAS7TD and UAS7OD2AVG, and UAS7OD1MAX and UAS7OD2AVG were 0.94, 0.95, and 0.99, respectively, showing very high positive pairwise correlation. The weighted kappa coefficient, κ (95% confidence interval) was 0.78 (0.75–0.82) for UAS7TD versus UAS7OD1MAX, and 0.82 (0.78–0.85) for UAS7TD versus UAS7OD2AVG, demonstrating substantial agreement.ConclusionsThe once- and twice-daily UAS7 scores were highly consistent, supporting the use of either version when evaluating CSU activity.