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Emuella Flood, Debra G Silberg, Beverly Romero, Kathleen Beusterien, M Haim Erder, Carmen Cuffari
BACKGROUND: The purpose of this study is to develop patient-reported (PRO) and observer-reported (ObsRO) outcome measures of ulcerative colitis (UC) signs/symptoms in children aged 5-17 with mild/moderate UC. The daily ulcerative colitis signs and symptoms scale (DUCS) was developed in two phases. Phase I involved concept elicitation interviews with patients and healthcare providers, review of website posts and item generation. Phase II involved cognitive debriefing and assessment of usability and feasibility of the eDiaries...
September 25, 2017: BMC Research Notes
Adam Strzelczyk, Sonja Ansorge, Jana Hapfelmeier, Vijayveer Bonthapally, M Haim Erder, Felix Rosenow
OBJECTIVE: Super-refractory status epilepticus (SRSE) is a severe condition in which a patient in status epilepticus (SE) for ≥24 h does not respond to first-, second-, or third-line therapy. The economic impact of SRSE treatment remains unclear. A health insurance research database was used for a population-based estimation of SRSE-associated inpatient costs, length of stay, and mortality in Germany. METHODS: An algorithm using International Classification of Diseases, 10th Edition coding and treatment parameters identified and classified patients in a German statutory health insurance database covering admissions from 2008 to 2013 as having refractory SE (RSE) or SRSE...
September 2017: Epilepsia
Louis S Matza, Mary Kay Margolis, Linda S Deal, Kimberly F Farrand, M Haim Erder
BACKGROUND: Informant-reported outcome measures, usually completed by parents, are often administered in pediatric clinical trials with the intention of collecting data to support claims in a medical product label. Recently, there has been an emphasis on limiting these measures to observable content, as recommended in the US Food and Drug Administration guidance on patient-reported outcomes. This qualitative study explores the concept of observability using the example of childhood attention deficit/hyperactivity disorder (ADHD)...
June 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Moshe Fridman, Tobias Banaschewski, Vanja Sikirica, Javier Quintero, M Haim Erder, Kristina S Chen
The caregiver perspective on pediatric attention-deficit/hyperactivity disorder (ADHD) study (CAPPA) was a web-based, cross-sectional survey of caregivers of children and adolescents (6-17 years of age) with ADHD and was conducted in 10 European countries. CAPPA included caregiver assessments of global medication satisfaction, global symptom control, and satisfaction with ADHD medication attributes. Overall, 2,326 caregiver responses indicated that their child or adolescent was currently receiving ADHD medication and completed the "off medication" assessment required for inclusion in the present analyses...
2017: Neuropsychiatric Disease and Treatment
Moshe Fridman, Tobias Banaschewski, Vanja Sikirica, Javier Quintero, M Haim Erder, Kristina S Chen
BACKGROUND: Burden on caregivers of children/adolescents with attention-deficit/hyperactivity disorder (ADHD) is multidimensional, but incompletely understood. OBJECTIVE: To analyze caregiver burden across the concepts of work, social/family life, and parental worry/stress, in relation to selected contributing factors. METHODS: The online Caregiver Perspective on Pediatric ADHD survey was fielded in ten European countries. Analysis included children/adolescents (6-17 years) who were receiving/had received ADHD pharmacotherapy in the previous 6 months...
2017: Neuropsychiatric Disease and Treatment
Garth Fuller, Roger Bolus, Cynthia Whitman, Jennifer Talley, M Haim Erder, Alain Joseph, Debra G Silberg, Brennan Spiegel
BACKGROUND: Most patients with gastroesophageal reflux disease (GERD) experience relief following treatment with proton pump inhibitors (PPIs) (Vakil et al. in Am J Gastroenterol 101:1900-1920, 2006; Everhart and Ruhl in Gastroenterology 136:376-386, 2009). As many as 17-44% of patients, however, exhibit only partial response to therapy. Most extant GERD patient-reported outcome (PRO) instruments fail to meet development best practices as described by the FDA (Talley and Wiklund in Qual Life Res 14:21-33, 2005; Van Pinxteren et al...
March 2017: Digestive Diseases and Sciences
Jason Shafrin, Anshu Shrestha, Amitabh Chandra, M Haim Erder, Vanja Sikirica
Differences in patient characteristics across trials may bias efficacy estimates from indirect treatment comparisons. To address this issue, matching-adjusted indirect comparison (MAIC) measures treatment efficacy after weighting individual patient data to match patient characteristics across trials. To date, however, there is no consensus on how best to implement MAIC. To address this issue, we applied MAIC to measure how two attention-deficit/hyperactivity disorder (ADHD) treatments (guanfacine extended release and atomoxetine hydrochloride) affect patients' ADHD symptoms, as measured by the ADHD Rating Scale IV score...
September 13, 2016: Health Economics
Paul Hodgkins, Andrew Lloyd, M Haim Erder, Juliana Setyawan, Margaret D Weiss, Rahul Sasané, Beenish Nafees
OBJECTIVE: Defining minimal important difference (MID) is critical to interpreting patient-reported outcomes data and treatment efficacy in clinical trials. This study estimates the MID for the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) and the Child Health and Illness Profile-Parent Report (CHIP-CE-PRF76) among parents of young people with attention-deficit/hyperactivity disorder (ADHD) in the UK. METHODS: Parents of children (6-12 years; n=100) and adolescents (13-17 years; n=117) with ADHD completed a socio-demographic form, the CHIP-CE-PRF76, the WFIRS-P, and the Pediatric Quality of Life scale at baseline and 4 weeks later...
February 2017: CNS Spectrums
Nicole Cossrow, Manjiri Pawaskar, Edward A Witt, Eileen E Ming, Timothy W Victor, Barry K Herman, Thomas A Wadden, M Haim Erder
OBJECTIVE: To estimate binge eating disorder (BED) prevalence according to DSM-5 and DSM-IV-TR criteria in US adults and to estimate the proportion of individuals meeting DSM-5 BED criteria who reported being formally diagnosed. METHODS: A representative sample of US adults who participated in the National Health and Wellness Survey were asked to respond to an Internet survey (conducted in October 2013). Assessments included 3-month, 12-month, and lifetime BED prevalence based on DSM-5 and DSM-IV-TR criteria and demographics, psychiatric comorbidities, and self-esteem (Rosenberg Self-Esteem Scale)...
August 2016: Journal of Clinical Psychiatry
J Shafrin, V Sikirica, A Shrestha, L E Henkhaus, M H Erder, A Chandra
No abstract text is available yet for this article.
November 2014: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Emuella Flood, Kavita Gajria, Vanja Sikirica, C Noelle Dietrich, Beverly Romero, Valerie Harpin, Tobias Banaschewski, Javier Quintero, M Haim Erder, Moshe Fridman, Kristina Chen
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder that affects the lives of patients and their families. The Caregiver Perspective on Paediatric ADHD (CAPPA) survey was conducted to evaluate the burden associated with ADHD in Europe and to identify unmet needs. Here, we describe sociodemographic and clinical characteristics, treatment use and impact of ADHD. METHODS: The cross-sectional web-based CAPPA survey was fielded in 10 European countries among caregivers of children/adolescents (aged 6-17 years) with ADHD who were currently receiving or had received pharmacotherapy in the previous 6 months...
August 2016: Journal of Affective Disorders
Demet Cicek, Betul Demir, Ilker Erder, Tuncay Kuloglu, Ozlem Ucer, Suleyman Aydin, Haydar Ucak, Selma Dertlioglu, Mehmet Kalayci
BACKGROUND: Ghrelin in the pilosebaceous tissues of human skin and ghrelin levels in patients with acne vulgaris have not yet been investigated. OBJECTIVE: The purpose of this study was to screen ghrelin immunoreactivity by immunohistochemistry in human pilosebaceous tissues of human skin and also to determine the quantities of ghrelin in the serum of the patients with acne vulgaris. METHODS: 30 patients presenting with acne vulgaris and 30 control subjects participated in this study...
July 2015: European Journal of Dermatology: EJD
Kavita Gajria, Mark Kosinski, Vanja Sikirica, Michael Huss, Elayne Livote, Kathleen Reilly, Ralf W Dittmann, M Haim Erder
BACKGROUND: Measurement properties of the Weiss Functional Impairment Rating Scale-Parent Report Form (WFIRS-P), which assesses attention-deficit/hyperactivity disorder (ADHD)-related functional impairment in children/adolescents (6-17 years), were examined. METHODS: Data from seven randomized, controlled trials were pooled. Analyses were conducted in two random half-samples. WFIRS-P conceptual framework was evaluated using confirmatory factor analyses (CFA). Reliability was estimated using internal consistency (Cronbach's alpha) and test-retest reliability methods...
2015: Health and Quality of Life Outcomes
Juliana Setyawan, Hongbo Yang, David Cheng, Xiaopeng Cai, James Signorovitch, Jipan Xie, M Haim Erder
OBJECTIVE: To develop a risk score for treatment failure that could potentially be used to individualize treatment selection between lisdexamfetamine dimesylate (LDX) and osmotic-release oral system methylphenidate (OROS-MPH) in children and adolescents with attention deficit/hyperactivity disorder (ADHD). METHODS: The study used data from patients with ADHD receiving LDX (N = 104) or OROS-MPH (N = 107) in a phase III randomized clinical trial. A prediction model was developed to estimate risk scores for failing OROS-MPH, where treatment failure was defined as less than 25% improvement in the ADHD Rating Scale IV total score from baseline...
September 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Asha Hareendran, Juliana Setyawan, Robin Pokrzywinski, Anna Steenrod, Manisha Madhoo, M Haim Erder
BACKGROUND: Engaging adolescents in decisions about their health may enhance their compliance with treatment and result in better health outcomes. Treatment outcomes in attention-deficit/hyperactivity disorder (ADHD) are rarely evaluated from the adolescents' point of view. There is also concern that adolescents with ADHD may not have insight about the impacts of their disease. This article describes research conducted to understand the experiences of adolescents with ADHD and how the research was used to develop an adolescent self-report instrument...
2015: Health and Quality of Life Outcomes
M Fridman, P S Hodgkins, J S Kahle, M H Erder
BACKGROUND: There are few approved therapies for adults with attention-deficit/hyperactivity disorder (ADHD) in Europe. Lisdexamfetamine (LDX) is an effective treatment for ADHD; however, no clinical trials examining the efficacy of LDX specifically in European adults have been conducted. Therefore, to estimate the efficacy of LDX in European adults we performed a meta-regression of existing clinical data. METHODS: A systematic review identified US- and Europe-based randomized efficacy trials of LDX, atomoxetine (ATX), or osmotic-release oral system methylphenidate (OROS-MPH) in children/adolescents and adults...
June 2015: European Psychiatry: the Journal of the Association of European Psychiatrists
Moshe Fridman, M Haim Erder
BACKGROUND AND OBJECTIVES: The retrospective comparison of test and reference treatment arms in a randomized prospective clinical trial is potentially useful in economic modeling seeking to assess the cost effectiveness of alternative therapies. METHODS: To enhance the credibility of such retrospective comparisons, we propose the application of the following adjustments to significance levels obtained from standard statistical methodology: (1) a significance test for the lower bound of the 95 % confidence interval for the observed difference, (2) a conservative Bonferroni method of adjustment for multiple comparisons, (3) an adjusted p-value calculated using Scheffe's single-step method, and (4) Bayesian 95 % credibility intervals with a prior centered at zero...
February 2015: Clinical Drug Investigation
Vanja Sikirica, Steven R Pliszka, Keith A Betts, Paul Hodgkins, Thomas M Samuelson, Jipan Xie, M Haim Erder, Ryan S Dammerman, Brigitte Robertson, Eric Q Wu
OBJECTIVES: To compare treatment patterns, resource utilization, and costs to US third-party payers of stimulant-treated adolescent attentiondeficit/ hyperactivity disorder (ADHD) patients who switched to or augmented with atypical antipsychotics (AAPs; not FDA-indicated for ADHD) with those who switched to or augmented with nonantipsychotic medications. STUDY DESIGN: Retrospective cohort study conducted using a US commercial medical/pharmacy claims database. METHODS: Adolescent patients with an ADHD diagnosis and ≥ 1 stimulant medication claim between January 2005 and December 2009 were identified...
September 2014: American Journal of Managed Care
Vanja Sikirica, Emuella Flood, C Noelle Dietrich, Javier Quintero, Val Harpin, Paul Hodgkins, Klaus Skrodzki, Kathleen Beusterien, M Haim Erder
INTRODUCTION: Attention-deficit/hyperactivity disorder (ADHD) is a neurobehavioral disorder characterized by inattention, impulsivity, and hyperactivity, the levels of which are inappropriately high for an individual's developmental age. OBJECTIVE: The objective of this study was to explore the unmet needs of children/adolescents with ADHD and their caregivers in eight European countries. METHODS: Semi-structured interviews with 38 caregivers of children/adolescents (aged 6-17 years) with ADHD and no or less serious comorbidities and 28 adolescents (aged 13-17 years) with ADHD and no or less serious comorbidities were conducted, audio-recorded, transcribed into English, and coded for analysis...
June 2015: Patient
Aniket Kawatkar, Li-Hao Chu, Rajan Iyer, Linnette Yen, Wansu Chen, M Haim Erder, Paul Hodgkins, George Longstreth
PURPOSE: The objectives of this study were to develop and validate algorithms to accurately identify patients with diverticulitis using electronic medical records (EMRs). METHODS: Using Kaiser Permanente Southern California's EMRs of adults (≥18 years) with International Classification of Diseases, Clinical Modifications, Ninth Revision diagnosis codes of diverticulitis (562.11, 562.13) between 1 January 2008 and 31 August 2009, we generated random samples for pilot (N = 692) and validation (N = 1502) respectively...
January 2015: Pharmacoepidemiology and Drug Safety
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