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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...
August 18, 2016: 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
Aniket A Kawatkar, Tara K Knight, Robert A Moss, Vanja Sikirica, Li-Hao Chu, Paul Hodgkins, M Haim Erder, Michael B Nichol
OBJECTIVE: To estimate the health resource use (HRU) and expenditure of adult patients with attention deficit/hyperactivity disorder (ADHD) subsequently diagnosed with one or more mental health (MH) comorbidities. METHODS: Using Kaiser Permanente Southern California electronic medical records (January 1, 2006, to December 31, 2009), we identified adults with at least one ADHD diagnosis and at least two subsequent prescriptions fills for ADHD medication. The date of first MH comorbidity diagnosis after the index ADHD diagnosis was defined as the index transition date...
September 2014: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Juliana Setyawan, Moshe Fridman, Paul Hodgkins, Javier Quintero, M Haim Erder, Božena J Katić, Valerie Harpin
We evaluated the association between those symptoms/behaviours of attention-deficit/hyperactivity disorder (ADHD) that were present at diagnosis and outcomes of treatment in children and adolescents in six European countries. Physicians abstracted clinical records from patients (6-17 years) diagnosed with ADHD between 2004 and 2007 and treated for ≥2 years. Physicians scored the severity of impairment for core ADHD symptoms and additional (non-core) ADHD symptoms/behaviours at diagnosis and estimated treatment adherence (defined as an estimated >80 % adherence on weekdays and >50 % adherence on weekends)...
March 2015: Attention Deficit and Hyperactivity Disorders
Eric Q Wu, Paul E Greenberg, Rym Ben-Hamadi, Andrew P Yu, Elaine H Yang, M Haim Erder
BACKGROUND: Major depressive disorder is the most common type of depression, affecting 6.6% of adults in the United States annually. Citalopram and escitalopram are common second-generation antidepressants used for the treatment of patients with this disorder. Because citalopram is available in generic forms that have lower acquisition costs compared with the branded escitalopram, some health plans may provide incentives to encourage the use of the generic option. Decisions based solely on drug acquisition costs may encourage the use of a therapy that is less cost-effective when treatment persistence, healthcare utilization, and overall costs are factored in...
March 2011: American Health & Drug Benefits
Brennan M R Spiegel, Mark W Reid, Roger Bolus, Cynthia B Whitman, Jennifer Talley, Stanley Dea, Kamyar Shahedi, Hetal Karsan, Chassidy Teal, Gil Y Melmed, Erica Cohen, Garth Fuller, Linnette Yen, Paul Hodgkins, M Haim Erder
BACKGROUND: Colonic diverticular disease is typically conceived as acute diverticulitis attacks surrounded by periods of clinical silence. However, evolving data indicate that many patients have persistent symptoms and diminished health-related quality of life (HRQOL) long after acute attacks. We developed a disease-targeted HRQOL measure for symptomatic uncomplicated diverticular disease (SUDD)-the diverticulitis quality of life (DV-QOL) instrument. METHODS: We conducted a systematic literature review to craft a conceptual model of SUDD HRQOL...
January 2015: Quality of Life Research
Keith A Betts, Vanja Sikirica, Paul Hodgkins, Zhou Zhou, Jipan Xie, Anthony DeLeon, M Haim Erder, Eric Q Wu
OBJECTIVE: Stimulants are recommended as a first-line treatment for attention- deficit/hyperactivity disorder (ADHD); however, a subset of the patient population augments their stimulant treatment with other medications. The objective of this study was to estimate the 1 year period prevalence of concomitant psychotropic medication use among children and adolescents with ADHD during 2009. METHODS: Patients 6-17 years of age with one or more primary ADHD diagnoses between July 1, 2008 and December 31, 2009 and one or more stimulant prescription fills during 2009 were identified from a large United States commercial claims database...
June 2014: Journal of Child and Adolescent Psychopharmacology
Tara K Knight, Aniket Kawatkar, Paul Hodgkins, Robert Moss, Li-Hao Chu, Vanja Sikirica, M Haim Erder, Michael B Nichol
OBJECTIVES: To estimate longitudinal trends in prevalence and incidence rates of adult ADHD 2006-2009. RESEARCH DESIGN AND METHODS: Kaiser Permanente Southern California (KPSC) electronic medical records were analyzed to assess prevalence and incidence rates for adult ADHD. Trends over time were estimated and compared using three case definitions (ADHD diagnosis only [DX], ADHD DX and ≥2 FDA-approved ADHD prescriptions [DX + RX], and ADHD DX and ≥1 behavioral therapy visit [DX + BT])...
July 2014: Current Medical Research and Opinion
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