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SELF-REPORTED MEDICATION NECESSITY AND CONTINUATION OF STIMULANT THERAPY IN ADOLESCENTS DIAGNOSED WITH ADHD. Zachary A. Pape, PharmD Candidate 2016 [email protected] SPECIFIC AIMS The most common childhood neuro-behavioral disorder is currently ADHD.1 As medication and pharmacological use becomes common in everyday life, the importance of diagnosis and appropriate treatment of ADHD will grow. According to a summary of health statistics for US children conducted by the Centers for Disease Control (CDC) in 2012, 10% of children aged 317 years old were diagnosed with ADHD, equating to about 5 million children.2 The 2011 National Survey of Children’s Health (NSCH) reported that 11% of school aged children (6.4 million) had received a diagnosis, and 6.1% of school children (3.5 million) were taking some form of ADHD stimulant medication.3 These findings regarding diagnosis and treatment relay the importance of fully understanding treatment regimens using stimulant medication and what type of effects they have on maturation, behavior, and dependence on pharmacologic assistance. There have been several studies about use of stimulant medications for treatment of ADHD internationally. There is a gap in knowledge where little has been done here in the United States regarding research on long-term effectiveness, dependence/necessity, and duration of stimulant medication therapy.4 It has been shown that stimulants have a positive response in terms of ADHD symptoms, which consists of hyperactivity and impulsivity beyond that of someone that is within the normal range at the same developmental level.5,6 For some children and adolescents there may be longlasting neurocognitive deficits in patients diagnosed with ADHD that do not receive treatment.7 The overall objective of this study is to determine an appropriate duration of therapy regarding stimulant medication use in adolescents diagnosed with ADHD based on self-perceived necessity. We hypothesize that differences in clinical predictors and treatment beliefs will result in a variance among the appropriate duration of therapy and perceived medication necessity on a patient-to-patient basis. In order to test our hypothesis, we propose the following specific aims: To determine the prevalence of self-reported perceived medication necessity in those who take stimulant ADHS medication. The working hypothesis is that there exists a variance in perceived medication necessity within those on a stimulant ADHD medication. To determine the predictors of self-perceived medication necessity. Aligning with past literature, the working hypothesis is that potential predictors will consist of clinical factors such as age at time of diagnoses, and treatment duration, as well as treatment beliefs which will be able predict perceived medication necessity. There are two expected outcomes. First, we expect to find that there is a significant variance between patients on their self-reported need for stimulant therapy continuation beyond the age of 18. This is because ADHD and its treatment are not objective in their measurement and choice of therapy. Second, we expect to see that clinical factors and treatment beliefs have a significant impact on perceived medication necessity because a patients personal beliefs are likely to play a large role in neuropsychiatric disorders like ADHD. INTRODUCTION Attention-deficit and hyperactivity disorder is recognized as neuro-developmental disorder that can result in performance issues in social, educational, and work settings. It presents with two 1 types of symptoms, inattention and hyperactivity. Patients that show these symptoms as defined by the American Psychiatric Association (APA) for at least 6 months are considered to have the disorder, and should be diagnosed and treated appropriately.8 The neuro-behavioral disorder that is the most common among children today is ADHD.1 The relevance of this disorder is growing every single day, which means that the appropriate diagnosis and treatment via the current DSM-V criteria developed by the APA is of utmost importance. According to a summary of health statistics for US children conducted by the Centers for Disease Control (CDC) in 2012, 10% of children aged 3-17 years old were diagnosed with ADHD, equating to about 5 million children.2 The 2011 National Survey of Children’s Health (NSCH) reported that 11% of school aged children (6.4 million) had received a diagnosis, and 6.1% of school children (3.5 million) were taking some form of ADHD stimulant medication.3 Additionally, use of ADHD medications are associated with an increased average out-of-pocket expenses of $386 for children, compared to $202 for children without ADHD medications.9 What has not been established regarding stimulant medication use in children, is the duration of treatment for the chronic condition. Approximately one-third of children that are diagnosed with ADHD maintain that diagnosis through adulthood, making it a chronic condition that may require long term pharmaceutical intervention.10 Although some literature has been able to view the condition on a long-term scale, there is no established duration of treatment due to the individualistic nature of the condition. It has been shown that stimulants have a positive response on the both hyperactivity and impulsivity symptoms of ADHD, beyond that of someone that is within the “normal range” at the same developmental level.5,6 It is important to understand that the patient is an integral part in the decision of what types of treatments will be effective. Patient beliefs are important in the treatment in many types of disorders, but would seemingly have a larger impact on neurological disorders in particular. Thus, the patient perceptions about the necessity of their stimulant medication or their reliance on them for day-to-day activities may be a large factor in their duration of treatment. Many current or past stimulant users have reported that the use of stimulant medications are able to improve social skills as well as improve ability to do work in the classroom.11 These skills are vital to children and adolescents of a younger age and could be the reason why diagnosis and treatment using stimulants is so high. The thought processes and beliefs of adolescents have been examined in some studies to show that there are ups and downs to stimulant use.12 Adolescents show less of a willingness to use medications in terms of beginning therapy because they often see it as more of a hassle than something that can help them.13 This can lead to further social and academic struggles and result in poor control over the condition. Patients have reported “not feeling themselves” while taking their medication as well.3 While other studies examined that adolescents’ views on the medication they take, and how their beliefs about the effectiveness or necessity can sometimes negatively affect adherence.14 Inappropriate adherence can potentially prolong treatment in any disease state, although it is not known if that is the case for ADHD. The objective of this study was to determine if individuals’ perceived medication necessity and other clinical factors such as age, time of diagnosis, and treatment beliefs had an effect on their continuation of stimulant ADHD medication into adulthood. THEORETICAL FRAMEWORK 2 For this study, parts of two different baseline frameworks are utilized in order to achieve study objectives and measure medication necessity. A look at patient’s perceptions about stimulant medication use in the treatment of ADHD can be applied through the Theory of Planned Behavior and the Integrated Behavioral Model. These processes have been successfully employed in other studies that examine patient behaviors, however, for this study components of the models will be utilized to form an idea of patient perceptions regarding stimulant use and the perceived need for continuation.15 Horne’s medication belief theory was also sampled from to gather more information on patient medication belief and its potential role in necessity of stimulant medication. It is able to better predict patient’s specific beliefs and behaviors. The necessity and specific-concern sub-scales were utilized via the Belief about Medicines Questionnaire or BMQ-specific scale.16 The Theory of Reasoned Action (TRA) and Theory of Planned Behavior (TPB) were developed by Martin Fishbein and Icek Ajzen in the late 70’s and early 80’s which described a model that focused on attitudes towards specific and social norm perceptions of a behavior in order to predict a person’s behavioral intention.17 These models have been successfully used to predict and explain many health behaviors including smoking, drinking, exercise, and many more. Originally TRA and TPB were developed to understand the relationships between attitudes, intentions and behaviors. Since this time, theorists have developed the new Integrated Behavioral Model (IBM), which includes components of the two previous models from Ajzen and Fishbein, yet also include constructs from other influential theories.15 The most important determinant of a behavior is the intention to perform that behavior, according to the IBM. There are five major components of the behavior; intention to perform, knowledge and skill, environmental constraints, salience, and previous performance of the behavior. The three construct categories in the IBM are attitude, perceived norm, and personal agency (perceived self-efficacy and perceived control). There is variance on the importance of these three constructs based on the behavior being tested in the study. This framework is primarily used to identify specific belief targets for a behavioral change. It will focus on specific behaviors in which a change is desirable, and identify where further research and study can look to make that change.15 Horne’s Belief about Medicines Questionnaire and model states that a person’s belief about their medication are impacted by two factors, concern and necessity. Typically both concepts are impacted heavily by negative past experiences, through medication related drug reactions or need of the medication to prevent recurring medical problems. For this study, medication necessity in patients with ADHD is the focus, therefore only the necessity component of Horne’s theory will be utilized.16 In ADHD there is often a disagreement on what type of behavior is commonly associated with a patient taking stimulant medications. Some patients believe that the medication is essential to their success in everyday life (school, work, and social interaction)12, whereas other studies have shown that the majority of the patients have a goal of being taken off of stimulant medication or find it burdensome.14,18 METHODS This methods section will focus on specific aim #1: 3 To determine the prevalence of self-reported perceived medication necessity in those who take stimulant ADHS medication. Design: This study used non-experimental study design with a combination of health system obtained EMR retrospective data, and two online surveys (via the Qualtrics program), to be filled out by the patient individually. Subjects: Patients and their guardians from the various health systems located in the state of Iowa. Inclusion Criteria – Age 14-18 years old Current or past diagnosis of ADHD based on DSM-IV criteria Currently using stimulant medication as treatment for ADHD for 3 or more consecutive months Parental or legal guardian consent (if younger than 18 years old) Sampling: The study initially screened the EMR for patients that were between 14-18 years old, were diagnosed with ADHD, and are currently taking stimulant medication indicated for their disorder for at least 3 consecutive months. The study sampled 200 patients in order to reach a goal of 100 subjects. Subjects that fully completed patient surveys were entered into a raffle for four $100 pre-loaded debit cards. Data Collection: The study will collect data from the Iowa health Systems’ EMR for demographic, diagnostic, and medication related information. Each patient sampled received a phone call to the telephone-number indicated as their primary contact on the EMR. Phone calls were place at baseline, 2 weeks, and if no response was heard by 4 weeks then the patient was mailed the information. For patients that responded by expressing interest, they were emailed a link to an online survey to complete which included the necessary IRB approved information regarding the study, and a consent to participate in the study. The online survey was followed by IRB and study coordinator contact information for comments and questions. MEASURES OF INTEREST Demographics: Information collected about child age, gender, race, were obtained via the EMR. See Appendix A and Appendix B. Some demographic information such as age, sex, and ethnicity can be obtained via the EMR (Appendix A). Other questions such as ‘number of parents/guardians in the household’ and ‘number of people that live in the household’ can only be obtained via subject response (Appendix B). Clinical Characteristics: Characteristics such as date of diagnosis, date of treatment initiation (date of first prescribed stimulant), and specific simulant medication(s) being taken via the EMR and patient survey information (Appendix A). Patients also completed the Columbia Impairment Scale (CIS) youth version to assess global functioning in domains of interpersonal relations, psychopathology, school performance, and use of leisure time. The CIS form is validated and commonly used by clinicians via the American Academy of Pediatrics (AAP). (Appendix C)19,20 Medication Necessity: Before completing the survey patients were asked to checkmark what medications on our provided stimulant list they might take (see Appendix B), in order to establish patient understanding of stimulant medications. The outcome for this aim was 4 measured based off of the answers to the specific question via the BMQ-specific scale, necessity sub-scale. ‘My health at present depends on my medicines’, ‘My life would be impossible without my medicines’, ‘Without my medicines, I would be very ill’, ‘My health in the future will depend on my medicines’, and ‘My medicines protect me from becoming worse’. The questionnaire has been validated and tested for internal consistency and psychometric properties, and it assesses the cognitive representation of medication. Though using only part of the BMQ has not been fully validated alone.16 Treatment Opinion: Patients answered questions modeled from the Child and Adolescent Services Assessment (CASA) Version 5.0. ‘I feel/felt like using stimulant medications to treat my ADHD was good for me’ and ‘I feel/felt like I should continue my ADHD medication’. (Appendix B)21 STATISTICAL ANALYSIS: Normality of variables will be determined visually be conducting histograms and normality plots. Skewness and Kurtosis values will also be determined. If a variable is determined to not be normal, the variable will be handled by transformation, or categorization. Standing scores of all variables will allow us to identify any potential outliers. Any outliers identified will be handled by removal. Frequencies and descriptives will be performed on all variables. Pearson and Spearman correlations will be executed between all variables to determine correlation. All variables were collected via the EMR and patient survey responses in Qualtrics, then analyzed using SPSS technology. LIMITATIONS: Limitations to this study center on external validity regarding sample size and generalizability. Because of a smaller sample size and a specifically screened population that used subjects on a voluntary basis via an electronic source. There are implicit differences between people that volunteer for studies that have access to electronic reources and people that do not, because of this the study is only generalizable to specific populations. Additionally there is a potential for threats to construct validity. The measures for medication necessity are being evaluated through several different pieces of necessity or behavioral models, the measures may not be fully validated in this new way they are being presented. This is a study looking at descriptive statistics in a very specific population, therefore, threats to external validity are unavoidable and not of our concern. Additionally, any threats to construct validity are deemed necessary for this study which looks at a new approach to medication necessity. 5 References: 1. Raishevich N, Jensen P. Attention deficit hyperactivity disorder. In: Kliegman, editor. Nelsons textbook of pediatrics. 18th ed. Philadelphia PA: W.B Saunders; 2007. 2. Bloom B, Jones LI, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2012. Vital Health Stat 10. 2013;(258):1-81. 3. Visser SN, Danielson ML, Bitsko RH, et al. Trends in the parent-report of health care provider-diagnosed and medicated attention-deficit/hyperactivity disorder: United States, 2003-2011. J Am Acad Child Adolesc Psychiatry. 2014;53(1):34-46.e2. 4. Nigg JT. Attention-deficit/hyperactivity disorder and adverse health outcomes. Clin Psychol Rev. 2013;33(2):215-28. 5. Barbaresi WJ, Katusic SK, Colligan RC, Weaver AL, Leibson CL, Jacobsen SJ. Long-term stimulant medication treatment of attention-deficit/hyperactivity disorder: results from a population-based study. J Dev Behav Pediatr. 2014;35(7):448-57. 6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders DSM-IVTR. 4th Edition. Washington, DC: American Psychiatric Association; 2000. Attentiondeficit and disruptive behavior disorders; p. 85-93.(Text Revision). 7. Wang LJ, Chen CK, Huang YS. Neurocognitive Performance and Behavioral Symptoms in Patients with Attention-Deficit/Hyperactivity Disorder During Twenty-Four Months of Treatment with Methylphenidate. J Child Adolesc Psychopharmacol. 2015. 8. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Arlington, VA., American Psychiatric Association, 2013. 9. Chan E, Zhan C, Homer CJ. Health care use and costs for children with attentiondeficit/hyperactivity disorder: national estimates from the medical expenditure panel survey. Arch Pediatr Adolesc Med. 2002;156(5):504-11. 10. Barbaresi WJ, Colligan RC, Weaver AL, Voigt RG, Killian JM, Katusic SK. Mortality, ADHD, and psychosocial adversity in adults with childhood ADHD: a prospective study. Pediatrics. 2013;131(4):637-44. 11. Pillow DR, Naylor LJ, Malone GP. Beliefs Regarding Stimulant Medication Effects Among College Students With a History of Past or Current Usage. Journal of Attention Disorders. 2014;18(3):247-257. 12. Knipp DK. Teens' perceptions about attention deficit/hyperactivity disorder and medications. J Sch Nurs. 2006;22(2):120-5. 13. Bussing R, Koro-ljungberg M, Noguchi K, Mason D, Mayerson G, Garvan CW. Willingness to use ADHD treatments: a mixed methods study of perceptions by adolescents, parents, health professionals and teachers. Soc Sci Med. 2012;74(1):92-100. 14. Charach A, Yeung E, Volpe T, Goodale T, Dosreis S. Exploring stimulant treatment in ADHD: narratives of young adolescents and their parents. BMC Psychiatry. 2014;14:110. 15. Montano DE, Kaspryzk D. Health Behavior and Health Education: Theory, Research, and Practice. Jossey-Bass. Wiley Imprint. San Francisco, CA, 2008; Ed (4):69-96. 16. Horne, R., Weinman, J., Hankins, M. The beliefs about medicines questionnaire: The development and evaluation of a new method for assessing the cognitive representation of medication. Psychology and Health. 1999; 14, 1-24. 17. Fishbein, M. (ed.). Readings in Attitude Theory and Measurement. New York: Wiley, 1967. 18. Mccarthy S. Pharmacological interB2:K11ventions for ADHD: how do adolescent and adult patient beliefs and attitudes impact treatment adherence?. Patient Prefer Adherence. 2014;8:1317-27. 6 19. Bird HR, Andrews H, Schwab-Stone M. Columbia Impairment Scale (CIS). Global measures of impairment for epidemiologic and clinical use with children and adolescents. International Journal of Methods in Psychiatric Research. 1996;6(4):295–307. 20. American Academy of Pediatrics (AAP). Mental Health Screening and Assessment Tools for Primary Care: Assessing Child and Adolescent Functioning. https://www.aap.org/enus/advocacy-and-policy/aap-health-initiatives/mentalhealth/documents/mh_screeningchart.pdf. 2012. Accessed March 18, 2015. 21. Burns BJ, Angold A, Magruder-Habib K, Costello EJ, Patrick MKS. The Child and Adolescent Services Assessment (CASA): Child Interview. Developmental Epidemiology Program at the Department of Psychiatry and Behavioral Services. Duke University Medical Center. 2008; Version 5.0:1-67. 7 APPENDIX A (EMR Survey Data obtained by study representative) What year was the patient born in? What is the patient’sgender? Male Female What race or ethnicity is the patient identified as? Is the patient diagnosed with ADHD? Is the patient currently prescribed medication for ADHD? Is the patient taking any non-stimulant medications for ADHD treatment? How many stimulant medications is the patient taking for ADHD treatment? What stimulant medication is the patient prescribed for ADHD? (Check All that Apply, includes all controlled or sustained release forms) Methylin/Ritalin/Concerta/Metadate/Daytrana/Quillivant OR Methylphenidate Focalin OR Dexmethylphenidate Adderall OR Amphetamine Salts (Dextroamphetamine/Amphetamine) Dexedrine/DextroStat/Liquadd OR Dextroamphetamine Vyvanse OR Lisdexamphetamine Other Did the patient participate in behavioral therapy? How many times in the past 12 months has the patient been seen by their prescriber? 8 APPENDIX B (Patient Survey via Qualtrics) Patients were shown a page with a list of medications they might be taking and were asked to checkmark the box of the medication they used for ADHD, check the box if any in the row applied to them. Before moving on the patient must check a box understanding that the following survey was referring to ONLY the medication(s) they checked. List of medications included: Please select the box(es) which applies to you. If multiple in the same row apply please only select the box once. Select all boxes that apply. ___ Methylin/Ritalin/Concerta/Metadate/Daytrana/Quillivant OR Methylphenidate ___ Focalin OR Dexmethylphenidate ___ Adderall OR Amphetamine Salts (Dextroamphetamine/Amphetamine) ___ Dexedrine/DextroStat/Liquadd OR Dextroamphetamine ___ Vyvanse OR Lisdexamphetamine Questions (All questions answered on a 5-point likert scale 1-Stongly Disagree, 2-Disagree, 3Neurtral/Not Applicable, 4-Agree, 5-Stongly Agree) I feel like using stimulant medications to treat my ADHD was good for me. I feel like I should continue my ADHD medication. I would feel good about the idea of stopping my stimulant ADHD medication. If I could stop taking my stimulant ADHD medication I would. If I wanted to quit taking my stimulant ADHD medication today I could. My health at present depends on my stimulant ADHD medicines. My life would be impossible without my stimulant ADHD medicines. Without my ADHD medicines, I would be very ill. My health in the future will depend on my stimulant ADHD medicines. My stimulant ADHD medicines protect me from becoming worse. 9 APPENDIX C (Included in the Qualtrics electronic survery, Columbia Impairment Scale: youth version) Please choose the number which you think best describes your situation for each question (0No problem, 1-Little problem, 2-Some problem, 3-Significant problem, 4-Very bad problem, 5Not applicable/Don’t know): In general how much of a problem do you think you have with: 1) 2) 3) 4) …getting in trouble? …getting along with friends? …getting along with father/father figure? …feeling unhappy or sad? How much of a problem would you say you have: 5) …with your behavior at school? 6) …with having fun? 7) …getting along with adults other than your parents/guardians? How much of a problem do you have: 8) …with feeling nervous or afraid? 9) …getting along with your sister(s) and/or brother(s)? 10) …getting along with others your age? How much of a problem would you say you have: 11) …getting involved in activities like sports or hobbies? 12) …with your school work? 13) …with your behavior? 10