ORIGINAL INVESTIGATION Correlation of symptomatic improvements with functional improvements and patient-reported outcomes in adults with attention-deficit/hyperactivity disorder treated with OROS methylphenidate MICHAEL RÖSLER 1 , YLVA GINSBERG 2 , TORBEN ARNGRIM 3 , MARIOS ADAMOU 4 , ASKO NIEMELÄ 5 , JOACHIM DEJONKHEERE 6 , JOOP VAN OENE 7 & BARBARA SCHÄUBLE 8 1 Saarland University Hospital, Neurocentre, Homburg/Saar, Germany, 2 Department of Clinical Neuroscience, Stockholm Centre for Psychiatric Research, Karolinska Institutet, Stockholm, Sweden, 3 Private Practice, Aarhus, Denmark, 4 Service for Adults with ADHD, South West Yorkshire Partnership NHS Foundation Trust, UK, 5 Wellmind Health Ltd, Oulu, Finland, 6 SGS Life Science Services, Mechelen, Belgium, 7 Formerly Janssen–Cilag Medical Affairs Europe, Middle East & Africa, Tilburg, The Netherlands, and 8 Janssen–Cilag Medical Affairs Europe, Middle East & Africa, Neuss, Germany Abstract Objectives. To evaluate correlations between symptom severity and daily functioning in adults with ADHD. Methods. In the 5-week, double-blind LAMDA study, 401 adults with ADHD were randomly assigned to Osmotic-Release Oral System (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo. The primary variable – investigator-rated Conners’ Adult ADHD Rating Scale (CAARS:O-SV) – has been presented previously. Secondary endpoints included the self- reported version of CAARS (CAARS-S:S) and Clinical Global Impression – Severity (CGI-S). Daily functioning and quality of life were assessed using the Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Relationships between symptom and functional outcomes were evaluated in post-hoc Pearson partial correlation, multivariate regression and mediator analyses. Results. Improvements in CAARS-S:S, CGI-S and SDS scores were significantly greater in each OROS MPH arm versus placebo ( P  0.01 for all comparisons). Correlations between symptom and functioning scores were significant for all comparisons ( P  0.0001). In regression analyses, CAARS Hyperactivity/Impulsivity subscale and CGI-S were correlated with SDS ( P  0.05). CAARS Inattention was correlated with the SDS Family Life domain ( P  0.05). In a mediator analysis, the impact of treatment on SDS scores was fully mediated by improvement in CAARS:O-SV score. Conclusions. OROS MPH 18–72 mg/day was associated with significant improvements in ADHD symptoms, which correlated with improved daily functioning and health-related quality of life. Key words: Adults, attention-deficit/hyperactivity disorder, daily functioning, OROS methylphenidate, health-related quality of life Introduction The importance of improving outcomes for persons with serious mental disorders is increasingly acknowl- edged, and outcomes are being conceptualized more broadly to include daily functioning. It is well docu- mented that adults with ADHD have substantial dif- ficulties with basic (personal care skills, social functioning) and instrumental (community living) aspects of daily functioning (Kessler et al. 2006). This in turn leads to impairment of education, daily respon- sibilities, work, money management, relationships, and social activities (Barkley et al. 2008). Moreover, adults with ADHD are more likely to make mistakes in social situations, or to act in ways viewed as inappropriate by others, which can affect many areas of life, such as family (Eakin et al. 2004) and work (Halmoy et al. 2009). Some adults with ADHD are also more likely to engage in antisocial behaviour (e.g., theft, assault, vandalism, carrying a weapon, posses- sion of illegal drugs or disorderly conduct) (Barkley et al. 2004; Biederman 2004; Biederman et al. 2006; Mannuzza et al. 2008) and to have been arrested, convicted and incarcerated (Babinski et al. 1999; Correspondence: Prof. Dr. Michael Rösler, Neurocentre, Saarland University Hospital, D-66421 Homburg/Saar, Germany; Tel: 49 68 41 16 26350. Fax: 49 68 41 16 26335. E-mail: michael.roesler@uks.eu (Received 4 November 2010; accepted 9 March 2011) The World Journal of Biological Psychiatry, 2013; 14: 282–290 ISSN 1562-2975 print/ISSN 1814-1412 online © 2013 Informa Healthcare DOI: 10.3109/15622975.2011.571283 World J Biol Psychiatry Downloaded from informahealthcare.com by Karolinska Institutet University Library on 06/01/13 For personal use only.