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Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians.

ABSTRACT: BACKGROUND:The degree of ADHD-related difficulties - reflecting overall impairment, social functioning, and quality of life - may be perceived differently by adolescent patients, parents and physicians. The primary aim of this study was to investigate ADHD-related difficulties during atomoxetine treatment, as perceived by the three different raters. Secondary objectives focused on effectiveness and tolerability of atomoxetine treatment in a population of adolescent patients with ADHD. METHODS:Adolescents with ADHD, aged 12-17 years, received open-label atomoxetine (0.5-1.2 mg/kg/day) up to 24 weeks. ADHD-related difficulties at various times of the day were rated using the Global Impression of Perceived Difficulties (GIPD) instrument. Inter-rater agreement was analyzed using Cohen's Kappa with 95% confidence intervals (95% CI). ADHD-Rating Scale (ADHD-RS) and Clinical Global Impression Severity (GGI-S) scores were assessed by the investigator; and spontaneous adverse events, vital signs and laboratory parameters were collected for tolerability assessments. RESULTS:159 patients received atomoxetine. Patients' baseline mean GIPD total ratings were significantly lower than parents' and physicians' scores (12.5 [95%CI 11.6;13.5] vs. 17.2 [16.2;18.2] and 18.8 [17.8;19.8]). For all raters, GIPD scores significantly improved over time. Changes were greatest within the first two weeks. Kappa coefficients varied between 0.186 [0.112;0.259] and 0.662 [0.529;0.795], with strongest agreements between parent and physician assessments, and significant improvements of patient/physician agreements over time (based on 95% CIs). ADHD-RS and CGI-S scores significantly improved over the course of the study (based on 95% CIs). Tolerability results were consistent with earlier reports. CONCLUSION:ADHD-related difficulties were perceived differently by the raters in this open-label trial, but consistently improved during atomoxetine treatment. The GIPD instrument appeared sensitive to treatment-related change. These primarily quantitative findings may guide future studies to more systematically investigate the clinical and practical relevance of the differences observed. Additionally, in order to further validate these results, placebo- and comparator-controlled trials are recommended as well as inclusion of healthy controls and other patient populations. TRIAL REGISTRATION: CLINICAL TRIAL REGISTRY:ClinicalTrials.gov: NCT00191737.

SUBMITTER: Dittmann RW

PROVIDER: S-EPMC2746185 | biostudies-literature | 2009 Aug

REPOSITORIES: biostudies-literature

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Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians.

Dittmann Ralf W RW Wehmeier Peter M PM Schacht Alexander A Minarzyk Anette A Lehmann Martin M Sevecke Kathrin K Lehmkuhl Gerd G

Child and adolescent psychiatry and mental health 20090824 1

<h4>Background</h4>The degree of ADHD-related difficulties - reflecting overall impairment, social functioning, and quality of life - may be perceived differently by adolescent patients, parents and physicians. The primary aim of this study was to investigate ADHD-related difficulties during atomoxetine treatment, as perceived by the three different raters. Secondary objectives focused on effectiveness and tolerability of atomoxetine treatment in a population of adolescent patients with ADHD.<h4 ...[more]

PMID: 19703299

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Project description:OBJECTIVE:This meta-analysis examined suicide-related events in the acute phases of double-blind, placebo-controlled atomoxetine trials in pediatric and adult patients with attention-deficit/hyperactivity disorder (ADHD). METHODS:A total of 3883 pediatric and 3365 adult patients were included. Potential events were identified from the adverse events database using a text-string search. Mantel-Haenszel risk ratios (MHRR) were calculated for potential suicide-related events categorized according to United States Food and Drug Administration defined codes. RESULTS:In this data set, no completed suicides were reported in the pediatric or adult populations. One pediatric (attempted suicide) (and no adult patient events) was categorized as suicidal behavior in the atomoxetine group. The frequency of combined suicidal behavior or ideation with atomoxetine treatment was 0.37% in pediatric patients (vs. 0.07% with placebo) and 0.11% in adults (vs. 0.12% with placebo) and the risk compared with placebo was not statistically significant (MHRR=1.57; p=0.42 and MHRR=0.96; p=0.96, respectively). In pediatric patients, suicidal ideation only was reported more frequently compared with placebo (MHRR=1.63; p=0.41). CONCLUSIONS:Overall in this data set, no completed suicides and 1 pediatric patient suicidal behavior event were reported in atomoxetine-treated pediatric and adult patients. Suicidal ideation was uncommon among atomoxetine-treated pediatric and adult patients, although it was reported more frequently in atomoxetine-treated pediatric patients compared with placebo; the reporting rate difference was not statistically significant. The MHRR of suicidal ideation was consistent with a previous meta-analysis of similar design. There was no evidence of increased risk for suicidal behavior in atomoxetine-treated pediatric or adult patients. CLINICAL TRIAL REGISTRATION INFORMATION:http://www.clinicaltrials.gov . The data reported are from an analysis of 23 pediatric and 9 adult clinical trials completed between 1998 and 2011. Ten pediatric (Studies HFBD, HFBK, LYAC, LYAS, LYAT, LYAW, LYAX, LYBG, LYBI, and LYBP) and two adult trials (Studies LYAA and LYAO) were conducted before the requirement to post trials at initiation (ongoing as of July 1, 2005) and, therefore, do not have a registration number. The registration numbers for the 13 pediatric trials meeting this requirement are: NCT00191698 (LYBX), NCT00486122 (LYCC), NCT00386581 (LYCZ), NCT00485459 (S010), NCT00191542 (LY15), NCT00191295 (LYBC), NCT00191906 (LYCK), NCT00192023 (LYCY), NCT00191945 (LYDM), NCT00546910 (LYDV), NCT00406354 (LYDW), NCT00380692 (S017), and NCT00607919 (LYEB). For the seven adult trials, the registration numbers are: NCT00190931 (LYBV), NCT00190957 (LYBY), NCT00190736 (LYCU), NCT00190775 (LYCW), NCT00190879 (LYDQ), NCT00510276 (LYDZ), and NCT00962104 (LYEE).

Project description:BackgroundEmpathy is a fundamental humanistic component of patient care which facilitates efficient and patient-centered clinical encounters. Despite being the principal recipient of physician empathy little work on how patients perceive/report receiving empathy from their physicians has been undertaken. In the context of doctor-patient interactions, knowledge about empathy has mostly originated from physicians' perspectives and has been developed from studies using self-assessment instruments. In general, self-assessment may not correlate well with the reality observed by others.ObjectivesTo investigate: 1-the relationship between physicians' self-assessed empathy and patients' measures of physicians' empathy; 2 -Environmental factors that could influence patients' perceptions; and 3 -the correlation between two widely used psychometric scales to measure empathy from the perspective of patients.MethodsThis is an observational study which enrolled 945 patients and 51 physicians from radiology, clinical, and surgical specialties. The physicians completed the Jefferson Scale of Physician Empathy (JSE) and the International Reactivity Index (IRI), and patients completed the Consultation and Relational Empathy scale (CARE), and the Jefferson Scale of Patient's Perceptions of Physician Empathy (JSPPPE).ResultsWe did not observe any significant correlation between total self-assessed empathy and patients' perceptions. We observed a small correlation (r = 0,3, P<0,05) between the sub-dimension Perspective Taking-JSE and JSPPPE. JSPPPE and CARE had a positive and moderate correlation (0,56; p<0,001). Physicians' gender and sector influenced the JSPPPE score. Sector, medical specialty and the nature of the appointment (initial versus subsequent) influenced the CARE measure.ConclusionsThe lack of correlation between self-assessed empathy levels and patients' perceptions suggests patients be included in the process of empathy evaluation.Practice implicationsTraining strategies aiming the development of empathy should include patients' evaluations and perspectives.

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Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians.

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Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians.

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