Weiss Functional Impairment Rating Scale-Parent Report Research Articles

Receiver operating characteristic curve analysis of the Weiss Functional Impairment Rating Scale-Parent Report for screening children with ADHD: Looking beyond symptoms in ADHD diagnosis.

The current study aimed at examining the ability of the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) to discriminate between children with ADHD and controls in functional impairment and identifying optimal cutoff scores for the WFIRS-P subscales and total scale. Parents of 51 children with ADHD (90.2% male; grades 1-6) and 51 gender/grade matched controls (90.2% male; grades 1-6) completed the WFIRS-P. Receiver operating characteristic (ROC) curve analysis was used to examine the ability of the WFIRS-P to differentiate children with ADHD from controls and to determine optimal cutoff scores of the WFIRS-P. Area under the curve (AUC) was 0.98 for the WFIRS-P total scale, indicating excellent ability to differentiate children with ADHD from controls. The score of 0.45 with 0.88 for sensitivity and 0.96 for specificity was determined as the optimal cutoff score for the total scale of the WFIRS-P. AUC was 0.73 to 0.97 for the WFIRS-P subscales, suggesting good to excellent ability for discriminating between children with ADHD and controls. Among the subscales, the family subscale score of 0.42 with 0.92 for sensitivity and 0.96 for specificity showed the highest discriminating power. The self-concept and life skills subscales had low sensitivity, suggesting Iranian mothers do not identify problems with self-concept or difficulty with life skills as particularly problematic in ADHD. The WFIRS-P is a sensitive and specific measure of the functional impairment associated with ADHD in Iranian children. Our sample was predominantly male, limiting the generalizability of results to females.

Identifying subgroups of attention-deficit/hyperactivity disorder from the psychopathological and neuropsychological profiles.

The Research Domain Criteria (RDoC) advocates the dimensional approach in characterizing mental disorders. We followed RDoC to characterize children with ADHD using profiling based on the cognitive and psychopathological domains. We aimed to identify and validate ADHD subtypes with different clinical characteristics and functional impairments. We recruited 362 drug-naïve children with ADHD and 103 typically developing controls. The cluster analysis was used to identify subgroups based on the Child Behaviour Checklist (CBCL) and the Behaviour Rating Inventory of Executive Function (BRIEF). The subgroups' clinical characteristics and functional impairments were assessed using the WEISS Functional Impairment Rating Scale-Parent Report (WFIRS-P) and the Conners Parent Symptom Questionnaire (PSQ). The cluster analysis yielded four subgroups: (1) ADHD with severe impairment in psychopathology and executive functions (EF), (2) ADHD with mild executive dysfunctions and normal-level psychopathology, (3) ADHD with severe externalizing problems and (4) ADHD with severe executive dysfunctions. These subgroups showed different clinical characteristics and degrees of functional impairment. The EF impairment group displayed more serious learning problems and worse life skills than the externalizing group. The two groups with externalizing problems (i.e. the severe impairment group and the externalizing group) both exhibited higher rates of the combined subtype of ADHD and higher rates of comorbid ODD. Different subtypes of ADHD displayed different profiles of internalizing and externalizing problems and levels of executive dysfunctions. In particular, the subtype with severe impairment in EF exhibited more learning problems and worse life skills, suggesting EF is a critical target for intervention in children with ADHD.

Response of peer relations and social activities to treatment with viloxazine extended-release capsules (Qelbree® ): A post hoc analysis of four randomized clinical trials of children and adolescents with attention-deficit/hyperactivity disorder.

Attention-deficit/hyperactivity disorder (ADHD) is associated with impairments related to peer relations (PR) and social activities (SA). The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves clinical assessments of PR and SA in children and adolescents with ADHD. Data were used from four Phase III placebo-controlled trials of 100 to 600mg/day of viloxazine ER (N=1354; 6-17 years of age). PR and SA were measured with the Peer Relations content scale of the Conners 3rdEditionParent Short Form'sPeerRelationcontentscale (C3PS-PR) and the Social Activities domain of the Weiss Functional Impairment Rating Scale-ParentReport's(WFIRS-P-SA) at baseline and end of study. ADHD symptoms were assessed weekly with the ADHD Rating Scale, 5th Edition. The analyses relied on the general linear mixed model with the subject as a random effect. Improvement in C3PS-PR (p=.0035) and WFIRS-P-SA (p=.0029) scores were significantly greater in subjects treated with viloxazine ER compared with placebo. When using measures of clinically meaningful response, the C3PS-PR responder rate was significantly higher for viloxazine ER (19.2%) compared with placebo (14.1%) and the difference was statistically significant (p=.0311); the Number Needed to Treat (NNT) was 19.6. The WFIRS-P-SA responder rate was significantly higher for viloxazine ER (43.2%) compared with placebo (28.5%) and the difference was statistically significant (p<.0001); the NNT was 6.8. The standardized mean difference effect size for both PR and SA was 0.09. Viloxazine ER significantly reduces the impairment of PR and SA in children and adolescents with ADHD. Although its effects on PR and SA are modest, many ADHD patients can be expected to achieve clinically meaningful improvements in PR and SA with viloxazine ER treatment for longer than 6 weeks.

Validation of the Weiss Functional Impairment Rating Scale (WFIRS-P) as a Functional Impairment Measure in a General Population of Schoolchildren.

Functional impairment rating scales are few in numbers and have mainly been examined in clinical populations. The Weiss Functional Impairment Rating Scale-Parent report (WFIRS-P) is a case in point. We tested the psychometric properties of the WFIRS-P in the largest general population study to date and for the first time examined the factor structure of the scale in a general population setting. Participants were 2,027 schoolchildren aged 6 to 11. Parents/caregivers completed the WFIRS-P and criterion measures of quality of life, attention-deficit/hyperactivity disorder, and behavioral/emotional symptoms. Confirmatory factor analysis and convergent/divergent validity analyses supported a six-factor structure: family, life skills, self-concept, social activities, and the separation of the school domain into two smaller domains covering school learning and school behavior. Children with and without a history of referral differed significantly on all six domains supporting the external validity. In conclusion, the WFIRS-P was found to generate valid scores in a general population sample.

Functional outcomes of extended-release methylphenidate and atomoxetine in children: retrospective chart analysis

BackgroundRecent guidelines emphasize the importance of functional outcomes in children with attention-deficit/hyperactivity disorder (ADHD). Here, we assess the functional outcomes of the oral delivery system of osmotic-release methylphenidate (OROS-MPH) and atomoxetine (ATX) from the retrospective review of the chart for the last 2 years in the clinic.ResultsLinear mixed-effects models were performed with outcome measures of difference in ADHD symptoms and functional impairment. After 9–12 weeks, OROS-MPH and ATX were statistically equivalent for total Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) scores (difference in slope is β = 0.004, p = 1.000). However, OROS-MPH was superior to ATX in terms of school domain (difference in slope is β = 0.139, p < 0.001); ATX was superior in the family domain (slope difference in slope is β = 0.103, p < 0.001). The other domains of functioning both were not responsive to pharmacotherapy and were similar between the two medications.ConclusionsOptimal management should monitor functional progress in ADHD beyond the core symptoms. As expected, ADHD medications provide a distinct pattern of functional improvement. Pharmacotherapy alone offers promising and reliable outcomes to improve school and family functions in ADHD. Some functional improvements did not respond to the medication; therefore, many of the techniques derived from behavioral interventions should be considered.

Functional impairment outcomes in clinical trials of different ADHD medications: post hoc responder analyses and baseline subgroup analyses

Several recent phase 3 clinical trials of attention-deficit/hyperactivity disorder (ADHD) medications have used the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P). Here, we assess WFIRS-P response in individual patients in two pivotal trials of lisdexamfetamine dimesylate (LDX) and guanfacine extended release (GXR). We also analysed pooled WFIRS-P data from seven phase 3 studies of ADHD medications to shed light on factors associated with baseline functional impairment. The proportion of patients with a change in WFIRS-P score that exceeded the minimal important difference (MID) criteria for response was greater for LDX than placebo in the Family, Learning and School, and Risky Activities domains, and was greater for GXR than placebo in the Social Activities, Learning and School, and Family domains. Responders had significantly worse baseline scores in all WFIRS-P domains (all p < 0.001) than non-responders. In the pooled analyses, baseline WFIRS-P scores in all domains were significantly worse in participants with oppositional defiant disorder (ODD) than in those without ODD. Having combined type or hyperactive-impulsive type ADHD, being enrolled into a study in Europe, being male and being younger also had modest negative effects on baseline WFIRS-P scores. The present analysis of WFIRS-P response shows that previously reported group-level improvements in WFIRS-P functional impairment score translated into clinically relevant improvements in many individual participants. Functional impairment is a diverse and subjective construct that is influenced by multiple factors. Optimal management of individuals with ADHD should involve monitoring improvements in functioning and quality of life, as well as symptomatic improvement.

Restless legs syndrome in children and adolescents with attention-deficit/hyperactivity disorder: prevalence, mimic conditions, risk factors, and association with functional impairment

ObjectivesTo determine the prevalence of restless legs syndrome (RLS) and RLS-mimic conditions, the risk factors for RLS, and whether RLS contributes to functional impairment in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). MethodsADHD children and adolescents were prospectively studied at the outpatient psychiatric clinic. A trained registered nurse used the 2012 Revised International Restless Legs Syndrome Study Group diagnostic criteria to diagnose RLS. Sociodemographic data and medical records were reviewed. Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) Thai version was used to identify association between RLS and 6 domains of function [family, school (learning), school (behavior), life skills, child self-concept, social activities, and risky activities]. ResultsA total of 217 patients were included. Of those, 23 (11%) patients met the criteria for RLS, and 49 (23%) had RLS-mimic conditions. Those conditions included myalgia (30/49), habitual foot tapping (23/49), positional discomfort (20/49), leg ulcer/bruise (1/49), and arthralgia/arthritis (1/49). Binary logistic regression revealed first-degree relative having RLS symptom to be significantly associated with RLS in study patients (OR: 5.06, p < 0.01). Multivariate linear regression showed RLS to be independently associated with school (behavior) (Β = 1.18, p = 0.05) and life skills (Β = 2.36, p = 0.05) impairment. ConclusionsRLS was found to be common in ADHD children and adolescents. RLS-mimic conditions were found in two-thirds of patients who previously met 4 essential RLS criteria. First-degree relative with RLS symptom was associated with RLS, and RLS was associated with functional impairment in the life skills and school (behavior) domains.

Attention and behavioral control skills in Iranian school children

This study assessed quality of life, emotional and behavioral problems, prosocial behavior, and functional impairment in a sample of Iranian children based on their attention and behavioral control skills. The sample consisted of 280 male and female children aged between 6 and 12years old who were divided into strong, moderate, and weak groups based on parental ratings of attention and behavioral control skills on the strengths and weaknesses of ADHD symptom and normal behavior rating scale (SWAN). In addition, parents completed the pediatric quality of life inventory version 4.0 generic core scales (PedsQL 4.0), the strengths and difficulties questionnaire, and the Weiss functional impairment rating scale-parent report (WFIRS-P). The strong group generally showed better quality of life than the weak group. The strong group was better than the moderate group, and the moderate group was better than the weak group on school functioning. The weak group had more conduct problems and hyperactivity/inattention and less prosocial behavior than the moderate group and the strong group. The moderate group had more hyperactivity/inattention than the strong group. The weak group showed more impairment than the moderate group and the strong group on all subscales and the total scale of the WFIRS-P. The quality of life, behavioral problems, prosocial behavior, and functional impairment can be different in children based on their attention and behavioral control skills.

Psychometric properties of a modified version of the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) in a clinical sample of children with aggressive behavior

To evaluate the psychometric properties of a German modification of the Weiss Functional Impairment Rating Scale-Parent Report for children with aggressive and oppositional behavior problems (WFIRS-P for ODD/CD). Data were collected from a clinical sample of children (6-12 years; 96% boys) with oppositional defiant disorder (ODD) and conduct disorder (CD) (N = 219). The WFIRS-P conceptual framework was evaluated using confirmatory factor analyses (CFA). Reliability was estimated using internal consistency (Cronbach's alpha) and omega statistics. Validity was assessed through correlations between WFIRS-P for ODD/CD domain scores and parent-rated scales on symptoms of ODD, CD, attention-deficit/hyperactivity disorder (ADHD), a broad range of other behavioral and emotional problems, and scales on health-related quality of life and family burden. CFA of the WFIRS-P for ODD/CD revealed that a bifactor model, with a general factor accounting for common variance (ωH = 0.23-0.48) and independent specific group factors accounting for additional variance in item scores (ωS = 0.37-0.60), best fits the data. Thus, CFA confirmed the theoretical assumption of a general construct of impairment (total scale) and additional specific impairments (subscales, e.g., family, social activities). Cronbach's alpha coefficient exceeded 0.70 for all subscales. Omega statistics showed that both the general construct and specific factors accounted for item variance. As expected, correlations with symptoms scales for ODD/CD and ADHD were low to moderate. The use of the parent-rated WFIRS for ODD/CD in identifying ODD- and CD-related impairment in children is psychometrically supported. The scale can be employed to assess functional impairment in children with aggressive behavior problems.

Estimating minimal important differences for several scales assessing function and quality of life in patients with attention-deficit/hyperactivity disorder.

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. 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. At follow-up, a subset of parents completed anchor questions measuring change in the child/adolescent from baseline. MIDs were estimated using anchor-based and distribution-based methods, and separately for children and adolescents. The MID estimates for overall change in the WFIRS-P total score ranged from 11.31 (standard error of measurement) to 13.47 (anchor) for the total sample. The range of MID estimates for the CHIP-CE-PRF76 varied by domain: 6.80-7.41 (satisfaction), 6.18-7.34 (comfort), 5.60-6.72 (resilience), 6.06-7.57 (risk avoidance), and 4.00-5.63 (achievement) for the total sample. Overall, MID estimates for WFIRS-P MID and CHIP-CE-PRF76 were slightly higher for adolescents than for children. This study estimated MIDs for these instruments using several methods. The observed convergence of the MID estimates increases confidence in their reliability and could assist clinicians and decision makers in deriving meaningful interpretations of observed changes in the WFIRS-P and CHIP-CE in clinical trials and practice.

Functional Impairment in Children With Externalizing Behavior Disorders: Psychometric Properties of the Weiss Functional Impairment Rating Scale–Parent Report in a German Clinical Sample

Objective: To examine the psychometric properties of a German adaptation of the Weiss Functional Impairment Rating Scale–Parent Report (WFIRS-P) in a clinical sample of children (4-12 years) with externalizing behavior disorders. Method: Data were collected within two clinical trials (N = 264). Factorial validity, reliability, and divergent validity from symptoms of ADHD and oppositional defiant disorder (ODD) were assessed. Results: Confirmatory factor analyses revealed that a bifactor model consistent with the theoretical assumption of a general construct of impairment (total scale) and additional specific factors (subscales) provided satisfactory data fit. Model-based reliability estimates showed that both the general construct and specific factors accounted for item variance. Internal consistencies were >.70, part–whole corrected item–scale correlations mostly >.30. Correlations between the WFIRS-P Scales and ADHD and ODD symptoms were low to moderate. Conclusion: The results support the factorial validity, reliability, and divergent validity of the WFIRS-P.

Does Guanfacine Extended Release Impact Functional Impairment in Children with Attention-Deficit/Hyperactivity Disorder? Results from a Randomized Controlled Trial.

BackgroundIn clinical trials of medications to treat attention-deficit/hyperactivity disorder (ADHD) in children, effects on functional impairment have been less well-studied than changes in ADHD symptoms.ObjectiveData regarding functional impairment were analyzed from a multicenter, double-blind, placebo-controlled study of guanfacine extended release (GXR) in children with ADHD, using the Weiss Functional Impairment Rating Scale–Parent Report (WFIRS-P). The correspondence of changes in WFIRS-P scores with symptomatic and global response to GXR treatment was also examined, with treatment response defined by scores on both the ADHD Rating Scale IV (ADHD-RS-IV) and the Clinical Global Impressions–Improvement Scale (CGI-I).MethodsIn this 8-week, double-blind, placebo-controlled, dose optimization study at 47 sites across the USA and Canada, children aged 6–12 years with a diagnosis of ADHD [Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision criteria, and an ADHD-RS-IV score ≥28 and CGI–Severity of Illness Scale score ≥4 at baseline], were randomized 1:1:1 into three groups: GXR am [GXR (1–4 mg/day) in the morning, placebo in the evening], GXR pm [placebo in the morning, GXR (1–4 mg/day) in the evening], or twice-daily placebo. Parents rated their children on the WFIRS-P at screening, baseline, the end of dose optimization, and at the final on-treatment assessment.ResultsThe efficacy population was composed of 333 subjects (GXR am: n = 107; GXR pm: n = 114; placebo: n = 112). At the final on-treatment assessment, there were significant improvements from baseline in the placebo-adjusted difference in least-squares (LS) mean (95 % confidence interval) WFIRS-P Total scores for both GXR treatment groups combined [GXR all-active: −0.16 (−0.25, −0.07), effect size (ES) = 0.448, P <0.001] and separately [GXR am: −0.15 (−0.26, −0.05), ES = 0.417, P = 0.004; GXR pm: −0.18 (−0.28, −0.07), ES = 0.478, P = 0.001]. Significant improvements in WFIRS-P domain scores for Family, Learning and School (including Academic Performance and Behavior in School), Social, and Risky Behavior were found for both GXR cohorts compared with placebo. However, the Life Skills and Self-Concept domain scores of the WFIRS-P did not improve with GXR treatment. Post hoc stratification by responder status revealed that significant (P <0.001) improvements in WFIRS-P Total and all domain scores were associated with symptomatic treatment response in the GXR all-active group.ConclusionsGXR treatment in children with ADHD was associated with reductions in WFIRS-P functional impairment scores compared with placebo, regardless of time of GXR administration. Changes in WFIRS-P scores were congruent with clinical response, as determined by both ADHD symptom reduction and CGI-I scores.ClinicalTrials.gov identifierNCT00997984.

A Randomized, Placebo-Controlled Trial of Guanfacine Extended Release in Adolescents With Attention-Deficit/Hyperactivity Disorder

Despite the continuity of attention-deficit/hyperactivity disorder (ADHD) into adolescence, little is known regarding use of nonstimulants to treat ADHD in adolescents. This phase 3 trial evaluated the safety and efficacy of guanfacine extended release (GXR) in adolescents with ADHD. This 13-week, multicenter, randomized, double-blind, placebo-controlled trial evaluated once-daily GXR (1-7 mg per day) in adolescents with ADHD aged 13 to 17 years. The primary endpoint was the change from baseline in the ADHD Rating Scale-IV (ADHD-RS-IV) total score; key secondary endpoints included scores from the Clinical Global Impressions-Severity of Illness (CGI-S), and Learning and School domain and Family domain scores from the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at week 13. A total of 314 participants were randomized (GXR, n = 157; placebo, n = 157). The majority of participants received optimal doses of 3, 4, 5, or 6 mg (30 [22.9%], 26 [19.8%], 27 [20.6%], or 24 [18.3%] participants, respectively), with 46.5% of participants receiving an optimal dose above the currently approved maximum dose limit of 4 mg. Participants receiving GXR showed improvement in ADHD-RS-IV total score compared with placebo (least-squares mean score change, -24.55 [GXR] versus -18.53 [placebo]; effect size, 0.52; p <.001). More participants on GXR also showed significant improvement in CGI-S scores compared with placebo (50.6% versus 36.1%; p = .010). There was no statistically significant difference between treatments at week 13 in the 2 WFIRS-P domains. Most treatment-emergent adverse events were mild to moderate, with sedation-related events reported most commonly. GXR was associated with statistically significant improvements in ADHD symptoms in adolescents. GXR was well tolerated, with no new safety signals reported. Dose-Optimization in Adolescents Aged 13-17 Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD) Using Extended-Release Guanfacine HCl; http://ClinicalTrials.gov/; NCT01081132.

Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.

Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients’ lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6–17 years with an ADHD Rating Scale IV total score ≥28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95 % confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of −0.35 (95 % CI −0.42, −0.29) for LDX and −0.27 (−0.33, −0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.Electronic supplementary materialThe online version of this article (doi:10.1007/s00787-015-0718-0) contains supplementary material, which is available to authorized users.

CHILDREN ATTENTION DEFICT HYPERACTIVITY DISORDER

Objective: To determine the frequency of functional impairment in the domainof “school and learning” among school going age children with ADHD. Study Design: Crosssectionalstudy. Setting: Neuropsychiatry OPD at National Institute of Child Health (NICH),Karachi. Period: April 2012 to October 2012. Methodology: A total 122 child and adolescentpatients of school going age i.e. 05-15 years diagnosed as having ADHD were included in thestudy. A Proforma was used to denote demographic details of the patients. Impairment in thedomain of “school and learning” was measured by using the Weiss Functional ImpairmentRating Scale – Parent Report (WFIRS-P). Results: of the total 122 patients 74% were malesand 26% were females. 61% were studying in primary school whereas 28% either never wentto school or had quit school. overall the domain of school and learning was impaired in about48% of children with females’ representation being slightly more (50%) compared to males(46%). within the domain of school and learning maximum number of children were impairedin keeping up with schoolwork and needing tutoring (61%); whereas the least frequency ofimpairment was observed in being suspended or expelled from school (30%). Conclusions:ADHD causes functional impairment among children of school going age in the domain ofschool and learning.

Turkish validity and reliability study of the Weiss Functional Impairment Rating Scale-Parent Report.

Attention deficit hyperactivity disorder (ADHD) is seen frequently in childhood and leads to marked impairment in functioning. There is no scale in Turkey with documented validity and reliability that assesses ADHD-specific functional impairment (FI). This study aimed at adapting the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), which assesses ADHD-related FI, for use in Turkey, and examining psychometric aspects of the scale. The study included 250 children diagnosed with ADHD and 250 healthy children and their parents. Internal consistency and test-retest methods were used to test the reliability of the scale. Validity was tested with exploratory and confirmatory factor analyses and convergent and discriminant validity analyses. Since all six questions of the WFIRS-P were scored 0, analyses were conducted for the original scale questionnaire consisting of 50 items and the questionnaire consisting of 44 items where the six questions scored 0 were not included. The Cronbach's alpha coefficient was 0.93 for the whole scale. The Spearman's correlation coefficient was 0.93 for test-retest reliability. The exploratory factor analysis run on the 44-item questionnaire showed that the scale items were best represented in a 7-factor structure, but some items were placed in different subdomains than those of the original scale. In the confirmatory factor analysis, the root mean square error of approximation was 0.061, and the comparative fit index was 0.95 for the whole model. Therefore, the Turkish WFIRS-P is valid and reliable in testing functional impairment in children with ADHD.

EPA-0994 – Assessing adhd stimulant treatment efficacy using the weiss functional impairment rating scale: strengths and weaknesses

Introduction The Weiss Functional Impairment Rating Scale–Parent Report (WFIRS-P) is an ADHD-specific instrument comprising 50 items, grouped into six domains. Parents score each item on a Likert scale (0–3 or not applicable). Objective To evaluate functional impairment using the WFIRS-P in two phase 3 studies (SPD489-325 and SPD489-326) of lisdexamfetamine dimesylate (LDX) in children and adolescents with ADHD. Methods Patients’ parents or guardians completed WFIRS-P assessments at baseline, and weeks 4 and 7 of SPD489-325, a 7-week, randomized, placebo controlled trial incorporating a reference treatment (osmotic-release oral system methylphenidate; OROS-MPH). Statistical comparison of LDX versus OROS-MPH was not pre-specified. In SPD489-326, WFIRS-P assessments were performed in the ≥26-week open-label period and the subsequent 6-week randomized-withdrawal period. Results In SPD489-325, statistically significant placebo-adjusted effects of LDX were observed in WFIRS-P total score (effect size, 0.924; p p p Conclusions Short-term treatment with LDX or OROS-MPH led to improved functional impairment scores. These benefits were maintained during long-term LDX treatment, and scores declined following treatment withdrawal. Supported by funding from Shire .

Health-Related Quality of Life and Functional Outcomes from a Randomized, Controlled Study of Lisdexamfetamine Dimesylate in Children and Adolescents with Attention Deficit Hyperactivity Disorder

BackgroundOptimal management of attention deficit hyperactivity disorder (ADHD) aims not only to ameliorate patients’ symptoms, but also to improve health-related quality of life (HRQL) and functioning. A pivotal, 7-week, randomized, double-blind, placebo-controlled, phase III study in children and adolescents in ten European countries demonstrated that the stimulant prodrug lisdexamfetamine dimesylate (LDX) is an effective and generally well-tolerated treatment for symptoms of ADHD.ObjectiveThe aim of this study was to assess HRQL and functional impairment outcomes in this clinical trial, using the Child Health and Illness Profile-Child Edition: Parent Report Form (CHIP-CE:PRF) and the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P), respectively.MethodsPatients (aged 6–17 years) with diagnosed ADHD and a baseline ADHD Rating Scale IV total score ≥28 were randomized (1:1:1) to 7 weeks of double-blind treatment with once-daily LDX, placebo or the reference treatment, osmotic-release oral system methylphenidate (OROS-MPH). Participants’ parents (or legally authorized representatives) completed the CHIP-CE:PRF and WFIRS-P questionnaires at baseline, at weeks 4 and 7, and/or at early termination. Endpoint was defined as the last on-treatment visit with valid data (≤30 % missing items). The CHIP-CE:PRF Achievement domain was pre-specified as the primary HRQL outcome.ResultsThe full analysis set comprised 317 patients (LDX, n = 104; placebo, n = 106; OROS-MPH, n = 107), the majority of whom completed the study (LDX, n = 77; placebo, n = 42; OROS-MPH, n = 72). Baseline CHIP-CE:PRF T-scores in four of the five domains were ≥1 standard deviation below norms (US community samples). Compared with placebo, LDX was associated with statistically significantly improved T-scores from baseline to endpoint in these four domains, with effect sizes of 1.280 (p < 0.001) in Achievement, 1.079 (p < 0.001) in Risk Avoidance, 0.421 (p < 0.01) in Resilience and 0.365 (p < 0.05) in Satisfaction. In LDX-treated patients, placebo-adjusted improvements from baseline to endpoint in WFIRS-P scores were statistically significant (p < 0.001) for total score and four of the six domains, with effect sizes of 0.924 (total score), 1.249 (Learning and School), 0.730 (Family), 0.643 (Social Activities) and 0.640 (Risky Activities). OROS-MPH treatment showed similar patterns of improvement from baseline to endpoint in both CHIP-CE:PRF and WFIRS-P scores.ConclusionsBaseline HRQL and functional impairment scores reflect the burden of untreated ADHD. The benefits of short-term stimulant treatment in children and adolescents with ADHD extend beyond symptomatic relief and impact positively on HRQL and daily functioning.Electronic supplementary materialThe online version of this article (doi:10.1007/s40263-013-0095-5) contains supplementary material, which is available to authorized users.

Atomoxetine and Neuropsychological Function in Children With Attention-Deficit/Hyperactivity Disorder: Results of a Pilot Study

This pilot longitudinal study using measures from parents and teachers evaluated the effects of flexible doses of atomoxetine (ATX) on neuropsychological and functional outcomes in 21 children with attention-deficit/hyperactivity disorder (ADHD) (mean age, 8.0 +/- 1.3 years; inattentive subtype, 71.4%; combined subtype, 28.6%). Among 16 children completing 6 months of ATX treatment, neuropsychological function measured by the NEPSY instrument found significant improvement from baseline in the memory and learning domain (p = 0.01); this change was also seen in an age- and sex-matched healthy control group (p = 0.011). The patient group showed significant improvement on the Test of Everyday Attention (TEA-Ch) and parent and teacher versions of the Behavior Rating Inventory of Executive Function (BRIEF), which assess attentional and executive processes, respectively. Functional improvement was also observed on the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) and parent and teacher versions of the ADHD Rating Scale (ADHDRS-IV), and the investigator-rated Clinical Global Impressions-Severity (CGI-S) scale evidenced reductions in ADHD symptoms. These findings suggest that potential benefits of ATX treatment may extend beyond reduction of core ADHD symptoms to amelioration of some neuropsychological and functional deficits.