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Cited by 5Attention Deficit Hyperactivity DisorderPharmacology and Obesity TreatmentSchizophrenia research and treatment

Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder

Open access
Childress, Ann C., Cutler, Andrew J., Saylor, Keith, Gasior, Maria, Hamdani, Mohamed, Ferreira-Cornwell, M. Celeste, Findling, Robert L.·2014·Journal of Child and Adolescent Psychopharmacology
DOI 10.1089/cap.2013.0077PMC PMC4026374
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Abstract

OBJECTIVES: The purpose of this study was to assess long-term improvement in quality of life (QOL) in adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with lisdexamfetamine dimesylate (LDX). METHODS: Adolescents with ADHD treated for ≥3 weeks in a 4 week, placebo-controlled study entered a 1 year, open-label study. After the 4 week dose optimization (30, 50, and 70 mg/day LDX) period, treatment was maintained for 48 additional weeks. Change from baseline (of prior study) to week 52/early termination (ET) (of open-label study) in ADHD Rating Scale IV (ADHD-RS-IV) assessed effectiveness, and the Youth QOL-Research Version (YQOL-R) assessed participant-perceived QOL. Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline (≥1 SD below the mean) versus all others, and for study completers versus study noncompleters. RESULTS: These post-hoc analyses included 265 participants. Participants with baseline self-perceived poor QOL (n=32) versus all others (n=232) exhibited robust YQOL-R perceptual score changes (improvement) with LDX, emerging by week 28 and maintained to week 52/ET. Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others; week 52/ET improvements in ADHD-RS-IV total scores were similar, regardless of baseline YQOL-R total score. At week 52/ET, study completers had greater YQOL-R improvements than did noncompleters; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters. CONCLUSION: Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.

AI snapshot

Written from the paper’s full text.

TL;DR

In a post-hoc analysis of a 52-week open-label lisdexamfetamine dimesylate (LDX) extension in adolescents with ADHD (n=265), participant-perceived quality of life (QOL) and ADHD symptoms improved from baseline, with the greatest QOL gains among those with self-perceived poor QOL at baseline. QOL improvements were robust in the poor-QOL subgroup and modest in others, while ADHD-RS-IV improvements were similar regardless of baseline QOL.

Key findings

  • Among 265 participants, 32 had baseline self-perceived poor QOL (YQOL-R total perceptual score ≤1 SD below the mean) and 232 were categorized as others. Baseline mean (SD) YQOL-R total perceptual scores were 57.6 (9.84) for the poor-QOL group versus 82.8 (7.38) for others.
  • Week 52/ET mean change in YQOL-R total perceptual score was +12.5 (13.02) for the poor-QOL group versus +2.9 (8.72) for others; domain changes ranged from +9.8 to +17.6 versus +0.4 to +5.1. Week 28 changes were +17.6 (9.51) versus +3.0 (7.93).
  • ADHD-RS-IV total score improvements at week 52/ET were similar regardless of baseline YQOL-R total score. Study completers (n=156) had greater YQOL-R improvements than noncompleters (n=109): week 52/ET total change +5.0 (9.52) versus +1.9 (9.64); ADHD-RS-IV changes were also numerically larger for completers than noncompleters.
  • Overall population baseline YQOL-R total perceptual score was 79.8 (11.28), and week 52/ET was 83.9 (11.00); the authors note the overall change approached but did not reach the 0.5 SD minimally important difference threshold of approximately 5.5 points.

Methods

  • Post-hoc analysis of a 52-week, open-label, multicenter, single-arm extension trial. Adolescents with ADHD who completed ≥3 weeks of a prior 4-week placebo-controlled LDX trial entered; LDX doses of 30, 50, or 70 mg/day were optimized during weeks 1–4 and maintained for 48 additional weeks.
  • The full analysis set included 265 participants who had taken ≥1 dose of study medication and had ≥1 valid post-visit 1 ADHD-RS-IV assessment. The YQOL-R perceptual items (41 items; total and self, relationships, environment, and general domains) were assessed at baseline, week 28, and week 52/early termination (ET); ADHD-RS-IV assessed effectiveness.
  • Participants were stratified by baseline YQOL-R score (≤1 SD below the overall mean versus all others) and by study completion status. Week 52/ET changes were assessed with a two-sided one-sample t test; subgroup analyses were descriptive because the study was not powered to detect statistically significant differences among subgroups.

Limitations

  • Stated: the open-label design may introduce expectation bias; open-label extension participants were not randomized and likely tolerated or responded to prior treatment; parent-report QOL was not used; QOL was a secondary endpoint with limited planned analyses and post-hoc interpretation; the YQOL-R is not ADHD-specific; most participants reported only mild/moderate baseline QOL impairment, suggesting a ceiling effect; regression to the mean cannot be discounted.
  • Evident from the text: the extension had no placebo/control arm; the poor-QOL subgroup was small (n=32) and subgroup comparisons were descriptive and not powered; QOL was assessed at only four time points across the two trials, so the full time course of QOL improvement is unknown.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1089/cap.2013.0077

Cites

31 of 31 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

6 of 41 cited sources checked · 5 supported · 0 flagged · accuracy not yet measured

  • Premisecitation
    § Introduction

    A meta-analysis of five clinical trials of atomoxetine showed large baseline impairments in QOL among adolescents with ADHD, particularly in self-esteem, family involvement, and academic achievement.

    “A meta-analysis of five clinical trials (three randomized, double-blind, placebo-controlled trials; two open-label trials) of the nonstimulant medication atomoxetine (all treatment durations: 8–12 weeks) showed large baseline impairments in QOL among adolescents with ADHD when only placebo-controlled trials were assessed and when all trials were assessed (placebo-controlled+open-label); impairment”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites Wehmeier et al. 2010 source
  • Premisecitation
    § Introduction

    Decreased QOL among individuals with ADHD is well established.

    “Decreased QOL among individuals with ADHD is well established (Klassen et al. 2004; Topolski et al. 2004; Zambrano-Sanchez et al. 2012), with QOL negatively correlated with symptom severity (Klassen et al. 2004; Matza et al. 2004).”
    Quote in the paperNot a substantial claim1 of 3 sources checked
    • cites Klassen et al. 2004 source
    • cites Topolski et al. 2004 source
    • cites Zambrano-Sanchez et al. 2012 source
  • Findingown data
    § Abstract

    In adolescents with ADHD treated with lisdexamfetamine dimesylate in this 52-week open-label extension, participant-perceived quality of life (YQOL-R perceptual total score) improved from baseline to week 52/early termination.

    “Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.”
    • Also stated in: § Introduction · plain
      “In terms of effectiveness, mean change from baseline on ADHD-RS-IV total score with LDX at the end of the study was significant, as was the mean change from baseline on the transformed YQOL-R perceptual total score.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Findling et al. 2013 source
    • Rests on an assumption: The improvements in QOL and ADHD symptoms observed during open-label LDX treatment are attributable to LDX rather than to non-specific effects, open-label bias, or the natural course of ADHD.
  • Findingown data
    § Abstract

    The greatest participant-perceived QOL improvements with LDX occurred among adolescents with ADHD who had baseline self-perceived poor QOL.

    “Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.”
    • Also stated in: § Results · plain
      “With LDX treatment, those with self-perceived poor QOL exhibited numerically greater change in transformed YQOL-R total perceptual score at all time points assessed (ranging from 12.5 to 17.6) than those categorized as others (2.9–3.8) (Table 1).”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The improvements in QOL and ADHD symptoms observed during open-label LDX treatment are attributable to LDX rather than to non-specific effects, open-label bias, or the natural course of ADHD.
    • Rests on an assumption: The improvements in QOL among participants selected for low baseline YQOL-R scores are not due to regression to the mean.
  • Findingown data
    § Abstract

    In adolescents with ADHD treated with lisdexamfetamine dimesylate in this 52-week open-label extension, ADHD symptoms (ADHD-RS-IV total score) improved from baseline to week 52/early termination.

    “Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.”
    • Also stated in: § Introduction · plain
      “In terms of effectiveness, mean change from baseline on ADHD-RS-IV total score with LDX at the end of the study was significant, as was the mean change from baseline on the transformed YQOL-R perceptual total score.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Findling et al. 2013 source
    • Rests on an assumption: The improvements in QOL and ADHD symptoms observed during open-label LDX treatment are attributable to LDX rather than to non-specific effects, open-label bias, or the natural course of ADHD.
  • Classified as probably not a substantial claim. 22
  • May combine two claims. 19
  • The quote only partly states this claim. 1

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § Discussion

    Discrepancies between participant self-report and parent-report data have been reported, with parent-reported data considered to be more diagnostically sensitive than self-reports.

    “With regard to reporting of symptoms, discrepancies between participant self-report and parent-report data have been reported, with parent-reported data being considered to be more diagnostically sensitive than self-reports (Sibley et al. 2012).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites Sibley et al. 2012 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § Introduction

    In the 12-week pooled analyses, the largest changes reported by adolescents were improved school performance and decreased burden of disease.

    “In the 12 week pooled analyses, the largest changes reported by adolescents were improved school performance and decreased burden of disease (Berek et al. 2011).”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites Berek et al. 2011 source

      The Results section (Inventory for assessing health-related quality of life; page unavailable) reports improved school performance and a decreased ADHD-related burden at week 12; it identifies burden as the individual item with the largest mean improvement. It says school performance improved substantially, but does not establish that school performance was one of the largest changes specifically reported by adolescents. (LLM, conf=0.84)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).

    Premisecitation
    § Discussion

    There is increasing recognition of the importance of evaluating the impact of therapy on QOL.

    “There is increasing recognition of the importance of evaluating the impact of therapy on QOL (Spencer et al. 2008; Wehmeier et al. 2010)”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites Spencer et al. 2008 source
    • cites Wehmeier et al. 2010 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § Introduction

    Pooled analyses from two published 12-week open-label trials of psychostimulant medications in children and adolescents and a 4-week trial in adults reported improved QOL after treatment.

    “Similarly, pooled analyses from two published 12 week open-label trials examining psychostimulant medications in children and adolescents (Berek et al. 2011) and a 4 week trial in adults (Brams et al. 2011) reported improved QOL after treatment.”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites Berek et al. 2011 source
    • cites Brams et al. 2011 source

  • May combine two claims.

    Findingown data
    § Abstract

    Among participants with baseline self-perceived poor QOL, YQOL-R perceptual score improvements with LDX emerged by week 28 and were maintained to week 52/ET.

    “Participants with baseline self-perceived poor QOL (n=32) versus all others (n=232) exhibited robust YQOL-R perceptual score changes (improvement) with LDX, emerging by week 28 and maintained to week 52/ET.”
    • Also stated in: § Discussion · plain
      “During open-label LDX treatment, substantial YQOL-R improvements were observed at week 28 (mean [SD] score, 75.2 [10.63]; mean [SD] change from baseline, 17.6 [9.51] points) and week 52/ET (mean [SD] score, 70.0 [15.29]; mean [SD] change from baseline, 12.5 [13.02] points).”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The improvements in QOL and ADHD symptoms observed during open-label LDX treatment are attributable to LDX rather than to non-specific effects, open-label bias, or the natural course of ADHD.
    • Rests on an assumption: The improvements in QOL among participants selected for low baseline YQOL-R scores are not due to regression to the mean.

  • May combine two claims.

    Findingown data
    § Discussion

    In this post-hoc analysis, mean changes in those without self-perceived poor QOL and in study noncompleters did not meet the 0.5 SD minimally important difference threshold.

    “and mean changes in those without self-perceived poor QOL and in study noncompleters did not meet this threshold.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Findingown data
    § Results

    According to post-hoc stratification, 32 participants had self-perceived poor QOL at baseline and 232 were others; 156 were study completers and 109 were noncompleters.

    “According to post-hoc stratification of participants by perceived QOL at baseline, 32 had a YQOL-R total perceptual score ≤1 SD of the mean (self-perceived poor QOL), and 232 had a YQOL-R total perceptual score above that level; stratification of participants by trial completion status yielded 156 study completers and 109 study noncompleters.”
    Quote in the paperNot a substantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data
    § Discussion

    Among the subgroup of participants with self-perceived poor QOL at baseline (n=32), large improvements in YQOL-R total and domain scores were seen (range 9.8-17.6 at week 52/ET), maintained throughout the trial.

    “In sharp contrast, among the subgroup of participants with self-perceived poor QOL at baseline (n=32), large improvements in YQOL-R total and domain scores were seen (range, 9.8–17.6 at week 52/ET)”
    • Also stated in: § Conclusions · plain
      “A small subgroup of participants, however, perceived poor QOL at baseline and reported large QOL improvements with LDX treatment, which were maintained throughout the trial.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data
    § Abstract

    At week 52/ET, mean YQOL-R change scores ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and from +0.4 to +5.1 for all others.

    “Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others; week 52/ET improvements in ADHD-RS-IV total scores were similar, regardless of baseline YQOL-R total score.”
    • Also stated in: § Results · plain
      “Numerically greater mean YQOL-R improvements at week 52/ET were also seen in YQOL-R domain scores for those with self-perceived poor QOL (9.8–17.6) versus the others (0.4–5.1).”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The improvements in QOL and ADHD symptoms observed during open-label LDX treatment are attributable to LDX rather than to non-specific effects, open-label bias, or the natural course of ADHD.
    • Rests on an assumption: The improvements in QOL among participants selected for low baseline YQOL-R scores are not due to regression to the mean.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingown data
    § Abstract

    These post-hoc analyses included 265 participants.

    “These post-hoc analyses included 265 participants.”
    • Also stated in: § Results · plain
      “A total of 265 participants were included in these post-hoc analyses.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingcitation
    § Discussion

    In the overall study population, statistically significant improvements in transformed YQOL-R total and domain scores were seen at week 52/ET, with the largest improvements in the self and environment domains.

    “For the overall study population, significant improvements in transformed YQOL-R total and domain scores were seen at week 52/ET, with the largest improvements reported for the self and environment domains (Findling et al. 2013).”
    • Also stated in: § Conclusions · plain
      “Adolescents with ADHD who received up to 52 weeks of treatment with clinically optimized doses of LDX exhibited statistically significant improvements in QOL.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Findling et al. 2013 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § Discussion

    Parent report was not used to assess QOL in this study.

    “Moreover, a potential limitation of these data is the fact that parent report was not used to assess QOL.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § Discussion

    There are well-established functional impairments and poor life outcomes in adolescents with ADHD.

    “Despite the relatively high level of perceived QOL among most current study participants, there are well-established functional impairments and poor life outcomes seen in adolescents with ADHD (Schubiner and Katragadda 2008).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Schubiner and Katragadda 2008 source

  • Classified as probably not a substantial claim.

    Study design and conductreasoning
    § Discussion

    Because QOL was a secondary end-point, planned evaluation and statistical analyses were limited.

    “Because QOL was a secondary end-point, planned evaluation and statistical analyses were limited”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given
    § Methods

    Signed informed consent was provided by a parent or guardian, and participants signed documentation of assent.

    “Signed informed consent was provided by a parent or guardian, and participants signed documentation of assent to indicate that they were aware of the study procedures and restrictions.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § Introduction

    QOL is negatively correlated with ADHD symptom severity.

    “Decreased QOL among individuals with ADHD is well established (Klassen et al. 2004; Topolski et al. 2004; Zambrano-Sanchez et al. 2012), with QOL negatively correlated with symptom severity (Klassen et al. 2004; Matza et al. 2004).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Klassen et al. 2004 source
    • cites Matza et al. 2004 source

  • May combine two claims.

    Interpretationown data
    § Discussion

    The limited baseline QOL impairment represented a potential ceiling effect and therefore a limited ability to observe QOL improvements, particularly over the short duration of the antecedent study.

    “This represented a potential ceiling effect and, therefore, a limited ability to observe QOL improvements, particularly over the short duration of the antecedent study.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § Discussion

    The potential impact of regression to the mean contributing to the observed differences between subgroups cannot be discounted.

    “Also, the potential impact of regression to the mean contributing to the observed differences between subgroups cannot be discounted.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisereasoning
    § Discussion

    Discrepancies in the effects of treatment on ADHD symptomatology and QOL are not uncommon, most likely because of the multiple factors that can influence QOL.

    “However, it should be noted that discrepancies in the effects of treatment on ADHD symptomatology and QOL are not uncommon, most likely because of the multiple factors than can influence QOL.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S2 (checkable).

    Study design and conductreasoning
    § Discussion

    The post-hoc nature of this analysis indicates that these data should be interpreted with caution until they are confirmed in trials designed to prospectively assess these end-points.

    “and the post-hoc nature of this analysis indicates that these data should be interpreted with caution until they are confirmed in trials designed to prospectively assess these end-points.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation
    § Discussion

    The YQOL-R is designed to assess general QOL in adolescents and was validated in both normal probands in the community and in adolescents with a range of chronic disabilities, including ADHD.

    “The YQOL-R is designed to assess general QOL in adolescents and was validated in both normal probands in the community as well as in adolescents with a range of chronic disabilities, including ADHD.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Patrick et al. 2002 source

  • Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.

    Premisecitation
    § Discussion

    Adolescent/young adult perspectives on QOL and the impact of treatment may play a role in decisions to continue treatment as well as the perceived value of such treatment.

    “Moreover, adolescent/young adult perspectives on QOL and the impact of treatment may play a role in decisions to continue treatment as well as the perceived value of such treatment (Spencer et al. 2008).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Spencer et al. 2008 source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given
    § Methods

    The study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guideline E6.

    “This study was conducted in accordance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guideline E6.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation
    § Methods

    The instrument authors describe the 41 perceptual items as the "heart of the YQOL-R".

    “Although the contextual items may be useful in assessing the impact of ADHD and changes in QOL with intervention, the authors of the instrument describe the 41 perceptual items as the “heart of the YQOL-R” (Topolski et al. 2004).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Topolski et al. 2004 source

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation
    § Discussion

    In a 7-week open-label extension study of long-acting methylphenidate, improvements in hyperactivity and impulsivity were associated with improved QOL, but improvements in inattention were not.

    “For example, in a 7 week open-label extension study of long-acting methylphenidate, improvements in hyperactivity and impulsivity were associated with improved QOL, but improvements in inattention were not (Buitelaar et al. 2012).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Buitelaar et al. 2012

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Classified as probably not a substantial claim. May combine two claims.

    Interpretationnone given
    § Discussion

    QOL impairments in adolescents with ADHD are not fully understood, and limited baseline and treatment-related QOL data are available for this clinical population.

    “The current findings highlight the fact that QOL impairments in adolescents with ADHD are not fully understood; limited baseline and treatment-related QOL data are available for this clinical population.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductcitation
    § Discussion

    The QOL assessment instrument used in this study, the YQOL-R, is not ADHD-specific, although it has been validated in adolescents with ADHD.

    “Moreover, the QOL assessment instrument used currently, the YQOL-R, is not ADHD-specific, although it has been validated in adolescents with ADHD (Patrick et al. 2002).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Patrick et al. 2002 source

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductreasoning
    § Methods

    Only descriptive statistics were calculated post hoc for the YQOL-R total score and its domains and for the ADHD-RS-IV.

    “The study was not powered to detect statistically significant differences among subgroups; therefore, only descriptive statistics (e.g., mean, median, SD, standard error, 95% confidence interval [CI]) for the YQOL-R total score and its domains and for the ADHD-RS-IV were calculated post hoc.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data
    § Introduction

    Because mean baseline YQOL-R scores for the participant sample as a whole did not indicate overall self-perceived poor QOL, a potential ceiling effect may have made it difficult to detect more robust treatment-related improvements in QOL.

    “However, because mean baseline YQOL-R scores for the participant sample as a whole did not indicate overall self-perceived poor QOL, a potential ceiling effect may have made it difficult to detect more robust treatment-related improvements in QOL.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Premisenone given
    § Discussion

    Relief of core clinical symptoms may not necessarily lead to normalized functioning.

    “relief of core clinical symptoms may not necessarily lead to “normalized” functioning.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given
    § Methods

    The institutional review board of each institution reviewed and approved the consent form and the protocol.

    “In addition, the institutional review board of each institution reviewed and approved the consent form and the protocol.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductreasoning
    § Discussion

    This investigation enrolled participants who had tolerated and/or responded to either placebo or LDX in the antecedent study, so those with intolerable side effects or poor symptom response were unlikely to enroll, creating a nonrandom sample.

    “Unlike the antecedent short-term trial, the current investigation enrolled participants who had tolerated and/or responded to either placebo or LDX in the antecedent study. Those who had experienced intolerable side effects with placebo or LDX, or whose symptoms had responded poorly to study treatment were unlikely to have enrolled, creating a nonrandom sample.”
    Quote in the paperSubstantial claim
32 of 32

  • The paper relies on this without support.

    The improvements in QOL and ADHD symptoms observed during open-label LDX treatment are attributable to LDX rather than to non-specific effects, open-label bias, or the natural course of ADHD.

    “Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.”
    “This 52 week, open-label, multicenter, single-arm extension investigation was designed to assess effectiveness and safety of clinically optimized doses of LDX (30, 50, or 70 mg/day) in adolescents with ADHD who had just completed a 4 week, randomized controlled trial.”

  • The paper relies on this without support.

    The improvements in QOL among participants selected for low baseline YQOL-R scores are not due to regression to the mean.

    “Participants with self-perceived poor QOL at baseline (n=32) had a mean (SD) transformed YQOL-R total perceptual score of 57.6 (9.84) at baseline versus 82.8 (7.38) for the others (n=232).”
    “Based on a minimally important difference threshold of 0.5 SD, the improvements in QOL in those with self-perceived poor QOL at baseline would be considered to be clinically relevant.”

  • The paper relies on this without support.

    The antecedent short-term trial and the current long-term trial are sufficiently comparable that the difference in their QOL outcomes can be attributed to treatment duration and dosing.

    “It seems likely that the longer duration of treatment and the use of clinically optimized LDX dosing accounted for the differences in QOL outcomes between the studies.”
3 of 3

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Week 52/ET results are attributed to the four-week antecedent trial

    Minor

    The discussion describes week 52/ET results as findings from the four-week antecedent trial. The methods place week 52/ET in the subsequent open-label study; the antecedent trial assessed YQOL-R at baseline and week 4.

  • Quality-of-life scores are described as decreasing despite reported improvement

    Minor

    The discussion says the overall population had reductions in the YQOL-R perceptual total score, but elsewhere says that score improved significantly at week 52/ET. Higher YQOL-R scores indicate better quality of life.

  • Week 28 change for the other-participants group differs from Table 1

    Minor

    The discussion reports a week 28 change of 3.8 points for the other-participants group, whereas Table 1 reports 3.0 points. The table assigns 3.8 points to week 52, not week 28.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 3

  1. Centers for Disease Control and Prevention, 2010, MMWR Morb Mortal Wkly Rep, 59, 1439
  2. DuPaulGJ, PowerTJ, AnastopoulosAD, ReidR: ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York: Guilford Press; 1998.
  3. Schubiner H, 2008, Adolesc Med State Art Rev, 19, 209

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Authors
Childress, A. C., Cutler, A. J., Saylor, K., Gasior, M., Hamdani, M., Ferreira-Cornwell, M. C., & Findling, R. L.
Affiliations
  • Center for Psychiatry and Behavioral Medicine (US)
  • Meridien Research (US)
  • NeuroScience, Inc, Herndon, Virginia.
  • Clinical Medicine, Shire Development LLC, Wayne, Pennsylvania.
  • Biostats, Shire Development LLC, Wayne, Pennsylvania.
  • Kennedy Krieger Institute (US)
Corresponding author
Childress, Ann C.
ORCID
Venue
Journal of Child and Adolescent Psychopharmacology
Publisher
SAGE Publications
Published
2014-05
Volume
24
Issue
4
Pages
210-217
ISSN
  • 1044-5463 (ISSN-L)
  • 1557-8992
DOI
10.1089/cap.2013.0077
PMC
PMC4026374
OpenAlex
W1963776310
Semantic Scholar
02b08d46033b1a322e200a6fe2e682893e580721
Cited by
5
References
29
Citations by year
2024: 1 · 2020: 1 · 2019: 1 · 2015: 1 · 2012: 1
FWCI
0.26
Type
journal article
Language
en
Open access
Licence
www.liebertpub.com/nv/resources-tools/text-and-data-mining-policy/121/ (tdm)
Locations
  • Journal of Child and Adolescent Psychopharmacology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
Keywords
lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, adolescents, quality of life, long-term treatment, ADHD symptom improvement, study completion, baseline quality of life
MeSH terms
Lisdexamfetamine Dimesylate, Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Dose-Response Relationship, Drug, Follow-Up Studies, Humans, Psychiatric Status Rating Scales, Quality of Life, Treatment Outcome

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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-27.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-27.

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