Hareendran et al.

Health and Quality of Life Outcomes (2015) 13:133

DOI 10.1186/s12955-015-0302-9

RESEARCH ARTICLE Open Access

Evaluating functional outcomes in

adolescents with attention-deficit/
hyperactivity disorder: development and
initial testing of a self-report instrument
Asha Hareendran1*, Juliana Setyawan2, Robin Pokrzywinski3, Anna Steenrod3, Manisha Madhoo4
and M. Haim Erder5

Abstract
Background: Engaging adolescents in decisions about their health may enhance their compliance with treatment
and result in better health outcomes. Treatment outcomes in attention-deficit/hyperactivity disorder (ADHD) are
rarely evaluated from the adolescents’ point of view. There is also concern that adolescents with ADHD may not have
insight about the impacts of their disease. This article describes research conducted to understand the experiences of
adolescents with ADHD and how the research was used to develop an adolescent self-report instrument.
Methods: This research involved an iterative process to ensure content validity and was conducted in the following
stages: concept identification from literature reviews and interviews with teachers and clinicians; concept elicitation
interviews with adolescents with ADHD and their caregivers, review of existing instruments; development of a new
instrument and cognitive interviews. Experts in instrument development and translation and clinical practitioners in
ADHD also participated.
Results: A conceptual framework to measure the impact of ADHD on adolescent functioning identified from concept
identification research informed concept elicitation interviews with 60 adolescents with ADHD and their primary
caregivers. In the interviews, adolescents discussed difficulties with performing activities in various contexts:
school, home, leisure activities and social interactions. Caregivers provided additional insights. The instrument
review revealed that none of the existing instruments were suitable to collect data on the elicited concepts;
therefore, a new instrument was developed. Revisions were made to the format and content of the instrument
(a daily diary) based on feedback received from cognitive testing with 15 adolescents.
Conclusions: Our research helped to obtain a comprehensive understanding of the impacts of ADHD on adolescent
functioning, to inform the development of a new instrument for measuring outcomes. Adolescents were able to
discuss the impact of ADHD on their lives in concept elicitation interviews and report the impacts of ADHD on a
self-report instrument. The new instrument developed to reflect the perspective of adolescents with ADHD can
be used to supplement outcome assessments in clinic and research settings. Scientific advocacy for the use of such
measures can be valuable to measure outcomes meaningful to adolescents with ADHD and the clinical community.
Keywords: ADHD, Adolescent, Cognitive interview, Concept elicitation, Content validity, Development, Functional
outcome, Instrument, PRO

* Correspondence: asha.hareendran@evidera.com
1
Outcomes Research, Evidera, London, UK
Full list of author information is available at the end of the article

© 2015 Hareendran et al. Open Access This article is distributed under the terms of the Creative Commons Attribution
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Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in
this article, unless otherwise stated.
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 2 of 14

Background adolescent years, with adolescents sharing less about their

Treatments for attention-deficit/hyperactivity disorder experiences [14]. Therefore, caregiver assessments may pro-
(ADHD) aim to address symptomatic, syndromatic and vide a different perspective to what is actually experienced
functional outcomes of the disease [1, 2]. Medications by the adolescents, reaffirming the importance of collecting
for ADHD are effective in controlling symptoms such as self-reported data. Collecting data about functional out-
inattention, overactivity and impulsivity [3, 4]. However, comes that are meaningful and easily understood by adoles-
approximately 50–75 % of children with ADHD con- cents may contribute to better understanding of the full
tinue to suffer impacts associated with the disease into impact of ADHD, and for evaluating the benefits of treat-
adolescence, despite receiving treatment [5]. Increased ments for ADHD. In addition, guidelines for evaluating
cognitive demands on adolescents to appropriately func- medicinal products for the treatment of ADHD also high-
tion in academic and social settings often result in light the importance of including adolescents’ perspectives
greater morbidity owing to ADHD [6]. Treatment goals to supplement clinicians’ assessments of symptoms [15].
set for ADHD in childhood may change or expand as The objective of this study was to identify impacts of
patients navigate the transitions to adolescence and early ADHD that are most relevant to adolescents to help de-
adulthood. For example, adolescents typically have lon- velop a strategy for evaluating treatment outcomes in
ger school days and participate in more extracurricular this patient group. The study also aimed to explore the
and after-school social activities than younger children, feasibility and options available for collecting adolescent
so they may require treatment effects that last for a lon- self-reports that capture these impacts to monitor and
ger time during the day. Therefore, clinical practice evaluate outcomes of treatment.
guidelines [7, 8] for the treatment of ADHD encourage The conduct of the study was guided by the methods
the collection of data from adolescents on concepts that described in the US Food and Drug Administration
reflect their experiences, to determine targets for treat- (FDA) Guidance for Industry Patient-Reported Outcome
ment, and for monitoring and evaluating outcomes of (PRO) Measures: Use in Medical Product Development
interventions for the disease. to Support Labeling Claims [16] and the ISPOR Task
In addition to their changing environments, as children Force Reports on best practice for establishing and
grow older they are given more responsibilities by their reporting on content validity of a new PRO instrument
caregivers, and often make decisions about medication use. [17]. The study involved an iterative process to ensure
Expectations about outcomes of treatment may be different content validity, and was conducted in the following
for adolescents with ADHD compared with those of youn- stages – concept identification from literature reviews
ger children or adults with the condition. Adolescents’ be- and interviews with teachers and clinicians, concept
liefs about ADHD and attitudes to medication have also elicitation interviews with adolescents with ADHD and
been shown to drive their adherence to treatment [1, 9, 10], their caregivers, development of conceptual frameworks,
which may improve if adolescents experience treatment review of existing instruments, development of a new
benefits in the functional aspects most important to them. instrument, and cognitive interviews with adolescents to
Additionally, the desire for more autonomy and control test and refine the instrument. The methods and results
over their condition contributes to adolescents’ desire to from each of these stages of research are presented in
make decisions about medication treatment [10]. chronological order. Authors were additionally mindful
However, the evaluation of treatments for ADHD in of the criteria for reporting qualitative studies checklist
clinical trials have mainly used clinician or caregiver- suggested by Tong et al. [18].
reported assessments about the symptoms of ADHD,
such as the ADHD-Rating Scale [11], and Connors’ Concept identification research
Parent Rating Scale/Connors’ Teacher Rating Scale [12] Methods
to support clinical evaluations of benefit, as described First, a focused review of literature was conducted to iden-
in the approved product labels for ADHD medications. tify concepts for measuring functional outcomes that are
Larger discrepancies have been found in ratings of psy- relevant to adolescents with ADHD. Articles published
chopathology between caregiver and teens than between between January 2001 and July 2011 that included terms
caregivers and younger children. These larger discrepancies for ADHD, functional outcomes and patient-reported end-
have been attributed to the lack of caregiver awareness of points were reviewed. Concepts were identified through the
problematic behaviours and inconsistency in symptom review, and were also elicited from clinical and regulatory
manifestation across contexts (e.g., home, school) [13]. Par- guidelines on ADHD, selected conference abstracts, labels
ents often have less contact with adolescents compared of medicines approved for the treatment of ADHD and
with younger children, and may be less aware of adoles- results from market research with ADHD adolescents. The
cents’ day-to-day functioning. Interactions between adoles- review was conducted in 2011 and methods and results
cents and caregivers are also likely to change during have been described elsewhere [19, 20].
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 3 of 14

An interview guide was developed from the review of perspectives and elicit concepts regarding the impact of
the literature. Clinicians and teachers were interviewed ADHD on their functioning.
via telephone to identify any additional concepts related The literature review and clinician interviews also
to functional outcomes that are relevant to adolescents highlighted the need for a study design for concept
with ADHD. Clinicians were asked about goals of ther- elicitation that would be sensitive to the potential for
apy, treatment outcomes in terms of patient views, positive illusory bias (PIB) (which is an overestimation
patient characteristics that may influence outcomes and of one’s own competence compared with a criterion of
response to pharmacological therapies, and whether competence [21]) in this population. Hence, although
other clinical aspects should be considered when evalu- concept elicitation interviews with only the adolescents
ating benefits of ADHD medication. Teachers were in the absence of caregivers are recommended to inform
asked how symptoms of ADHD manifest in a school set- the development of Pediatric PRO Instruments for Re-
ting, the observed impact on functional impairments search to Support Medical Product Labeling [22], our
during school, ways in which adolescents cope with research suggested the need to also conduct interviews
ADHD, perception of medication efficacy and experience with caregivers to ensure that concept elicitation cap-
with existing questionnaires. tured all the impacts of ADHD on functioning. A special
interviewing strategy was developed to address these
Results challenges. The interview strategy is described in the
Interviews were conducted with two teachers from public section describing the methods of concept elicitation
schools and one from a private school, four psychiatrists, interviews.
one family medicine doctor, one behavioural neurologist The results of the concept identification research were
and three psychologists. Interviews with teachers identified also used to develop a preliminary framework to assess
the impacts of ADHD in the classroom and on school the impact of ADHD on adolescents functioning. The
work. For example, difficulty settling in, disrupting the resulting framework was used to probe on aspects of the
classroom, not following instructions, impact on academic adolescent experience with ADHD that had the greatest
performance, and being disrespectful or argumentative. impact on their functioning, in the context of evaluating
Interviews with clinicians highlighted broader concepts that outcomes of pharmacological interventions for ADHD.
were important to understanding the impact of ADHD on This framework included concepts on the impact of
adolescents: needing longer duration of symptom control ADHD on every day activities, social interactions and
to be able to do activities in the evening like homework or emotional function.
differences in manifestation of symptoms in adolescents
(i.e., more inner-restlessness – fidgeting rather than hyper- Concept elicitation research
activity per se). Methods
The interviews also helped to identify points to con- Concept elicitation interviews were conducted with ado-
sider for collecting information about functional out- lescents diagnosed with ADHD and their primary care-
comes from adolescents. For instance, some adolescents givers. The study received institutional review board
may lack insight into the impact of ADHD; adolescents’ approval (Schulman Associates IRB, Inc. Cincinnati, Ohio;
and primary caregivers’ perspectives of impact may dif- 27 Feb 2012 a) and all participants provided written con-
fer; clinicians also cautioned that adolescent percep- sent prior to participating in the studies (adolescents pro-
tions/recall are often coloured by their mood at the time vided assent; their caregivers provided consent).
of reporting [19]. Clinicians also helped to focus the Subjects were recruited from seven clinical sites from
investigation on concepts that were clinically relevant different regions in the USA. A purposive sampling
and likely to change as a result of medical treatments. method, usually used for concept elicitation and cogni-
For example, clinicians suggested that the impact of tive interview studies [23, 24] was used to recruit the
ADHD on social interactions may be more relevant to sample. To be eligible for participation, adolescents
evaluate than the more general concept of ‘social function’; (aged 13–17 years at the time of consent) were required
the latter may not improve with medical treatment alone, to have a clinician-confirmed (indicated by chart review)
as other variables like improvement in social skills, changes diagnosis of ADHD and no other Axis I or II, neuro-
to peer attitudes and adolescents’ self-confidence may logical or psychiatric conditions as per The Diagnostic
also need to change to result in improvement in social and Statistical Manual of Mental Disorders, Fourth Edi-
functioning. tion, Text Revision; been either off medication for at
Our research indicated that there was a paucity of lit- least 1 week (if on stimulants) or at least 4 weeks (if on
erature on adolescents’ self-report of experience with the non-stimulants), or on a stable dose of medication for at
impacts of ADHD on day-to-day functioning. A qualita- least the previous 4 weeks. Additionally, adolescents
tive study was necessary to obtain adolescents’ unique must have been able to function at an age-appropriate
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 4 of 14

level intellectually, as deemed by the study investigator, phrases provided by the subjects were selected using the
barring adolescents with any neuropsychological issues. coding dictionary and grouped into key themes, attributes,
All primary caregivers (at least 18 years of age) must concepts and relationships. Analysis of the content of coded
have lived with the recruited ADHD adolescent and outputs was conducted by two of the authors (RP and AH);
been the primary caregiver for the adolescent for at least any disagreements were discussed with a third author (JS).
the previous 6 months. Both adolescents and caregivers Content analysis was an iterative process, involving review
were not eligible to participate if they were currently and discussion between the researchers. All agreements
enrolled in a clinical trial for an ADHD treatment or were based on consensus.
had financial affiliations with the clinical recruiting site. Concepts were reviewed on a concept tracking grid
All interviews were conducted in English and audio- to ensure saturation (i.e., that emerging concepts ad-
recorded so that transcripts could be prepared, reviewed equately reflected all aspects of a measurement concept
and analysed. The conceptual framework from the con- from the perspective of the patient population of interest).
cept identification research was used to inform the The ATLAS.ti program version 7.0 was used to organize
structure and content of the concept elicitation inter- the qualitative data for analysis. The outputs of the ana-
view guide. Concept elicitation interviews started with lyses were used to inform item generation.
an open-ended discussion about the impact of ADHD
on functioning, followed by questions about everyday
Results
activities (using the reconstruction of a typical school
Sample
day, to ensure that the impacts of ADHD at different
Of the 60 adolescents who participated in the concept
times of the day were explored), social interactions and
elicitation interviews, 67.0 % were male, 85.0 % were
emotional functioning. At the end of the interview, other
white, and 78.0 % lived in families with both primary
concepts such as impact on non-school days, weekends
caregivers. All adolescent participants were full-time stu-
or holiday activities were discussed. All interviews were
dents in the 7th–12th grade. Most adolescents were cur-
conducted in person and each interview took approxi-
rently taking medication (83.3 %), and described the
mately 90 min to complete.
severity of their ADHD as mild (60.0 %). Interestingly,
The data collection approach for the study was designed
only 13.0 % reported that they were responsible for man-
to elicit concepts to avoid missing insights about the
aging their medication without a caregiver’s aid.
impact of ADHD on the adolescent as a result of PIB.
The primary caregivers interviewed included mothers
Data were collected from two cohorts. Cohort 1 involved
(88.3 %), fathers (8.3 %) and a grandparent (3.3 %);
separate one-to-one interviews that enabled concept elicit-
50.0 % worked full-time and 13.3 % self-reported that
ation from the adolescent without the caregiver and from
they had also been diagnosed with ADHD.
the caregiver without the adolescent.
Sample demographics and clinical characteristics from
For Cohort 2, adolescents and caregivers were inter-
the concept elicitation and cognitive interview studies
viewed together. During Cohort 2 interviews, questions
are shown in Table 1.
were addressed to the adolescent first and then to the
caregiver for further contributions to the discussion.
Caregivers were also encouraged to remind their adoles- Descriptions of the impact of ADHD from concept
cent about specific examples if the adolescent had not elicitation interviews
mentioned them. At the end of the interview, adolescents Adolescents discussed the impact of ADHD on their
were interviewed on their own to provide an opportunity functioning in terms of (a) difficulties with everyday ac-
to discuss impacts that they may have hesitated to share in tivities in various contexts such as: school (learning and
the presence of their caregiver. extracurricular activities); home (e.g., early morning
Adolescents and caregivers also completed a set of self- tasks, household chores, home work); leisure (after
administered questionnaires, including a socio-demographic school clubs, hobbies, sports, part-time or voluntary
questionnaire at the end of the interviews to help work); and (b) difficulty interacting with: family (care-
characterize the sample. All subjects were compensated for givers and siblings); friends (peer group, friends); and
the time spent for participation in the study. people in authority (e.g., teachers, coaches and team
A content analysis approach was used to analyse data leaders). Emotional difficulties resulting from these im-
from the interviewers’ field notes, and from the transcripts pacts were also reported, such as feeling stressed about
of audio-recorded interviews. A phenomenological ap- performing tasks and social interactions. In addition to
proach [25] was used to identify concepts that were rele- these impacts, caregivers and a few older adolescents
vant to explore adolescents’ experiences with ADHD. A also reported problems with regulating emotions. Table 2
coding dictionary was developed based on the themes and provides representative quotes for specific concepts
concepts that emerged during the discussions. Words and within the three domains.
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 5 of 14

Table 1 Sociodemographic and clinical characteristics of adolescents with ADHD

Concept elicitation study Cognitive interview study
Young ADHD Older ADHD Total sample Young ADHD Older ADHD Total sample
adolescents, 13–14 adolescents, 15–17 (N = 60) adolescents, 13–14 adolescents, 15–17 (N = 25)
years (n = 25) years (n = 35) years (n = 13) years (n = 12)
Sociodemographic characteristics
Mean (SD) age, years 13.8 (0.6) 16.2 (0.8) 15.25 (1.4) 13.6 (0.5) 16.0 (0.7) 14.8 (1.4)
Male, n (%) 20 (80.0) 20 (57.1) 40 (66.7) 11 (84.6) 7 (58.3) 18 (72.0)
Racial background*,†,‡,§,¶, n (%)
White 22 (88.0) 29 (82.9) 51 (85.0) 12 (92.3) 12 (100.0) 24 (96.0)
Hispanic or Latino 5 (20.0) 9 (25.7) 14 (23.3) 2 (15.4) 0 (0.0) 2 (8.0)
Black or African American 3 (12.0) 5 (14.3) 8 (13.3) 0 (0.0) 1 (8.3) 1 (4.0)
Asian 3 (12.0) 3 (8.6) 6 (10.0) 1 (7.7) 2 (16.7) 3 (12.0)
† ‡ § ¶
Other 3 (12.0) 3 (8.6) 6 (10.0) 1 (7.7) 3 (25.0) 4 (16.0)
Living/domestic situation, n (%)
Live with both parents (caregivers) in 20 (80.0) 27 (77.1) 47 (78.3) 13 (100.0) 10 (83.3) 23 (92.0)
the same home
Live with single parent/caregiver 3 (12.0) 5 (14.3) 8 (13.3) 0 (0.0) 2 (16.7) 2 (8%)
Live with both parents/caregivers in 2 (8.0) 1 (2.9) 3 (5.0)
different homes (shared custody)
Live with guardian 2 (5.7) 2 (3.3)
Clinical characteristics
Mean (SD) duration of ADHD, years** 5.33 (2.3) 6.03 (3.8) 5.74 (3.24) NR NR NR
Diagnoses from clinical chart review
(DSM code) [28], n (%)**
ADHD, code not specified 3 (12.0) 5 (14.3) 8 (13.3) 0 (0.0) 0 (0.0) 0 (0.0)
ADHD, predominantly inattentive 6 (24.0) 14 (40.0) 20 (33.3) 6 (46.1) 10 (83.3) 16 (64.0)
type (314.00)
ADHD, predominantly hyperactive/ 16 (64.0)†† 16 (45.7)‡‡ 32 (53.3) 7 (53.8)§§ 2 (16.7)§§ 9 (36.0)
impulsive type or combined (314.01)
Adolescent self-reported ADHD
severity on day of interview, n (%)¶¶
Mild 16 (64.0) 20 (57.1) 36 (60.0) 9 (69.2) 7 (58.3) 16 (64.0)
Moderate 7 (28.0) 14 (40.0) 21 (35.0) 3 (23.1) 4 (33.3) 7 (28.0)
Severe 2 (8.0) 1 (2.9) 3 (5.0) 1 (7.7) 1 (8.3) 2 (4.0)
Treatments for ADHD, n (%)**,†††
Medications or drugs 19 (76.0) 31 (88.6) 50 (83.3) 13 (100.0) 12 (100.0) 25 (100.0)
Counselling/therapy 6 (24.0) 3 (8.6) 9 (15.0) 3 (23.1) 2 (16.7) 5 (20.0)
Coaching 1 (4.0) 2 (5.7) 3 (5.0) 1 (7.7) 0 (0.0) 1 (4.0)
Specialized assistance at school 12 (48.0) 12 (34.3) 24 (40) 5 (38.5) 2 (16.7) 7 (28.0)
Other 2 (8.0) 1 (2.9) 3 (5.0) 0 (0.0) 0 (0.0) 0 (0.0)
*Not mutually exclusive
‘Other’ includes: †Kazakhstan (n = 1); Brazilian (n = 1); ‡Native Hawaiian or Pacific Islander (n = 1) and Asian-European (n = 1); §South American (n = 1); ¶Native
Hawaiian or Pacific Islander (n = 2) and Mediterranean (n = 1)
**From Clinician chart review; DSM- Diagnostic and Statistical Manual code
††
Further subtypes: combined = 14; predominantly hyperactive/impulsive = 2
‡‡
Further subtypes: combined = 13; predominantly hyperactive/impulsive = 3
§§
Information on subtypes was not available for this sample
¶¶
No adolescents reported their ADHD as very severe on the day of the interview
†††
Not mutually exclusive
NR Not recorded, SD standard deviation
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 6 of 14

Table 2 Quotations from interview participants

Concept Adolescent quotes Caregiver quotes
Everyday Morning • I just waste a lot of time in the morning • He goofs around a lot in the morning
activities
• Mom always has to be pushing me telling me like • I have to remind her to do her hygiene
hurry up, hurry up
• She has left the house without brushing teeth
• I would probably forget to like get dressed in the
morning if it weren’t for my mother
School work in the • If I wasn’t paying attention in one class I would • The thing is that she’s distracted…
classroom have a much harder time taking the test on the
• She will just stare at the window, stare at the wall
material than other students would
• He’s not on the reading level, and the math level
• When they do stuff in class I’m usually pretty slow,
that he’s supposed to be on
slower than other people
School work - • I regret not being able to like focus…. • It’s always been difficult for her to sit down, do
homework homework, and remember to turn it in
• Because then I’ll get side-tracked and I’ll do some-
thing else and then I’ll run out of time, then I’ll have
to do it in the morning
School behaviour – in • I sort of just yell it out… • She’s gotten into trouble with teachers by not-not
the class room or keeping her mouth quiet or being respectful when
during breaks • I don’t remember ever getting up or why I got up she needs to be
• I can’t like sit in one spot and just kind of like sit
here like this all, like for 90 min and just go like this
Difficulty with leisure • I’ll start playing something other than a (musical) • With the focus, might get him a little distracted
activities piece I’m supposed to be playing during a (sports) game when he needs to be paying
attention
Difficulty with chores • Loading the dishwasher no one really likes, but it • He’ll say he’s going to do something like take the
and other task at takes me apparently the longest amount of time recyclables out back or whatever and-, you know, 2 h
home in the evenings later or 3 h later he hasn’t
Social Difficulty interacting • Usually I just go in my room and lock myself in, • This morning we had a big fight because as usual
interactions with family and just play video games and not talk to anyone she’s thinking two minutes before she has to walk
out the door about something she has had to do for
• Yelling at my sisters sometimes, being mean to
the last couple months
my sisters-because like when I’m really stressing I’m
a little edgy and I kind of snap really easily • He doesn't know how to stop. It's like, if I yell, just
stop, everybody will stop, but him
Difficulty interacting • I’ll talk really fast and I won’t focus on anything- • She also alienated herself from the rest of the class
with friends they’re talking to me, I kind of just like zone out a because she fell behind
lot
Difficulty interacting • I’ll joke around in a teacher’s class… • She’s been in trouble at school, uh, because, uh-you
with teachers may want to talk to her about how she-with teachers
• I would start yelling at her and I got in a lot of and controlling her speech
trouble for that
Emotional General stress • When I have a lot of stuff after school I’ll usually • She’s admitted that she’s feeling more stressed, just
response to be more just tensed up and just more irritated- as other things loom in her life
difficulty with irritable
ADHD
• I usually get like a headache or whatever because
of the stress
Stress related to • Usually I’m kind of like nervous, kind of • I think he’s so paralyzed by anxiety for-in social
interactions with embarrassed, too, if I’m like in a large group of situations….
peers, family, or people at a presentation or something
authority
• I get really nervous, I think, and I worry a lot and
that’s how I get distracted
Stress related to • Uh, it’s just like trying to not fail. Like I really, I
• She just-so she was under a lot of pressure intern-
school work and really hate failing, and I just hate the feeling ally obviously to get this done and just completely
homework fell apart and, you know, was in tears and everything
• I was more worried about, oh, you know, I have to
like that.
do this, I have to do this homework, I have to turn
this packet in and everything, everything, • At night if there’s too much of it she’ll have
everything complete anxiety attacks and mental breakdowns
occasionally if the pressure is just too much
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 7 of 14

When describing their difficulties, most adolescents grew older, and were able to provide fewer insights into
discussed the level of effort that they needed to accom- the social difficulties experienced by their adolescents.
plish tasks, manage their behaviour or to engage in con- Adolescents also reported on difficulties with interact-
versations. Adolescents provided examples to illustrate ing with family members, and avoiding interactions
how difficult it was to do things because of their ADHD because they were difficult. When discussing interactions
in various contexts, and shared how these difficulties with authority figures, fewer adolescents reported diffi-
stressed them out. For example, a 17-year-old girl with culty, although the main problem reported was regarding
ADHD said: “…this whole junior year has been very interactions with teachers at school. A few adolescents
stressful, stressful…. I think it was hard, I think it’s who participated in sports also mentioned similar prob-
harder for me because, ‘cause of my ADHD like, yeah, lems with coaches. Caregivers also consistently reported
okay, my ADHD is hard to, just like very hard to focus.” difficulties with communication and arguments about
Adolescents mainly reported difficulty with tasks that poor performance or forgetting to do tasks. Regarding in-
need attention. Difficulties with focus appeared to be the teractions with peers, a few adolescents reported problems
primary difference they notice when not on medication. with getting into arguments, being impulsive and lacking
They also reported difficulty with completing tasks prop- etiquette both in and outside of school. While adolescents
erly and on time, remembering things and following reported no trouble keeping or making friends, caregivers
instructions. Difficulties with behaving well during class reported adolescents were not doing as well socially as
included examples of being reprimanded by teachers for other children.
‘blurting things out’ or not waiting their turn, and inter- Parents typically provided additional insights into the
rupting the class by moving around, fidgeting or dropping specific difficulties that their adolescents faced as a
things, thus causing a distraction to others. Difficulties at result of other symptoms of ADHD (impulsivity and
home included examples of ADHD symptoms interfering hyperactivity). For example, a caregiver of a 15-year-old
with getting ready for school on time in the mornings, the boy with ADHD reported on the difficulty their child
need for multiple reminders from their caregivers in the had because of being impulsive, but was also able to
mornings before school and difficulties with completing report on change to this difficulty over time: “…they-
homework or chores in the evenings. They also mentioned these kids come to see my younger son…. um, so if they’re
that their ADHD symptoms had an impact on leisure doing something… playing on the computer or on the
activities, including the activities that they performed in trampoline. But there are, I’m sorry, there are times
after-school clubs, sports, volunteering or part-time work. when, um [Son with ADHD], again, will get very upset
Caregivers reported similar difficulties but reported with these neighbor kids because something-something he
impairment perceived in terms of the consistency and has perceived that they’ve done, um, and that is better
quality of activities performed. Caregivers also reported though now than it used to be. A few years ago he would-
that the adolescent with ADHD lacked ‘motivation’ and he might beat them up, um, but now he just might, I don’t
procrastinated. know, walk away or say something rude to them or some-
When speaking about social interactions, difficulties thing, it’s much less, um, physical than it used to be.”
interacting with family members and with peers/friends Another caregiver reported: “I think, um…I think
were typically discussed by both adolescents and care- [<Son>] has social challenges. I don’t think he thinks he
givers. In general, older adolescents were able to report does, um, I think they are definitely related to his
on some specific difficulties with social interactions (e.g. A-ADHD, um, and that’s because he gets in your face
difficulties with listening/not focusing on what others when he’s not on medication and he’s jumping around
were saying) compared with younger adolescents. For and moving around and it’s just-it’s irritating. And I
example, a 16-year-old girl with ADHD said: “Yeah, I’m could see where his peers would get tired of that fast,
much more-much hyper, really hyper, I’ll talk really fast where he can’t just have a conversation.” Further exam-
and I won’t focus on anything-they’re talking to me, I ples are provided in Table 2.
kind of just like zone out a lot… Yeah, they say something Most adolescents described feelings of stress related to
and then I’m just like ‘what, repeat that, I didn’t hear their performance of tasks or social interactions because
you’-and they get all mad because they feel I wasn’t pay- of their ADHD, using terms such as guilt, worry, anxiety,
ing attention.” stress/stressed out and irritable to describe their emo-
Older adolescents also reported on the greater tions. In the school setting, adolescents provided exam-
demands placed on their social skills because of their ples of stress with completing classroom work properly
ADHD. The need to listen and focus on conversations, and on time, remembering things, following instructions,
participate in more reciprocal communication, engage in behaving well during class, interacting with teachers and
dating and group activities increased as they grew older. peers. Adolescents reported feeling stressed in school
Parents reported seeing less of their adolescent as they owing to not understanding the work, not keeping up
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 8 of 14

with the rest of their class during lessons, and getting that some of the concepts reported by adolescents and
behind in school work largely owing to their difficulty their caregiver as an impact of ADHD, such as emo-
with keeping focused on lessons. Adolescents provided tional lability, were likely to be part of the psychopath-
examples of stress, such as getting ready for the day on ology of the disease rather than an impact of the core
time in the mornings, completing homework or chores symptoms of ADHD. Clinicians also helped to focus the
in the evenings, and interacting with family members. concepts in the framework on the impact of the symp-
Parents used the term anxiety to describe the adoles- toms of ADHD on function, rather than the functional
cents’ experiences and reported on difficulties that ado- impairments noticed by most caregivers of adolescents
lescents had with the control of their emotions, mostly without ADHD. The results also showed that social
anger, in terms of temper outbursts. A few caregivers functioning in adolescents was closely linked to the so-
also mentioned excessive sadness in the adolescent. cial settings to which they are exposed, rather than just
ADHD significantly impacts aspects of adolescent func- being an individual with ADHD. Clinician interviews
tioning. Adolescents and caregivers provided different per- had highlighted previously that social functioning may
spectives of the adolescents’ experiences of ADHD. For not respond to pharmacological treatments alone.
example, in an interview in Cohort 1 where the adolescent Therefore, the concept to evaluate adolescents’ experi-
and his caregiver were interviewed separately, the care- ences with ADHD was focused on difficulty with social
giver reported that her son with ADHD was in a tagging interactions, rather than more distal concepts about
crew (a form of gang that is involved with activities such their social functioning (e.g., making/keeping friends,
as illegally spraying graffiti across public property), and on getting into the wrong groups), as these would be influ-
occasion she has had to phone the police regarding her enced by environmental and social factors other than
son to help discipline her child’s illegal activities. In the in- ADHD. Based on the results above, the following con-
dividual interview with the son, despite being probed cepts were considered as core concepts to collect data
about getting into trouble, he did not mention this. from adolescents to understand the impact of ADHD on
While caregivers were more open about reporting on adolescent functioning, and relevant to evaluate out-
incidents where adolescents had experienced difficulties, comes of pharmacological treatment. The final concep-
with prompts adolescents did not refute these incidents. tual framework for evaluating the impact of ADHD on
This is illustrated in the quote below, during a discus- everyday activities and social interactions in adolescents
sion about the impact of ADHD on leisure activities with ADHD is illustrated in Fig. 1.
from a Cohort 2 interview, where the caregiver and ado- Adolescents reported that the level of difficulty varied
lescent were interviewed at the same time. at different times of the day. They also reported that
Parent: “….So just because he’s doing it and liking it they would find it hard to recall their difficulties more
doesn’t mean he’s happy about it in the end.” Inter- than a few days in the past.
viewer: “Why would you say that is then?” Adolescent:
“Um, well, like sometimes when I’m playing FIFA I will
keep-it will start to get boring after I play a couple of Tool review
games. So then I’ll go outside and ride my bike. And so I Methods
can’t just stay on one thing for like the whole day.” To determine whether published tools that measure
The concept tracking grid to evaluate saturation of functional outcomes in ADHD covered the concepts
concepts showed that across interviews, adolescents re- that are meaningful and important to adolescents with
ported similar difficulties in the context of home, school ADHD, a review was conducted to identify tools used in
and leisure, supporting saturation. clinical trials in adolescent ADHD. PRO instruments
were identified based on a review of select conference
Develop a conceptual framework abstracts, clinical trials.gov, the Patient-Reported Outcome
The concepts identified through concept elicitation in- and Quality of Life Instruments Database (PROQOLID),
terviews were used to revise the preliminary conceptual and the Patient Reported Outcomes Measurement Infor-
framework developed previously based on the concept mation System (PROMIS) database. The contents of the
identification work. The revised framework was shared tools were reviewed to identify a) the best coverage of con-
with clinicians and was modified further based on their cepts emerging from the concept elicitation work and b)
feedback, to ensure clinical relevance and to highlight methods used to generate the items and assess if they meet
concepts that were more useful to capture the outcomes criteria for content validity required for PRO tools used to
of pharmacological interventions for ADHD (the context support label claims [16, 17]. This produced a short list of
of use for the new instrument). This resulted in a few tools for further examination of the domains and specific
revisions to the conceptual framework for measuring the items used to evaluate functional outcomes for their rele-
concept of interest. For example, clinicians suggested vance for the adolescent ADHD population.
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 9 of 14

Fig. 1 Impact of ADHD. a Everyday activities. b social interactions

Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 10 of 14

Results elicitation interviews, clinician feedback, and considerations

Thirty-four tools were identified from the review; 11 had from the initial concept identification research were dis-
adolescent-specific versions. An item ‘pool’ was developed, cussed. Input from the instrument development team
which included the items selected from instruments that members (authors of this manuscript) were used to con-
cover the concepts from the conceptual framework. struct the items. Items were developed using an iterative
Adolescent-specific versions largely included concepts simi- process of: item development, review and revisions. Review
lar to the child versions, with some adjustments to match and discussions referred back to qualitative data from the
developmental stage, and were more likely to be self- interviews to inform the decision-making process. External
reported. reviews of the instrument were conducted by ADHD
In reviewing the content of the tools, the Weiss Func- clinicians and translatability experts.
tional Impairment Rating Scale-Self (WFIRS-S), a self- Concept elicitation research suggested that the impact
reported scale to evaluate symptoms and functioning in of ADHD on functioning was reported by adolescents in
adults with ADHD, covers seven conceptual domains terms of the level of difficulty or effort required to do
(family, work, school, life skills, self-concepts, social and their school work, leisure activities and tasks at home.
risk), and had the best coverage of concepts. However, Response options for the instrument were thus selected
the tool has some shortcomings in terms of suitability of to enable adolescents to specify how hard it was to
use for evaluating outcomes of pharmacological inter- do/how much effort was required, to function. Two
ventions from the adolescent’s perspective. Firstly, item types of scales for obtaining response options – a numeric
generation for the tool was not supported by concept rating scale (NRS) and a visual analogue scale (VAS) – were
elicitation work with an adolescent population. Add- developed for testing in cognitive interviews.
itionally, the recall period of the tool is the ‘past month’, To capture the variability of the adolescent experience
which may not capture the variability of the impact of over the course of a day, and to ensure shorter recall pe-
symptoms on functioning as experienced by varying de- riods to address recall bias, the instrument was designed
mands of the days for adolescents and would be challen- to be administered twice daily (at the end of the school
ging for adolescents to complete as they mentioned day and in the evening before bed). An electronic plat-
difficulty recalling impacts over longer periods of time. form was selected to facilitate the ease of completion,
Finally, the WFIRS-S collects information about the fre- enhance compliance (with the inclusion of features such
quency of impacts rather than the level of difficulty of as the ability to set time windows and reminder alarms
functioning experienced and reported by the adolescent to facilitate the completion of the instrument during the
with ADHD. Based on the review, development of a new specified timeframes), include examples of terms on the
instrument was deemed the most appropriate strategy. screen, and also ‘pop-up’ definitions if the participant re-
quires additional information. At the end of the school
Item generation day, adolescents were asked to indicate the magnitude of
The findings from concept elicitation interviews and re- difficulty or effort required to do the following – ‘how
sults of instrument review suggested the need for an in- hard was it to’: get ready for the day in the morning, do
strument: a) with a shorter recall period; b) that collected school work, behave well in the classroom, interact with
information about the level of difficulty and effort required family members in the morning and/or interact with
by the adolescents; and c) that evaluates the impact of friends and teachers at school. Another item asked how
ADHD on functioning in different contexts (school, home, stressed they felt about school work that day (seven
and leisure) from the adolescent’s perspective. The tool items). At the end of the day, adolescents were asked to
review found no such instrument to fill this need. indicate the magnitude of difficulty or effort required to
Best practice guidelines were used to guide the process do the following – ‘how hard was it to’: do homework,
of generating items [17]. This included the creation of chores, sports or hobbies and interact with friends and
questions, recall period and response choices. Items family. Another item asked how stressed they felt about
were generated using patient terminology to reflect the doing their homework that evening (six items).
concepts relevant to adolescents’ understanding of their The instrument also includes items that ask the ado-
experience of impacts from ADHD as defined in the lescent to indicate their overall level of stress at three
modified conceptual framework. A pool of items identified time points in the day – morning, school day and even-
from existing questionnaires during concept identification ing, and some optional items that can help to
was used as a reference to inform item construction. For characterize the adolescents’ experience such as: “Did
formulation of the questions and the construction of the in- you leave home on time this morning?” and “Did you
strument, methods outlined by Streiner and Norman [26], have all the materials that you needed to complete your
were followed. Item generation started with an all-day homework or other work for school?”. Figure 2 shows an
meeting where the results from the qualitative concept example question from the instrument. The final
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 11 of 14

Fig. 2 Sample item from instrument

conceptual framework and scoring methods will be de- examining: 1) the clarity of the items within the scale; 2)
termined following psychometric validation studies. participants’ interpretation of the items; 3) ease of question-
A translatability assessment and a lexibility (reading naire completion; 4) comprehensiveness and relevance of
level) evaluation were conducted on the draft instrument the measure; and 5) appropriateness of the format, response
prior to testing the instrument to ensure that the items scales and recall period. The analysis also focused on the in-
were translatable and that the reading level was appro- structions and content coverage of the questionnaires to
priate for adolescents aged 13–17 years. The instrument ensure items fully captured the impact of ADHD on func-
was finalized for cognitive testing. The translatability as- tioning. After the completion of Round 1 (n = 8 interviews),
sessment helped to identify words or phrases that were an interim analysis was conducted using the criteria listed,
structurally or culturally problematic when translated and modifications were made accordingly and retested dur-
into different languages for potential use in multicountry ing Round 2 interviews (n = 17 interviews) before finalizing
clinical trials. This included revisions to the diary such the instrument.
as spelling out times of the day as an alternative to a 24-
hour clock, as well as rephrasing statements and re- Results
placing words for clarity such as ‘to reach transportation Twenty-five adolescents were interviewed across the two
for school’ instead of ‘to get transportation to school’. rounds of interviews. Similar to the sample for concept
elicitation interviews, all of the adolescents included in
Cognitive interviews the cognitive interview study were currently taking
Method medication (100 %) and most described their ADHD as
Cognitive interviews were conducted to gain insight into mild (64 %). A smaller percentage of adolescents in the
subjects’ interpretations of the items, match the intent cognitive interview study (28 %) reported having special-
of the items and assess whether any critical content ized assistance at school compared with those included
(concepts or items) had been omitted from the instru- in the concept elicitation study (40 %) (Table 1).
ment. All interviews also explored the suitability and ap- All adolescents were able to complete the instrument.
propriateness of response options and recall periods, Specifically, adolescents reported that the instructions
and also preferences for an NRS or a VAS to select were clear, the content of each question was appropriate,
responses to items [17]. The patient population was and that they understood the content of the questions as
recruited using similar criteria and narrow age groupings it was intended by the instrument developer. None of
from the concept elicitation study. Two rounds of inter- the adolescents mentioned any concepts that were miss-
views were conducted to allow for adjustments. Round 1 ing. A range of responses was chosen by adolescents,
included eight adolescents and Round 2 included 17 suggesting the presence on impacts of ADHD on the
adolescent interviews. Institutional review board ap- day of the interview. Furthermore, adolescents were able
proval (Schulman Associates IRB, Inc. Cincinnati, Ohio; to explain why they chose a specific response option and
16 May 2013) was received and all participants provided provide an example of a time they may have chosen a
written consent prior to participating in the study (pro- different option. This helped to confirm that the instru-
vided assent and consent as required). All interviews ment was well understood and that adolescents had in-
were conducted in English and audio-recorded so that sights into the impact of ADHD on their functioning.
transcripts could be prepared, reviewed and analysed. Results also showed that for response options, an NRS
Feedback received from adolescents with ADHD during was preferred over the VAS. Overall, all the changes
the cognitive interviews was used to improve the question- made to the instrument were minor. These changes in-
naire. The analyses of data from these interviews included cluded switching the order of text, removing
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 12 of 14

unnecessary text and/or adding in words or phrases to potential PIB in conditions where deficits in executive
help to clarify the intent of the items. A term change for functioning may have been present, as was reported by
emotional functioning that emerged was to change Owens et al. [21]. Additionally, taking into consideration
‘stressed’ to ‘worried’ for interactions with others in the attention deficit and potential difficulty with recalling
evening. In addition, modifications were made to the experiences, and based on feedback from clinicians, a
‘pop-up’ descriptions developed to facilitate adolescents’ predefined structure using a day reconstruction ap-
understanding of items. These statements or descrip- proach, as well as use of specific probes, facilitated con-
tions usually included examples of activities associated cept elicitation. Insights gathered from both adolescents
with the item such as ‘difficulty focusing while talking, and caregivers provide a more comprehensive picture in
family members not understanding’, and were therefore describing the impact of ADHD on adolescent functioning,
modified to be more relevant to the adolescents’ experi- suggesting the value of conducting concept elicitation inter-
ences. One participant (16-year-old boy) suggested chan- views with both adolescents and their caregivers. Adoles-
ging the name from diary. “…I would I don’t know, maybe- cents with ADHD reported more about the difficulties and
I’d just say test or complete this packet. Just not diary, no, the degree of effort that they required to perform their day-
with that I think of like a 12- to 14-year-old girl writing to-day activities than parents who reported on the occur-
about who knows what.” The name of the instrument was rence and frequency of the impacts that they observed.
hence revised to ‘a schedule’ instead of ‘diary’. The results While the findings of this study supports the value in cap-
of this research confirmed the impact of ADHD on adoles- turing the perspectives from caregivers and adolescents,
cent functioning that is mentioned in the literature, and further study is required to explore the pros and cons of
highlights concepts that should be evaluated to understand interviewing adolescents and their caregiver separately.
treatment outcomes that are meaningful to adolescents. The qualitative study provided evidence supporting ado-
lescents’ ability to self-report on the impact of ADHD.
Discussion Concept elicitation interviews identified functional con-
Most children with ADHD continue to suffer impacts cepts of impairment including: difficulty performing tasks;
associated with the disease into adolescence, despite difficulty related to interactions; and feelings of stress
receiving treatment. This has been attributed to the about difficulty with school work and performing tasks.
increasing demands placed on adolescents at school and The findings are similar to Goodman et al. [6], with re-
at home [5, 6]. While this has been reported through spect to reports of greater demands in adolescents in func-
case series, little is known about the full scope of the tional areas such as academic and social settings. While
impact of ADHD on adolescents’ function. Additionally, the adolescents provided insight to their academic and so-
most instruments developed to evaluate outcomes of cial settings, the caregivers were able to report supplemen-
treatment in this population rely on parent or physician tal details about observations from their perspectives. The
reports rather than direct reports from adolescents [11], caregivers, for example, could comment on the number of
which may impact our understanding of outcomes that social activities while the adolescents could comment
are most important to adolescents. This study aimed to about how ADHD symptoms impaired their social interac-
address these gaps by first identifying and defining the tions. The dynamic between adolescent experience and
concepts that have the greatest impact of ADHD on caregiver observation that was reported in this research is
adolescents’ functioning, from the perspective of the consistent with Achenbach et al. [13]. Adolescents re-
adolescent and secondly, using the results to inform the ported the impact of ADHD on daily functioning in vari-
development of a new instrument. ous contexts – at school, at home and during leisure time.

Methods for identifying and defining the concepts from Development and testing of a new instrument
adolescents with ADHD Review of the instruments developed previously demon-
Concepts related to the impacts of ADHD and methodo- strated incomplete coverage of the important concepts
logical considerations identified from concept identifica- for assessing the impact of ADHD on functioning identified
tion phase were used to design the study and informed during the concept identification and concept elicitation
the data collection approach. As low concordance be- studies. Therefore, a novel instrument was developed for
tween reports by parents and adolescents was reported adolescent self-report, focusing on outcomes that are likely
in the literature [13], the qualitative research study was to respond to successful medical intervention in the context
designed to supplement data collected from interviews of a clinical trial. Inclusion of clinicians’ perspective helped
with adolescents, with caregiver interviews. The design to ensure the clinical relevance of the tool. For example,
also explored options for data to be collected separately collecting data on areas where adolescents may be able to
from both perspectives and together. This approach en- perceive improvement (e.g., difficulty with social inter-
abled cross-examination of both perspectives, addressing action), rather than areas where improvements are the
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 13 of 14

consequence of external factors (e.g., social functioning – well as in clinical studies, hence allowing evaluation of out-
peers need to see the difference, then their minds need to comes that are meaningful to adolescents. However, there
be changed). The development of this new tool followed are a few limitations to the research that should be consid-
the processes as outlined by a USA regulatory agency [16], ered when evaluating the application of the instrument. To
as well as specific development guidelines for content valid- start, the sample of adolescents interviewed was relatively
ity [17] and recommendations for the assessment of chil- homogenous, with white males making up a large majority
dren and adolescents [22]. of those adolescents interviewed in the study. Most of the
The generation of new items for the PRO instrument participants were recruited from only two states (Virginia
captures adolescents’ experiences during different times and California) within the USA, which may not reflect the
of the day. The daily variability in adolescents’ schedule, general population of ADHD participants. Additional re-
coupled with the variation of experiences and difficulties search on the concept elicitation approach to compare
owing to ADHD, as well as the adolescents’ inherent dif- concept elicitation with and without caregivers, and in dif-
ficulty with remembering past experiences, suggests that ferent countries, ethnicities and cultures is warranted. The
data regarding these concepts may need to be captured diagnosis and sub-types of ADHD (Table 1) were based
more frequently to support the need for adolescents to only on information available on patients’ charts; no clin-
respond to questions based on a shorter timeframe. ical assessments were conducted for the study to confirm
None of the existing PRO tools include a short recall the diagnosis or ADHD sub-type. Further quantitative
period (e.g., WFIRS-S uses the past month recall). A evaluation of the instrument should also be conducted to
short recall period was used to prevent reporter bias determine methods for scoring and to explore the psycho-
based on clinician report and research suggesting that metric properties of the instrument, as well as to assess the
ADHD impairs working memory [27]. sensitivity to change of these scores resulting from
For adolescents with ADHD the magnitude of difficulty interventions.
with performing the task and the effort to perform the task
appeared to be more relevant than the actual occurrence or
absence of the functional impairment. Understanding the
Conclusion
This study provides a comprehensive understanding of
benefit of treatment in terms of whether or not it reduces
the impacts of ADHD on adolescent functioning, which
the level of effort to perform tasks may resonate better with
has been used to inform the development of a new in-
adolescents, when evaluating outcomes of treatment in
strument for measuring outcomes. Adolescents were
clinical trials or monitoring outcomes in clinical practice.
able to discuss the impact of ADHD on their lives in
The response options that reflect changes in the level of dif-
concept elicitation interviews and report the impacts of
ficulty or effort required by the adolescents if their ADHD
ADHD on a self-report instrument. A new instrument,
symptoms were controlled assess two key measurement as-
that was developed based on these findings, can be used
pects of ADHD functioning. This includes the focus on the
to supplement assessments in clinic settings and re-
performance of daily activities rather than the perception of
search, and to evaluate outcomes that are meaningful to
their performance, removing any bias in adolescents’ ability
adolescents. Scientific advocacy for the use of such in-
to complete a task per FDA guidance. Secondly, the focus
struments can be valuable to measure outcomes that are
on capturing the level of difficulty required to complete a
meaningful to the ADHD adolescents and the clinical
task, rather than frequency of impairment, has the potential
community. To continue to build on this research founda-
to provide more meaningful measurement of behaviour
tion, additional quantitative work should be done to valid-
and functioning.
ate the concepts and instrument to facilitate improved
The content validity of the instrument was established
measurement of treatment effects among adolescents.
through cognitive interviews where adolescents com-
pleted the instrument, providing insights on the selec-
Abbreviations
tion and meaning of their responses. Results from these
ADHD: Attention-deficit/hyperactivity disorder; FDA: US Food and Drug
interviews suggest that adolescents had valuable insights Administration; NRS: Numeric rating scale; PIB: Positive illusory bias;
into the impact of ADHD, and could report on these PRO: Patient-Reported Outcome; PROMIS: Patient Reported Outcomes
Measurement Information System; PROQOLID: Patient-Reported Outcome
impacts, contradicting previous opinion that PIB may in-
and Quality of Life Instruments Database; VAS: Visual analogue scale;
hibit ADHD adolescents’ ability to self report [21]. The WFIRS-S: Weiss Functional Impairment Rating Scale–Self.
results from the cognitive interviews were then used to
refine the new PRO instrument. Competing interests
The new instrument can be used to capture the adoles- MM and JS are employees of Shire. MHE was an employee of Shire at the
cent perspective of the impact of ADHD on functioning. It time of the study. AH, RP and AS were all employees of Evidera (formerly a
division of United BioSource Corporation) at the time of the study. Evidera
can also supplement traditional clinical assessments used received financial support from Shire to complete this manuscript. Shire
to monitor adolescents’ experiences in clinical setting, as manufactures and distributes drugs for the treatment of ADHD.
Hareendran et al. Health and Quality of Life Outcomes (2015) 13:133 Page 14 of 14

Authors’ contribution 11. Adler LA, Shaw DM, Spencer TJ, et al. Preliminary examination of the
AH served as the Principal Investigator, overseeing the direction of the reliability and concurrent validity of the attention-deficit/hyperactivity
project, reviewing all results and developing the instrument. AH, MHE and JS disorder self-report scale v1.1 symptom checklist to rate symptoms of
conceived the study and participated in its design. AH, RP and AS attention-deficit/hyperactivity disorder in adolescents. J Child Adolesc
participated in the implementation of the project by designing the study Psychopharmacol. 2012;22(3):238–44.
protocols, collecting data, analysing the results and developing and testing 12. Conners K. Conners’ Rating Scales-Revised. North Tonawanda, NY: Multi-
the instrument. JS and MHE also participated in the development and Health Systems, Inc.; 2001.
revisions of the instrument. MM participated in the study by providing 13. Achenbach TM. Commentary: Definitely more than measurement error: but
clinical expertise for protocol design and instrument development, as well as how should we understand and deal with informant discrepancies? J Clin
reviewing and approving drafts of the manuscript. All authors read and Child Adolesc Psychol. 2011;40(1):80–6.
approved the final manuscript. MHE was an employee of Shire at the time 14. Malekpour M. Effects of attachment on early and later development.
the study was conducted and the manuscript completed. Br J Develop Disabilities. 2007;53(105):81–95.
15. European Medicines Agency. Guideline on the clinical investigation of
medicinal products for the treatment of attention decifit hyperactivity
Acknowledgements
(ADHD) In: European Medicines Agency. London, UK. 2010. Available from:
The Authors thank the site staff who assisted with patient recruitment, Emily
http://www.ema.europa.eu/docs/en_GB/document_library/
Sargent who assisted with formatting and production, and the following
Scientific_guideline/2010/08/WC500095686.pdf.
staff who assisted with implementing and running the study: Laurie Roberts,
16. US Food and Drug Administration. Guidance for Industry on Patient-
MPH; Christina Vernon, MPH; all acknowledged staff were employees of
Reported Outcome Measures: Use in Medical Product Development to
Evidera (formerly a division of United BioSource Corporation) at the time of
Support Labeling Claims. Federal Register. 2009;74(235):65132-65133.
the study, served as paid consultants to Shire during the conduct of this
17. Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity-establishing and
study and the development of this manuscript. Caudex (Oxford, UK,
reporting the evidence in newly developed patient-reported outcomes
supported by funding from Shire International GmbH) is thanked for editorial
(PRO) instruments for medical product evaluation: ISPOR PRO Good
assistance and coordination and comments collation of this manuscript.
Research Practices Task Force report: part 2-assessing respondent
understanding. Value Health. 2011;14(8):978–88.
Funding 18. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative
This study was funded by Shire Development, LLC. Authors AH, RP and AS research (COREQ): a 32-item checklist for interviews and focus groups.
all employees of Evidera (formerly a division of United BioSource Int J Qual Health Care. 2007;19(6):349–57.
Corporation) at the time of the study, served as paid consultants to Shire 19. Pokrzywinski R, Setyawan J, Khan S, Erder MH, Hodgkins P, Hareendran A.
during the conduct of this study and the development of this manuscript. Development of a conceptual disease model to inform strategy to evaluate
treatment impact in adolescents with attention deficit hyperactivity disorder
Author details (ADHD). Presented at: 18th International Society for Pharmacoeconomics and
1
Outcomes Research, Evidera, London, UK. 2Global Health Economics Outcomes Research Annual Meeting, New Orleans, USA, May 18–22 2013.
Outcomes Research, Shire, Wayne, PA, USA. 3Outcomes Research, Evidera, 20. Setyawan J Hareendran A, Erder MH, Hodgkins P, Trundell D, Pokrzywinski R.
Bethesda, MD, USA. 4Shire Global Medical Affairs, Shire, Wayne, PA, USA. Measuring functioning in adolescents with ADHD. Do existing tools reflect
5 the adolescents’ perspective? Paper presented at: 4th World Congress on
Global Health Economics and Epidemiology, Shire, Wayne, PA, USA
(Affiliation at the time of the study). ADHD, 2013; Milan, Italy.
21. Owens JS, Goldfine ME, Evangelista NM, Hoza B, Kaiser NM. A critical review
Received: 12 December 2014 Accepted: 14 July 2015 of self-perceptions and the positive illusory bias in children with ADHD. Clin
Child Fam Psychol Rev. 2007;10(4):335–51.
22. Matza LS, Patrick DL, Riley AW, et al. Pediatric patient-reported outcome
instruments for research to support medical product labeling: report of the
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