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1. Monitoring and Discussing Health-Related Quality of Life in Adolescents With Type 1 Diabetes Improve
Psychosocial Well-Being: A randomized controlled trial………………………………………………………………………. 1
…………………………………………………………………………………………………………………………………… 11
28 October 2013 ii ProQuest
Document 1 of 1
Monitoring and Discussing Health-Related Quality of Life in Adolescents With Type 1 Diabetes
Improve Psychosocial Well-Being: A randomized controlled trial
Author: de Wit, Maartje; de Waal, Henriette A Delemarre-van; Bokma, Jan Alle; Haasnoot, Krijn; Houdijk, Mieke
C; Gemke, Reinoud J; Snoek, Frank J
Publication info: Diabetes Care 31.8 (Aug 2008): 1521-6.
ProQuest document link
Abstract: To test the effects of monitoring and discussing of health-related quality of life (HRQoL) in adolescents
with type 1 diabetes in a multicenter randomized controlled trial. Four centers were randomly assigned to the
HRQoL intervention (46 adolescents) or control (45 adolescents) group, with three regular visits scheduled
within 12 months in both groups. In the HRQoL intervention group, HRQoL of adolescents was assessed using
the Pediatric Quality of Life Inventory, and outcomes were discussed face-to-face during the consultation. The
control group received care as usual. Mean differences between the groups at 12 months in physical and
psychosocial well-being (Child Health Questionnaire [CHQ]-CF87/PF50, Diabetes-Specific Family Conflict
Scale, and Center for Epidemiological Studies Scale for Depression), satisfaction with care (Patients’ Evaluation
of the Quality of Diabetes Care), and A1C were determined, controlling for baseline scores. Mean scores on the
CHQ subscales of psychosocial health (P <0.001), behavior (P <0.001), mental health (P <0.001), and family
activities (P <0.001) improved in the HRQoL intervention group, except for adolescents with the highest A1C
values. Adolescents in the HRQoL intervention group reported higher self-esteem (CHQ) at follow-up (P =
0.016), regardless of A1C, and were more satisfied with care (P = 0.009) than control subjects. No significant
differences between the two groups over time were observed in A1C levels. Periodic monitoring and discussion
of HRQoL in adolescents with diabetes is appreciated and has positive effects on their psychosocial well-being,
except for those in poorest control.
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Full text: Headnote
OBJECTIVE - To test the effects of monitoring and discussing of health-related quality of life (HRQoL) in
adolescents with type 1 diabetes in a multicenter randomized controlled trial.
RESEARCH DESIGN AND METHODS - Four centers were randomly assigned to the HRQoL intervention (46
adolescents) or control (45 adolescents) group, with three regular visits scheduled within 12 months in both
groups. In the HRQoL intervention group, HRQoL of adolescents was assessed using the Pediatric Quality of
Life Inventory, and outcomes were discussed face-to-face during the consultation. The control group received
care as usual. Mean differences between the groups at 12 months in physical and psychosocial well-being
(Child Health Questionnaire [CHQ]-CF87/PF50, Diabetes-Specific Family Conflict Scale, and Center for
Epidemiological Studies Scale for Depression), satisfaction with care (Patients' Evaluation of the Quality of
Diabetes Care), and A1C were determined, controlling for baseline scores.
RESULTS - Mean scores on the CHQ subscales of psychosocial health (P <0.001), behavior (P <0.001), mental
health (P <0.001), and family activities (P <0.001) improved in the HRQoL intervention group, except for
adolescents with the highest A1C values. Adolescents in the HRQoL intervention group reported higher self-
esteem (CHQ) at follow-up (P = 0.016), regardless of A1C, and were more satisfied with care (P = 0.009) than
control subjects. No significant differences between the two groups over time were observed in A1C levels.
CONCLUSIONS - Periodic monitoring and discussion of HRQoL in adolescents with diabetes is appreciated
and has positive effects on their psychosocial well-being, except for those in poorest control.
Diabetes Care 31:1521-1526, 2008
28 October 2013 Page 1 of 11 ProQuest
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Hormonal and psychosocial changes related to puberty can seriously complicate diabetes regulation. Indeed,
adolescents with type 1 diabetes as a group display the worst glycemic control compared with other age-groups
(1,2). From a developmental perspective, the daily demands of self-regulation can interfere with adolescents’
normal routines and friendships, thereby compromising their emotional and social well-being (3). Moreover,
teenagers tend to give high priority to fulfilling their psychosocial needs here and now rather than taking
preventive action to avoid health risks long term (4). Attaining good health-related quality of life (HRQoL) as well
as strict glycemic control is a challenge for adolescents with diabetes, their families, and health care providers.
Periodic evaluation and discussion of the adolescents’ HRQoL as an integral part of diabetes care is
recommended to ensure recognition of the teenagers’ perspective, identify psychosocial barriers, and promote
healthy coping (5,6). The utility of such an approach has not been tested in pediatric diabetes, but was shown to
be beneficial in pediatric rheumatic patients as well as adult diabetes and cancer patients (7-9). We set out to
test the effects of systematic monitoring and discussion of HRQoL of adolescents with type 1 diabetes in a
randomized controlled trial. We hypothesized this would have a positive effect on the well-being and satisfaction
with care of the adolescents, subsequently improving self-care and glycemic control.
RESEARCH DESIGN AND METHODS
Participants in the age range of 13-17 years were recruited from four pediatric diabetes clinics in the
Netherlands. Clinics were selected based on willingness to participate, number of patients, and similar clinical
routines. Exclusion criteria were as follows: diabetes duration <6 months, mental retardation, and not fluent in
the Dutch language. The study was approved by the medical ethical committees of the participating centers;
written informed consent was obtained from patients and parents.
Design
After a baseline assessment of demographics, diabetes duration, and treatment regimen, the four outpatient
clinics were randomly assigned to either the control or HRQoL intervention group. There were seven
pediatricians in the HRQoL intervention and six in the control group. Center rather than patient randomization
was used to avoid contamination at the pediatricians' level. During the 12-month study period, all adolescents
had three regular appointments at 3-month interval. At each consultation, data were gathered on height, weight,
A1C levels, and treatment regimen.
Power calculations, taking into account the intercluster correlation (ρ = 0.006), indicated that a difference of five
points in mean well-being (range 0-100 and SD = 11) and a difference of 0.5% in mean A1C (SD = 1.1) at a 5%
significance level with 80% power could be detected with 21 adolescents in each cluster (hospital) and thus 42
in each group.
HRQoL intervention group
The HRQoL intervention consisted of two parts: 1) monitoring the HRQoL right before the 3-month appointment
with the pediatrician and 2) discussion of the HRQoL scores with the teenager during the appointment. The
adolescents completed the Pediatric Quality of Life Inventory (PedsQL) Generic and PedsQL Diabetes-specific
modules on a computer before the consultation with their pediatrician. The generic module of the PedsQL
comprises a Physical and Psychosocial subscale. The latter consists of an Emotional, Social, and School
subscale (10).
The Diabetes module contains items on symptoms, treatment barriers, treatment adherence, worries, and
communication (11). A total of 51 questions were answered on a five-point Likert scale. The computer program
automatically calculated the subscale scores of the PedsQL, between O and 100, with higher scores
representing better HRQoL. Reports with the outcomes of the PedsQL were printed for the pediatrician and the
adolescent to be discussed during the consultation.
Before the study, pediatricians had received a short training on how to interpret and discuss HRQoL scores and
were offered a small guide with instructions and a list of the individual items of each PedsQL subscale as a
backup for discussing PedsQL scores.
28 October 2013 Page 2 of 11 ProQuest
Pediatricians were instructed to start with discussing Generic PedsQL scores, with Dutch norm scores as
reference, and respectfully invite the adolescent to comment and discuss the outcomes. Thereafter, the
Diabetes-specific subscales of the PedsQL were discussed, exploring possible solutions and actions.
Pediatricians were asked to fill out a checklist to document topics and decisions. At the following (second and
third) appointments, the pediatrician and adolescent could track and discuss changes in PedsQL scores over
time (if any).
Patients and parents were informed at the start of the study that parents were welcome to join the consultation
during the last 10 min and of course could be present during the whole consultation if so wished by patient and
parent.
Control group
The adolescents received care as usual in the control group. To control for answering questions on the
computer before the consultation, adolescents completed a lifestyle questionnaire instead of an HRQoL
questionnaire on the computer, with items on eating, drinking, leisure activities, sports, and friends. Patients in
the control group were informed that the outcomes of this measurement were not to be discussed during the
consultation or thereafter.
Outcome measures
Baseline and follow-up assessment took place separate from the clinical appointments. Before the first
appointment, baseline measures were assessed by sending adolescents and parents a questionnaire booklet
on physical and psychosocial well-being to their home address. After the third appointment, a similar booklet
was sent again and returned to the research team. Parent data will be reported elsewhere.
Physical and psychosocial well-being. Physical and psychosocial well-being of the adolescents was measured
using the 87-item child report version of the Child Health Questionnaire (CHQ) (CHQ-CF87), covering domains
of physical, emotional, social, and mental health, rated over the previous 4 weeks (12). Scores are standardized
to 0-100, with higher scores indicating better well-being.
Depression. Depressive symptomatology was assessed with the 20-item Center for Epidemiological Studies
scale for Depression (CES-D) (13). Items are scored on the basis of frequency of depressive symptoms
reported in the past week, from O (never) to 3 (daily). Total CES-D scores range between 0 (no depressive
symptoms) to 60 (most frequent/severe depressive symptoms).
Diabetes-specific family conflict. As previous studies have shown that family conflicts contribute to poor well-
being and glycemic control (14,15), we decided to assess the amount of Diabetes-specific family conflicts with
the revised version of the Diabetes-Specific Family Conflict Scale (DFCS). The DFCS assesses the degree of
family conflict on 19 management tasks, rated on a 3-point scale (14). Scores range from 19 (minimum) to 57
(maximum).
Satisfaction with care. The Patients’ Evaluation of the Quality of Diabetes Care (PEQ-D) assesses the patients’
judgment about the quality of diabetes care over the past 12 months (16). An example item is “the clarity of the
information I receive from my doctor.” Items are scored on a five-point Likert scale and summated to calculate
overall Quality of Care score, ranging from O to 100 (poor to optimal quality of diabetes care).
Glycemic control. Glycemic control was assessed by AlC values that were retrieved from the charts, using the
assessment closest to the date of completion of the booklets.
Statistical analysis
Scoring and substitution of missing values was performed according to manuals (12,17). For the CHQ, in the
case of <50% missing data per subscale, substitution of the mean was used. For the CES-D and DFCS, we
substituted missing data with the mean if <25% of the data were missing. None of the patients had over 25%
missing data.
After exploring the change in scores from baseline to follow-up for each group with a paired t test or Wilcoxon's
signed-rank test in case of non-normality, repeated-measures ANOVA analyses using general linear modeling
28 October 2013 Page 3 of 11 ProQuest
in SPSS 14.0 were used. The effect of the HRQoL intervention was compared with that of the control group on
physical and psychosocial well-being, satisfaction with care, and glycemic control, controlling for baseline levels
and baseline characteristics (age, sex, center, ethnic minority, family structure, diabetes duration, and treatment
regimen). Multilinear regression analysis was used to examine the possibility of interaction and confounding
effects of demographic and diabetes-related variables with the HRQoL intervention and control group.
First, the effect of the HRQoL intervention on the physical and psychosocial health summary and subscale
scores was examined, controlling for its baseline score. In the next step, demographic (sex, age, center, ethnic
minority, and family structure) and diabetes-related variables (diabetes duration, AlC, and treatment regimen),
as well as interaction terms with the groups, were added to correct for possible confounders and maintained in
the model if significant.
RESULTS- The trial profile is depicted in Fig. 1. Of the 171 patients meeting inclusion criteria, 91 (53%) agreed
to participate. Baseline characteristics of the study sample have been reported in detail elsewhere (18). There
were no differences between participants and nonparticipants in sex, age, diabetes duration, or glycemic
control. Ten adolescents (five in each group) were lost to follow-up during the year because of transfer to other
diabetes specialists or no-show. Those who dropped out had higher A1C levels at baseline than participants
(9.9% vs. 8.7%, P = 0.02). There were no other differences in demographic and psychosocial variables. The
final sample contained 81 patients: 41 in the HRQoL intervention group and 40 in the control group (Table 1). At
baseline, there were no significant differences between the four clinics or between the HRQoL intervention and
control group.
Physical and psychosocial health
Main effects. Physical and psychosocial well-being scores for the HRQoL intervention and control group at
baseline and follow-up are shown in the online appendix Al (available at http://dx.doi.org/ 10.2337/dc08-0394).
General linear modeling repeated-measure analyses with correction for baseline levels showed a significant
28 October 2013 Page 4 of 11 ProQuest
effect of group over time for the Psychosocial health summary scale of the CHQ-CH87 (P = 0.006) (Fig. 2A).
This effect was mainly due to an improvement in the subscales Behavior (P = 0.007) and Self-Esteem (P =
0.016) for the HRQoL intervention group, while the scores remained unchanged for the control group.
Interaction effects. Linear regression analyses with inclusion of the interaction terms and possible confounders
revealed an interaction effect on the Psychosocial summary scale between the study groups and baseline AlC
level (R^sup 2^ = 0.382, P <0.001). For lower AlC levels, scores of the HRQoL intervention group improved,
whereas they remained stable in the control group. Closer inspection of the subscales revealed a significant
interaction effect for the subscales Behavior (R^sup 2^ = 0.562, P <0.001), Mental Health (R^sup 2^ = 0.404, P
<0.001), and Family Activities (R^sup 2^ = 0.370, P <0.001). For adolescents with highest AlC values (>9.5%),
however, there was no difference between baseline and follow-up scores in the HRQoL intervention (or control)
group. For the Self-Esteem subscale, we found that scores improved for the HRQoL intervention group between
baseline and follow-up, regardless of A1C values (R^sup 2^ = 0.382, P <0.001).
No differences over time between the two groups on Physical Health, family conflicts (DFCS), or depression
(CES-D) were observed.
Satisfaction with care
Adolescents in the HRQoL intervention group reported to be more satisfied with their care (on the PEQ-D) at 1
year follow-up compared with the control group (P = 0.009) (Fig. 2B). This effect was independent of A1C,
demographic, and diabetes-related variables.
Glycemic control
At follow-up, mean A1C was 8.4 ±1.6% for the HRQoL intervention group and 8.3 ±1.3% for the control group,
with no significant difference between the groups in decline in AlC levels over time (P = 0.54).
Post hoc analyses
Change in PedsQL scores in relation to CHQ and PEQ-D scores at follow-up in the HRQoL intervention group.
To explore if the changes in PedsQL scores were related to CHQ-CF87 (well-being) and PEQ-D (satisfaction
with care) scores at follow-up, we used linear regression analyses, controlling for baseline CHQ scores. Change
in PedsQL treatment barrier scores were related to change in CHQ Behavior scores (R^sup 2^ = 0.612, P
<0.001; β treatment barriers = 0.218,P = 0.035), whereas change in the PedsQL Diabetes module total score
was related to the CHQ Self-Esteem subscale scores at follow-up (R^sup 2^ = 0.486, P <0.001, β total diabetes
= 0.478, P = 0.016). Change in the Emotional subscale scores of the PedsQL were related to CHQ Mental
health subscale scores at follow-up (R^sup 2^ = 0.409, P <0.001; β emotional = 0.316, P = 0.029).
Change in the PedsQL Psychosocial summary score (especially the Emotional and School subscales) was
associated with the Family activities subscale of the CHQ at follow-up (R^sup 2^ = 0.693, P <0.001; β
28 October 2013 Page 5 of 11 ProQuest
psychosocial = 0.514, P = 0.026).
PEQ-D scores at follow-up were not predicted by change in PedsQL scores, suggesting that the reported
increased satisfaction with care was independent of changes in HRQoL.
Predictors of A1C at follow-up. Because we did not find a significant change in glycémie control, we collapsed
both groups to explore predictors for change in A1C levels. In a forward linear regression analysis, over 20% of
the variance in change in A1C was explained by baseline A1C levels and amount of family conflict (DFCS
scores) (R^sup 2^ = 0.204, P <0.001; [white square] baseline A1C = -0.391, P <0.001; [white square] DFCS =
0.057, P = 0.024). A1C explained 14.7% and DFCS scores explained an additional 5.6% of the variance in
change.
CONCLUSIONS- This is the first trial to demonstrate the positive effects of periodic assessment and discussion
of HRQoL in adolescents with type 1 diabetes as an integral part of diabetes outpatient care. At the 1-year
follow-up, patients in the HRQoL intervention group reported significantly fewer behavioral problems, improved
self-esteem and mental health, and increased participation in family activities. The adolescents in our study
reported relatively high levels of well-being at study entry (18), yet we achieved clinically relevant improvements
with effect sizes ranging between 0.36 (moderate) and 0.57 (large). Whether the same or larger effects can be
established in teenagers with a less favorable psychological profile remains to be seen.
Interestingly, we found that adolescents with relatively high A1C values at baseline (>9.5%) did not show
improvement (nor worsening) of psychosocial outcomes over time. This may reflect higher levels of complexity
in these adolescents or may be related to how PedsQL outcomes were discussed. In this group, pediatricians
may be inclined to focus on the importance of achieving strict glycemic control, putting less emphasis on
psychosocial issues. Unfortunately, we cannot verify whether such differences in communication occurred, as
we were not able to record the consultations. Examination of notes made by the pediatricians using a checklist
confirmed that HRQoL scores were discussed based on the assessment but not how that was done. Future
28 October 2013 Page 6 of 11 ProQuest
research should, if possible, include videotaping to observe the behavior of pediatricians and the interaction with
the adolescent.
The positive effect of the HRQoL intervention on psychosocial well-being was associated with neither
improvement nor worsening of glycemic control. AlC levels remained constant in both groups, in contrast to the
often-observed deterioration during puberty. This might be due to a study effect or a selection bias.
The HRQoL intervention was overall well appreciated by the adolescents, independent of their A1C and
whether or not there was improvement in psychosocial well-being. Adolescents indicated on the PEQ-D that
discussing HRQoL during the consultation helped the pediatricians to be more supportive and offered more
opportunities for shared decision-making. Moreover, no adverse effects of the monitoring procedure were
reported, in concert with previous studies in adult populations (7,8).
Some limitations of our study need to be mentioned. Selection bias may have affected our results, since about
half of the eligible patients decided not to participate in the registered clinical trial. Previous studies in the
adolescent population also showed large refusal rates (19,20). Poor glycemic control was obviously not a
reason for decline, and the variation among individual adolescents in physical and psychosocial well-being was
quite large. It is of note that the adolescents who dropped out of the study did have higher A1C levels at
baseline compared with the others.
Another limitation is the fact that we did not assess self-care behavior. We can therefore not exclude the
possibility that minor changes in self-management have occurred, although it is unlikely given the stable AlC in
both groups. In contrast to our expectation, the HRQoL intervention did not affect glycemic control. We should
acknowledge the fact that discussing HRQoL issues does not necessarily lead to talking about diabetes
mismanagement (e.g., insulin omission) and indeed pediatricians were not instructed to do so in our study. It
would seem worthwhile to test if adding a more focused assessment and discussion of self-care, using a
goaldirected “conversation map,” facilitates behavior change with subsequent improvements in glycemic control
(19).
In line with previous studies, family functioning, along with baseline AlC, proved to be an important determinant
of glycémie control at follow-up, with those having fewer family conflicts showing better outcomes (14,21). The
PedsQL has good psychometric properties and utility (22), but it contains only one question on family
functioning. Expanding the assessment of family functioning as part of periodic monitoring and discussion of
HRQoL in teenagers with diabetes should therefore be considered.
Based on a two- to threefold increased rate of depression among teenagers with diabetes (23,24), screening for
concurrent emotional problems is recommended in this age-group (5,6). However, in our study, only three
patients reported CES-D scores indicative of depression. Future studies should determine if the ‘ PedsQL is
suitable as a screener for depressive symptoms in adolescents or whether an additional depression screener is
needed. In more general terms, further research is needed to test whether systematic monitoring and
discussion of HRQoL can effectively help to detect psychological problems at an early stage, thereby preventing
further deterioration.
Little is known about the optimal frequency of monitoring HRQoL. The positive results in our study were
achieved by monitoring and discussing HRQoL every 3 or 4 months, linked to routine outpatient visits. Further
research should test whether less frequent monitoring, for example on an annual basis, produces the same
outcomes across different patient groups.
In sum, implementing a computerassisted HRQoL intervention in routine pediatric diabetes care is feasible, well
appreciated by adolescents and providers, and results in significant improvements in psychosocial well-being.
Acknowledgments- This study is supported by the Dutch Diabetes Research Foundation, gram 2003.00.020.
We thank all participating pediatricians and nurses from the following centers for their contribution: Medical
Center Alkmaar, Spaarne Ziekenhuis Hoofddorp, and Juliana Kinderziekenhuis Den Haag.
References
28 October 2013 Page 7 of 11 ProQuest
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AuthorAffiliation
MAARTJE DE WIT, MSC1-2
HENRIETTE A. DELEMARRE-VAN DE WAAL, MD, PHD3,4
JAN ALLE BOKMA, MD5
KRIJN HAASNOOT, MD6
MIEKE C. HOUDIJK, MD, PHD7
REINOUD J. GEMKE, MD PHD3
FRANK J. SNOEK, PHD1,2
AuthorAffiliation
From the 1 Department of Medical Psychology, VU University Medical Center, Amsterdam, the Netherlands; 2
EMGO Institute, VU University Medical Center, Amsterdam, the Netherlands; the 3 Department of Pediatrics,
VU University Medical Center, Amsterdam, the Netherlands; the 4 institute of Clinical and Experimental
Neurosciences, VU University Medical Center, Amsterdam, the Netherlands; the 5 Department of Pediatrics,
Spaarne Ziekenhuis, Hoofddorp, the Netherlands; the 6 Department of Pediatrics, Medical Center, Alkmaar, the
Netherlands; and the 7 Department of Pediatrics, Juliana Kinderziekenhuis, Den Haag, the Netherlands.
Corresponding author: Maartje de Wit, m.dewit@vumc.nl.
Received 25 February 2008 and accepted 14 May 2008.
Published ahead of print at http://care.diabetesjoumals.org on 28 May 2008. DOI: 10.2337/dc08-0394. Clinical
trial reg. no. ISRCTN65138334, www.ISRCTN.org.
©2008 by the American Diabetes Association. Readers may use this article as long as the work is properly
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.
org/licenses/by-nc-nd/3.0/ for details.
The costs of publication of this article were defrayed in part by the payment of page charges. This article must
therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this
fact.
Subject: Diabetes; Mental health; Quality of life; Teenagers;
MeSH: Adolescent, Conflict (Psychology), Depression — epidemiology, Diabetes Mellitus, Type 1 — drug
therapy, Family, Female, Focus Groups, Health Status, Humans, Hypoglycemic Agents — therapeutic use,
Insulin — therapeutic use, Insulin Infusion Systems, Male, Netherlands, Reference Values, Social Support,
Adolescent Psychology (major), Diabetes Mellitus, Type 1 — psychology (major), Quality of Life (major), Social
28 October 2013 Page 9 of 11 ProQuest
Adjustment (major)
Substance: Hypoglycemic Agents; Insulin;
Publication title: Diabetes Care
Volume: 31
Issue: 8
Pages: 1521-6
Number of pages: 6
Publication year: 2008
Publication date: Aug 2008
Year: 2008
Section: ORIGINAL ARTICLE
Publisher: American Diabetes Association
Place of publication: Alexandria
Country of publication: United States
Publication subject: Medical Sciences–Endocrinology
ISSN: 01495992
CODEN: DICAD2
Source type: Scholarly Journals
Language of publication: English
Document type: Journal Article
Document feature: Charts Graphs Tables References
Accession number: 18509204
ProQuest document ID: 223018853
Document URL:
http://ezp.waldenulibrary.org/login?url=http://search.proquest.com/docview/223018853?accountid=14872
Copyright: Copyright American Diabetes Association Aug 2008
Last updated: 2013-02-19
Database: ProQuest Central,ProQuest Nursing & Allied Health Source
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Bibliography
Citation style: APA 6th – American Psychological Association, 6th Edition
de Wit, M., de Waal, H.,A.Delemarre, Bokma, J. A., Haasnoot, K., Houdijk, M. C., Gemke, R. J., & Snoek, F. J.
(2008). Monitoring and discussing health-related quality of life in adolescents with type 1 diabetes improve
psychosocial well-being: A randomized controlled trial. Diabetes Care, 31(8), 1521-6. Retrieved from
http://search.proquest.com/docview/223018853?accountid=14872
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- Monitoring and Discussing Health-Related Quality of Life in Adolescents With Type 1 Diabetes Improve Psychosocial Well-Being: A randomized controlled trial
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