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Bab I
Bab I
Abstract
Objective. To design and test the relia- though several questions were more rel-
bility and validity of a brief, treat- evant to type 1 or type 2 diabetes. For
ment-focused version of the Diabetes patients with type 1 diabetes, the 15-
Quality of Life (DQOL) questionnaire item brief inventory was equally or
for use with both type 1 and type 2 more effective at predicting self-care
diabetes. behaviors (shortened scale R2 = 0.360;
full scale R2 = 0.254) and satisfaction
Research design and methods. with diabetes control (shortened scale
Questionnaire packets including the R2 = 0.562; full scale R2 = 0.580) than
DQOL, measures of current diabetes the original 60-item DQOL. For type 2
self-care behaviors, and demographic diabetic patients, only satisfaction with
and health characteristics were mailed diabetes control was well-predicted, but
to 1,080 adults with type 1 or type 2 the 15-item inventory accounted for as
diabetes. A total of 498 patients much variance as the original 60-item
returned completed packets. A three- DQOL (shortened scale R2 = 0.513; full
stage statistical process was used to scale R2 = 0.492).
understand the underlying structure of
the DQOL and to identify items most Conclusions. The 15-item DQOL
predictive of self-care behaviors and Brief Clinical Inventory provides a
satisfaction with diabetes control. total health–related quality of life
score that predicts self-reported dia-
Results. Principal components analy- betes care behaviors and satisfaction
sis, conducted on 26 items predictive with diabetes control as effectively as
of the main criteria, identified five key the full version of the instrument. In
underlying factors. For each compo- addition, it provides a vehicle for
nent, best subset regression analysis quickly screening patients for readi-
was conducted to identify nonredun- ness and specific treatment-related
dant questions that best explained concerns. It takes about 10 minutes to
self-care behaviors and satisfaction administer and can be used to identify
with diabetes control. quality of life issues that might not
A combined set of 15 questions was arise during the typical patient-
reliable (alpha = 0.85) and valid, provider encounter.
perceptions of health and well-being.5,10 such as the Medical Outcomes Study whereas the Diabetes-Specific Quality-
Such low correlations have been report- SF-36,35 short hypertension-specific of-Life Scale is only validated for type
ed in several chronic diseases including QOL form,36 short coronary artery 1 diabetes.46 The Diabetes Quality of
diabetes, asthma, and chronic obstruc- disease–specific QOL form,37 and Life Clinical Trial Questionnaire47 and
tive pulmonary disease.9,11–13 short mental-health SF-36,38 have Diabetes-3948 were developed specifi-
The issue of HRQOL is particular- been successfully developed, in which cally for clinical trials in diabetes.
ly important for diseases such as dia- the goal was to preserve the full item More recently, an individualized mea-
betes, for which the health care regi- content range, scale structure, relia- sure, the Audit of Diabetes-Dependent
men requires ongoing self-care behav- bility, validity, and responsiveness of QOL, has been designed wherein
iors that can interfere with patients’ the original instruments.39 Outcome- respondents rate only personally
desired lifestyles. Providing optimal predictive QOL inventories have been applicable life domains.49,50 While this
diabetes care involves recognizing the successfully implemented with other measure is applicable to both type 1
inherent cost-benefit trade-off specific health problems, such as and type 2 diabetes, it lacks generaliz-
between the disease and treatment hypertension,40 arthritis,41 and mental ability due to its individualized nature.
burden. The Diabetes Control and health.38 Our goal, and consequently Other instruments, such as the 15-D
Complications Trial (DCCT) hinted at our analytical approach, differed Health Related Quality of Life mea-
this delicate balance by finding that somewhat from this. We focused on sure,51 were developed abroad and
intensive insulin therapy yielded a sig- selecting items that differentiate have not been validated for use with
nificant reduction in diabetic compli- patients in terms of treatment satis- American patients.
cations compared to traditional faction and compliance. Items most The DQOL questionnaire, devel-
insulin therapy,14 but did not lead to predictive of these two criteria were oped for both type 1 and type 2 dia-
improved quality of life.15 Other retained to build a clinical inventory betes as part of the DCCT,18,27,52 was
research has yielded inconsistent rela- that highlights clinically significant identified through our review as hav-
tionships between therapy intensity patient problems. ing qualities most amenable to aiding
and quality of life,16–26 in part because provider-patient communication
of the fact that HRQOL is influenced RESEARCH DESIGN AND about treatment. Despite desirable
by a myriad of other factors, such as METHODS content focus, reliability, and
the existence of other health prob- validity,52 the DQOL in its full form is
lems, social relationships, marital sta- Overview too lengthy to be completed as part of
tus,7,22,27 patient knowledge,28 treat- First, we reviewed the literature for a provider’s routine office visit. Its 46
ment satisfaction,18 and perceived diabetes-specific QOL measures, and core items measure four domains
ability to control one’s disease.7 these instruments were reviewed for highly relevant to treatment percep-
For health care professionals, a key comprehensiveness and psychometric tions: satisfaction with treatment,
goal in treating diabetes is to help properties. Based on this review, we impact of treatment, worry about the
patients improve their quality of life selected the Diabetes Quality of Life future effects of diabetes, and worry
by identifying and addressing dia- (DQOL) questionnaire to be our foun- about social/vocational issues.
betes-related issues. Past research has dation instrument. Second, a panel of
found, however, that as much as 54% experts in diabetes care reviewed the Procedure
of patient problems and 45% of DQOL for comprehensiveness. Third, We identified 1,080 potential partici-
patient concerns are neither elicited by we administered this instrument, along pants from a registry of people receiv-
providers nor disclosed by patients with a measure of current health care ing health care for type 1 or type 2
during a typical office visit.29 Along behaviors and demographic character- diabetes at a large midwestern acade-
these same lines, patients often istics, to 1,080 adults with type 1 or mic medical center. A packet contain-
express dissatisfaction with the infor- type 2 diabetes. Fourth, we analyzed ing an invitation letter (from the chief
mation provided to them by their this data to identify those survey items diabetes physician), questionnaire,
providers,29,30 and this patient- that best predict regimen adherence and stamped return envelope was
provider communication is linked to and satisfaction with the diabetes regi- mailed to each potential participant’s
patient compliance with therapy31 and men. These items became the core of home. Reminder letters were mailed
satisfaction with care.32,33 Findings the shortened DQOL instrument. to nonresponders 2 weeks later, and
also suggest that improving patient- Finally, we conducted analysis to eval- follow-up phone calls were made after
provider communication benefits uate the statistical performance of this 3 weeks to encourage participation.
patient health and promotes provider shortened instrument. Of the 1,080 potential participants,
loyalty as a consequence of improved 498 returned their survey packets for
satisfaction with care.34 Selection of the DQOL a total participation rate of 48%.
The objective of this study was to Current HRQOL instruments tend to
develop a valid and reliable, but be lengthy and often lack applicability Instruments
brief, diabetes-specific HRQOL to both type 1 and type 2 diabetic
instrument for use in routine office patients, making them difficult to inte- DQOL instrument
visits, with specific actionable items grate into routine clinical practice.42 The original DQOL is a 60-item
to improve provider-patient commu- For example, the Diabetes Care instrument to assess the diabetes-relat-
nication, treatment compliance, and Profile43,44 and the Diabetes Treatment ed QOL of participants. Of these
health care satisfaction. Recent short- Satisfaction Questionnaire45 are items, 13 are limited to children and
form quality of life (QOL) measures, applicable to type 2 diabetes only, adolescents with diabetes. The instru-
42
Diabetes Spectrum Volume 17, Number 1, 2004
Feature Article/Burroughs et al.
ment provides an overall scale score, viding information about their sex, control satisfaction and reported
as well as four subscale scores for 1) age, marital status, education, self-care. The two-step approach
satisfaction with treatment, 2) impact income level, type of diabetes, length allowed us to reduce redundancy
of treatment, 3) worry about the of time since diagnosis of diabetes, among items that were highly corre-
future effects of diabetes, and 4) presence of specific diabetic compli- lated with each other before trying
worry about social/vocational issues. cations, and presence of other specif- to explain maximal combined vari-
Items are scored on a 5-point ic health problems. ance from all unique sources of vari-
Likert scale and are of two general ation in the instrument.
formats. One format asks about the Statistical Analyses
frequency of negative impact of dia- The DQOL responses were ana- RESULTS
betes itself or of the diabetes treat- lyzed in three stages to reduce the
ment (i.e., “How often do you worry number of items while maximizing Sample Characteristics
about whether you will pass out?”) prediction of the criteria. In the Of the 498 respondents, 32% had
and provides response options from 1 first stage, we assessed the compa- type 1 diabetes, and 68% had type 2
(never) to 5 (all the time). The second rability of our data to the original diabetes. Length of time since diagno-
format asks about satisfaction with DQOL validation study52 by com- sis ranged from 1 to more than 20
treatment and quality of life (i.e., paring means, standard deviations, years, with a median length of time of
“How satisfied are you with the time variances, and coefficient alphas 8 years. Slightly more than half the
you spend exercising?”) and is scored for the four original DQOL scales. respondents were female (53%), and
from 1 (very satisfied) to 5 (very dis- In the second stage, we conducted ages for respondents ranged from 21
satisfied). Higher scores on DQOL an initial item analysis in which to more than 80 years, with a median
items and subscales are, therefore, frequency distributions and the of 51 years. Educational levels ranged
negatively valenced, indicating prob- Pearson product-moment correla- from a completed doctoral to less
lem frequency or dissatisfaction. The tion with the two criteria were cal- than a high school degree, with 41%
instrument has been shown to have culated for each of the 46 original having completed just a high school
excellent internal consistency (r = adult DQOL items. Items which degree. Annual household income
0.78–0.92), test retest reliability (r = had a Pearson correlation of at ranged from less than $15,000 to
0.78–0.92), and convergent validity least 0.25, were statistically signifi- more than $100,000, with a median
for all four subscales for people with cant and considered clinically rele- of $37,500. In examining respon-
type 1 and type 2 diabetes.18,27,52 vant. Twenty-six items met this cri- dents’ health status, subjects reported
teria and were retained for stage 3 a number of health problems includ-
Concurrent criteria analyses. ing hypertension (51%), high choles-
Current levels of health care behav- In the third stage, we identified terol (45.3%), arthritis (42.4%),
iors. Participants completed a five- optimal subsets of items for type 1 sleeping problems (44.6%), and
item questionnaire assessing how and type 2 diabetes. First, we per- depression (33.3%).
frequently they engaged in the fol- formed principal components analy-
lowing self-care behaviors: 1) diet, 2) sis on the 26 predictive items for Comparison of Data With DQOL
insulin, 3) exercise, 4) foot care, and the entire participant sample. Validation Sample
5) blood glucose monitoring (identi- Several orthogonal rotations were Stage 1 of the analysis directly com-
fied by the American Diabetes examined, with varimax rotation pared our results to those of the orig-
Association as critical for good yielding the clearest separation of inal validation study52 to assess
metabolic control). Each behavior factor loadings. We then used mul- whether there were differences in the
was scored on a Likert scale ranging tiple linear regression to model 1) HRQOL issues faced by these two
from 1 (never) to 5 (always) and diabetes control satisfaction and 2) samples. Our sample reported lower
then averaged to create a total mea- reported self-care as a function of overall diabetes-related quality of
sure of self-care (higher = greater fre- the groups of items from the five life, but worried less about social/
quency of adherence to self-care DQOL components. vocational issues than did the valida-
guidelines). The instrument used in Models were built separately in a tion sample. The mean DQOL total
this study was based largely on two-step process for type 1 and type score of 2.6 (SD = 0.7) for males in
instruments that have been widely 2 diabetes. In the first step, we used this sample was significantly higher
used in diabetes research.53,54 stepwise selection to identify items (indicating lower QOL) than the
from each orthogonal principal mean score of 2.0 (SD = 0.4) for the
Overall treatment satisfaction. component that explained signifi- previous sample, (t = 7.336, P <
Respondents were asked to rate their cant variance in either diabetes con- 0.0001). Similarly, the mean DQOL
overall “satisfaction with diabetes trol satisfaction or reported self- total score for women of 2.7 (SD =
control” based on their current treat- care. In the second step, we used 0.8) was significantly higher (indicat-
ment. Responses were made on a best 1–10 variable subset methods ing lower QOL) than the previous
Likert scale ranging from 1 (very satis- with the joint set of items identified sample mean score of 2.1 (SD = 0.4)
fied) to 5 (very unsatisfied). in the first step to identify items that (t = 5.336, P < 0.0001). No differ-
jointly and most parsimoniously ences between the two samples were
Patient background questionnaire (based on Schwarz’s BIC and observed for worry about diabetes-
Participants also completed an eight- Mallow’s C) explained the maxi- related events, or for females for dia-
item demographic questionnaire pro- mum amount of variance in diabetes betes impact.
43
Diabetes Spectrum Volume 17, Number 1, 2004
Feature Article/DQOL Brief Clinical Inventory
DQOL reliability coefficients in our demonstrated clean separation of avoid telling others about diabetes,
sample were comparable to the valida- components, with only three items frequency of career limitation, and
tion study,52 ranging from 0.61 for the demonstrating minor cross-loadings, frequency of worry over passing out.
Diabetes Worry subscale to 0.94 for and only one item failing to load with Regression analyses were next con-
the total DQOL scale score. Detailed a correlation of at least 0.40 onto any ducted to evaluate how well the six-
examination of missing values indicat- component. and nine-item models predicted satis-
ed few problems with only two items faction and self-care, compared to
(Impact Q25 [9%] and Impact Q21 Type 1 diabetes models containing all 60 DQOL
[10%]) having missing value rates as Six items were identified by the two- items. In predicting satisfaction with
high as 10%. Further, there were no stage regression analysis as predictors treatment, the six-item model had an
items for which more than 90% of of satisfaction with diabetes control (P adjusted R2 of 0.562, compared to
respondents selected the lowest < 0.0001). These items included satis- 0.580 for the 60-item model. In pre-
response option, which would have faction with the time spent managing dicting self-care behaviors, the six-
suggested that the item did not pose a diabetes, satisfaction with current item model had an adjusted R2 of
quality of life issue for our sample. treatment, satisfaction with sex life, 0.360, compared to 0.254 for the 60-
frequency of bad sleep, frequency of item model. These results suggest that
Item Selection career limitation, and frequency of six- and nine-item solutions are effec-
In Stage 2, we identified 26 items pre- worry over missing work. Table 2 tively able to predict overall satisfac-
dictive of self-care and satisfaction provides regression parameters. tion with diabetes control and overall
with diabetes control. In stage 3, we Similarly, nine items were identified self-care behaviors as well as the full
used principal components analysis55 as predictors of self-care adherence (P 60-item survey among patients with
to identify groups of items with over- < 0.0001). These items included satis- type 1 diabetes.
lapping content. This step yielded five faction with glucose maintenance, sat-
significant principal components that isfaction with current treatment, satis- Type 2 diabetes
accounted for 9.23–15.35% of the faction with burden on family, satis- The results differed for type 2 dia-
total item variance each and 56.73% faction with exercise, frequency of betes. Six items were identified as pre-
of the total item variance collectively. pain with treatment, frequency of feel- dictors of satisfaction with diabetes
The solution, shown in Table 1, ing ill, frequency of breaking diet to control (P < 0.0001). These items
44
Diabetes Spectrum Volume 17, Number 1, 2004
Feature Article/Burroughs et al.
included satisfaction with the time tion with treatment, the six-item cant in more than one of the previous
spent managing diabetes, satisfaction model had an adjusted R2 of 0.513, regression models). A total scale score
with checkups time, satisfaction with compared to 0.492 for the 60-item was calculated for this shortened scale
current treatment, satisfaction with model. In predicting self-care behav- based on regression weights. The new
exercise time, frequency of pain with iors, the six-item model had an adjust- inventory showed good internal con-
treatment, and frequency of worry ed R2 of 0.117, compared to 0.196 for sistency (alpha = 0.85).
over passing out. Similarly, six items the 60-item model. These results sug- The new total score was correlated
were identified as predictors of self- gest that, for type 2 diabetes, overall with the full DQOL scale and with
care adherence (P = 0.0075). These satisfaction with diabetes control was the individual DQOL subscales. The
items included satisfaction with glu- predicted as well by the six-item sur- uncorrected correlation between the
cose maintenance, satisfaction with vey as by the 60-item survey, though two total scales was 0.81, and correla-
diabetes knowledge, satisfaction with overall self-care behaviors were pre- tion corrected for attenuation due to
exercise time, frequency of breaking dicted slightly better by the overall 60- the instrument’s reliability was 0.91,
diet to avoid telling others about dia- item model than by the six-item suggesting that the shortened version
betes, frequency of worry over miss- reduced model. was able to explain the vast majority
ing work, and frequency of worry of variation in total DQOL scores.
over passing out. Constructing the DQOL Short-Form Equivalent analysis suggested that
Regression analyses evaluated how Clinical Inventory the shortened scale correlated strongly
well these six-item models predicted These four sets of items (two each with each of the individual subscales
satisfaction and self-care, as compared from type 1 and type 2 diabetes analy- from the full instrument. The strongest
to models that contained all 60 ses) were then combined into a master relationship was with the satisfaction
DQOL items. In predicting satisfac- 15-item set (several items were signifi- subscale (uncorrected r = 0.84 and
45
Diabetes Spectrum Volume 17, Number 1, 2004
Feature Article/DQOL Brief Clinical Inventory
reliability, predictive validity for clini- Cardiovasc Care 4:103–126, 1988 Patrick DL, Taylor TR, Tse CK: Disease-specific
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