Symptom Burden of Cancer Patients: Validation of the German M. D. Anderson Symptom Inventory: A Cross-Sectional Multicenter Study

 
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Vol.   -   No.   - -   2014                                                Journal of Pain and Symptom Management 1

Brief Methodological Report

Symptom Burden of Cancer Patients:
Validation of the German M. D. Anderson
Symptom Inventory: A Cross-Sectional
Multicenter Study
Heike Schmidt, MD, Charles S. Cleeland, PhD, Alexander Bauer, PhD,
Margarete Landenberger, PhD, Prof, and Patrick Jahn, RN, PhD
Institute for Health and Nursing Science, Medical Faculty, Martin-Luther-University Halle-
Wittenberg (H.S., A.B., M.L., P.J.); The University of Texas M. D. Anderson Cancer Center (C.S.C.),
Houston, Texas, USA; and Nursing Research Unit, University Hospital Halle (Saale) (P.J.), Halle,
Germany

Abstract
    Context. Cancer patients frequently suffer from various symptoms often
impairing functional status and quality of life. To enable timely supportive care,
these symptoms must be assessed adequately with reliable tools.
    Objectives. This study aimed to validate the German version of the M. D.
Anderson Symptom Inventory (MDASI).
    Methods. This was a multicenter, cross-sectional, observational study. At five
German university hospitals, 697 cancer patients aged from 18 to 80 years
undergoing active anticancer treatment were recruited to participate in the study.
For the validation, reliability (Cronbach’s alpha), construct validity (factor
analysis), known group validity (Eastern Cooperative Oncology Group
Performance Status), and convergent divergent analyses were calculated.
    Results. Of the 980 patients who were eligible, 697 patients were included
and agreed to participate in the study (71%). Reliability analysis showed good
internal consistencies for the MDASI set of symptoms (Cronbach’s alpha
coefficient ¼ 0.82; 95% CI ¼ 0.78, 0.84) and for the set of interference items
(Cronbach’s alpha coefficient ¼ 0.857; 95% CI ¼ 0.484, 0.87). Factor analysis
resulted in a one-factor solution (general symptoms; eigenvalue ¼ 4.26) with a
psychological (distress and sadness) and a gastrointestinal subscale (nausea and
vomiting). Convergent and divergent analyses showed significant correlations
between symptom burden and distress and global health-related quality of life
(subscale of the European Organization for Research and Treatment of Cancer
Quality of Life Questionnaire-C30 Version 3.0.).
    Conclusion. The MDASI-German version is a valid tool for measuring patient-
reported symptom severity and symptom interference in German cancer patients.
It is easily applicable and can be used by German clinicians and researchers for

Address correspondence to: Heike Schmidt, MD, Medi-               Magdeburger Strasse 8, Halle 06097, Germany.
cal Faculty, Institute for Health and Nursing Sci-                E-mail: heike.schmidt@medizin.uni-halle.de
ence, Martin-Luther-University Halle-Wittenberg,                  Accepted for publication: April 29, 2014.

Ó 2014 U.S. Cancer Pain Relief Committee.                                                   0885-3924/$ - see front matter
Published by Elsevier Inc. All rights reserved.                      http://dx.doi.org/10.1016/j.jpainsymman.2014.04.007
2                                                Schmidt et al.                             Vol.   -   No.   - -   2014

screening and monitoring purposes and the comparison of international
data. J Pain Symptom Manage 2014;-:-e-. Ó 2014 U.S. Cancer Pain Relief
Committee. Published by Elsevier Inc. All rights reserved.

Key Words
Cancer, symptom burden, Validation, M. D. Anderson Symptom Inventory

Introduction                                                 lack of appetite loads on both the factors.1 A
                                                             component score of symptom severity can be
   Cancer patients often suffer from various dis-
                                                             calculated by taking the average of the 13 items
ease- or treatment-related symptoms that may
                                                             together.8 Symptom interference with daily
impair their functional status and result in
                                                             activities is measured by six functional scales
high symptom burden. Unrelieved symptoms
                                                             regarding general activity, mood, work, relations
can limit therapy options and reduce quality of
                                                             with others, walking, and enjoyment of life.
life.1 In clinical practice, symptoms might persist
                                                             Interference is also rated on a zero to 10 NRS,
unrecognized and undertreated because, when
                                                             zero being ‘‘did not interfere’’ and 10 being
not asked, patients might not report their symp-
                                                             ‘‘interfered completely.’’ The mean of the inter-
toms exhaustively. Furthermore, considerable
                                                             ference items can be used to represent overall
numbers of clinicians underestimate symptom
                                                             symptom distress. Symptom burden is defined
intensity.2,3 Therefore, to enable tailored sup-
                                                             as the sum of symptom severity and symptom
portive care measures, all relevant symptoms
                                                             interference.8
have to be assessed correctly and frequently
                                                                Because scores of single items can be
including the patients’ perceptions. Patient-
                                                             directly understood and implied in daily care
reported outcomes (PROs) are more and more
                                                             without further computing, the MDASI can
accepted as significant measures of symptom
                                                             be used easily to screen or to monitor symp-
intensity and interference as well as of health-
                                                             toms throughout the course of the treatment.
related quality of life.1,4e6 However, comprehen-
                                                             It has been translated and validated in many
sive standardized assessments are still not widely
                                                             languages including French, Taiwanese, and
used in daily clinical practice despite the many
                                                             Russian.9e16
available and valid questionnaires. To facilitate
                                                                The main objective of this study was to gather
implementation of PRO measures in everyday
                                                             representative information about symptom
practice, it is important not only to provide valid
                                                             severity, symptom interference, and symptom
but also feasible questionnaires that assess rele-
                                                             burden within a large heterogeneous popula-
vant symptoms.7
                                                             tion of cancer patients undergoing active anti-
   The M. D. Anderson Symptom Inventory
                                                             cancer treatment in different settings. To test
(MDASI) is a comparatively short self-
                                                             and provide a relatively short disease-specific in-
administered questionnaire that was developed
                                                             strument with a short recall period feasible for
and validated to measure symptom intensity
                                                             screening and monitoring for future use in clin-
and interference in cancer patients.1 It com-
                                                             ical routine, we decided to use the German
prises 19 numeric rating scales (NRSs) regarding
                                                             version of the MDASI (MDASI-G), which had
the presence and intensity of common symp-
                                                             already been linguistically validated, and to
toms and functional restrictions. The MDASI as-
                                                             perform a psychometric validation of this tool.
sesses the severity of 13 symptoms at their worst
in the last 24 hours on a zero to 10 NRS, with
zero being ‘‘not present’’ and 10 being ‘‘as bad
as you can imagine.’’1 The symptom scales repre-             Methods
sent two underlying structures, namely a general             Study Design
symptom severity factor (pain, fatigue, disturbed              The study was designed as a multicenter,
sleep, distress [emotional], shortness of breath,            cross-sectional, observational study to investi-
drowsiness, dry mouth, sadness, difficulty                   gate symptom severity and symptom interfer-
remembering, and numbness or tingling) and                   ence in a heterogeneous population of
a gastrointestinal factor (nausea and vomiting);             cancer patients in different settings. The
Vol.   -   No.   - -   2014             Validation of the MDASI-G                                        3

validation study was carried out alongside the           Statistical Analysis
large descriptive study. Recruitment took place             Scoring of the symptom severity and symp-
at the oncology departments of five German               tom interference scales including the handling
university hospitals and aimed to fulfill conve-         of missing values was carried out as described in
nience samples of 150 inpatients and outpa-              the MDASI User Guide.8 Descriptive statistics
tients per center.                                       were used to give an account of symptom preva-
                                                         lence, severity, and interference. In accordance
Participants                                             with the methodology used in the original En-
Inclusion Criteria. Patients aged between 18             glish language validation study and studies vali-
and 80 years, diagnosed with cancer, and un-             dating the MDASI for foreign languages, our
dergoing active anticancer treatment with an             validation analysis plan included examination
Eastern Cooperative Oncology Group Perfor-               of reliability, known-group validity, and analysis
mance Status (ECOG PS) of three or lower                 of convergence and divergence. To establish
who gave written informed consent were                   reliability, we examined the internal consistency
eligible to participate in the study.                    (Cronbach’s alpha coefficient). To establish
                                                         convergent validity, we performed a convergent
Exclusion Criterion. Patients lacking sufficient         and divergent analysis by testing the correlation
knowledge of the German language were not                of symptom burden (sum of the means of symp-
eligible.                                                tom severity and symptom interference) with
                                                         DT and global health-related quality of life
Data Sources                                             (EORTC QLQ-C30 global scale). To examine
   To perform the psychometric validation, we            the underlying constructs that the MDASI-G is
used the linguistically validated MDASI-G pro-           supposed to measure, we performed an explor-
vided by the M. D. Anderson Cancer Center. In            atory factor analysis on our validation sample.
addition, patients filled out the Distress Ther-         Because other language versions of the MDASI
mometer (DT), which is a short screening                 showed various factor solutions,1,9,12,13,15,16 we
tool for measuring self-reported distress on a           chose exploratory factor analysis over confirma-
zero to 10 NRS,17 and the two general ques-              tory factor analysis to better understand the
tions of the European Organization for                   constructs being assessed by the MDASI-G. All
Research and Treatment of Cancer Quality of              analyses were carried out using SPSS Version
Life Questionnaire-C30 (EORTC QLQ-C30),                  18 (SPSS, Inc., Chicago, IL).
Version 3.0, regarding global health-related
quality of life.18 Demographic and disease-
related data (age, gender, marital status, edu-
cation level, disease type, model of care, and
                                                         Results
type of treatment) also were collected.                  Participants
                                                            Of the 980 patients who were eligible, 697
Ethical Considerations                                   patients were included and agreed to partici-
   As study data were not available for the phy-         pate in the study (71%). Recruitment sites
sicians treating the participants, there was no          were internal medicine (n ¼ 268, 38.5%), gy-
direct advantage, for example application of             necology (n ¼ 146, 20.9%), surgery (n ¼ 104,
supportive measures, for the participants. To            14.9%), radiotherapy (n ¼ 93, 13.3%), urology
reduce the burden on the patients, we limited            (n ¼ 58, 8.3%), head and neck (n ¼ 19, 2.7%),
the number of items to be answered and did               and dermatology (n ¼ 7, 1.0%) wards. Recruit-
not use the problem checklist of the DT or               ment rates are shown in Table 1; demographic
another comparable reference questionnaire               and disease-related data are shown in Table 2.
assessing symptoms and functional impair-                As nonparticipants did not give permission to
ments. Patients who were not willing to partic-          collect any data, the reasons for nonparticipa-
ipate also did not give permission to save any           tion could not be examined.
data. Therefore, reasons for nonparticipation
could not be elicited. The study was approved            Descriptive Analyses of the MDASI-G
by the local ethics committees of the partici-             Descriptive analyses were performed
pating university hospitals.                             following the instructions given in the MDASI
4                                                                    Schmidt et al.                             Vol.   -   No.   - -   2014

                         Table 1                                                 between one and three, moderate if it was rated
                    Recruitment Rates                                            between four and six, and severe if it was rated
Center               Asked, n                  Recruited, n (%)                  equal or greater than seven on the zero to 10
1                       320                       150   (47.9)                   NRS. Descriptive results for means, symptom
2                       156                       150   (96.1)                   prevalence, and severity are presented in
3                       196                       158   (80.6)                   Table 3.
4                       143                        97   (67.8)
5                       165                       142   (86.1)
                                                                                 Statistical Analyses
                                                                                 Reliability. We examined internal consistency
user guide.8 Eleven patients did not complete                                    by calculating the Cronbach’s alpha coefficient.
the required seven items of symptom severity                                     Following the rule of thumb by George and Mal-
and two patients did not complete the                                            lery, alpha values greater than 0.9 are rated excel-
required four items of symptom interference.                                     lent, greater than 0.8 as good, greater than 0.7 as
  Following the National Comprehensive Can-                                      acceptable, and values lower than 0.6 as doubt-
cer Network guidelines for the assessment of                                     ful.20 Analysis showed good internal consis-
pain19 and the original validation study,1 we                                    tencies for the MDASI set of symptom items
defined symptom severity as mild if it was rated                                 (Cronbach’s alpha coefficient ¼ 0.82; 95%
                                                                                 CI ¼ 0.80, 0.84) and for the set of interference
                         Table 2                                                 items (Cronbach’s alpha coefficient ¼ 0.84;
         Participants’ Demographic and Clinical                                  95% CI ¼ 0.82, 0.86; Table 3).
                 Characteristics (N ¼ 697)
Characteristics                           n (%)          Missing                 Construct Validity. Construct validity was as-
Age (y), mean (SD)                         a
                                       60.6 (12.9)         109                   sessed by factor analysis regarding the symptom
Gender                                                                           scales. The data were suitable for factor analysis
  Female                                349 (50.1)
Marital status                            693                    4
                                                                                 (Kaiser-Meyer-Olkin criterion ¼ 0.80). The cor-
  Married, living with partner          469 (67.3)                               relation matrix with Z-standardized values
  Living alone                          223 (32.0)                               showed highest correlations between distress
Education level                           663                34
  Primary school                          9 (1.3)
                                                                                 and sadness (r ¼ 0.78; 95% CI ¼ 0.74, 0.82)
  Compulsory (9) y                      254 (36.4)                               and nausea and vomiting (r ¼ 0.67; 95%
  Middle school                         252 (36.2)                               CI ¼ 0.58, 0.74). Lowest correlations were
  High school                           148 (21.2)
ECOG PS                                   681                16
                                                                                 found between vomiting and difficulty remem-
  0 (Fully active)                       88 (12.6)                               bering (r ¼ 0.087; 95% CI ¼ 0.007, 0.18)
  1 (Restricted but ambulatory)         267 (38.3)                               and between poor appetite and numbness
  2 (Ambulatory, capable of             171 (24.5)
    self-care)
                                                                                 (r ¼ 0.07; 95% CI ¼ 0.02, 0.16).
  3 (Capable of only limited            155 (22.2)                                  The number of factors was identified using ei-
    self-care)                                                                   genvalues together with the scree plot and par-
Disease type                              670                27
  Gastrointestinal                      194 (27.8)
                                                                                 allel analysis. The scree plot shows the factors
  Breast                                 97 (13.9)                               against the respective eigenvalues (Fig. 1). Par-
  Genitourinary                          65 (9.3)                                allel analysis ‘‘involves extracting eigenvalues
  Pulmonary                              62 (8.9)
  Gynecological                          58 (8.3)
                                                                                 of random data sets that parallel the actual
  Head & Neck                            52 (7.5)                                data set with regard to the number of cases
  Brain                                   6 (0.9)                                and variables. Factors are retained as long as
  Other                                 136 (19.5)
Model of care                             693                    4
                                                                                 the ith eigenvalue from the actual data is greater
  Inpatient                             430 (61.7)                               than the ith eigenvalue of the random data
  Outpatient and day clinic             263 (37.7)                               set.’’21 Results of parallel analysis, eigenvalues,
Type of treatmentb
  Operation                             407 (58.4)
                                                                                 and the scree plot resulted in a possible three-
  Chemotherapy                          511 (73.3)                               factor solution. Principal axis factor analysis
  Radiotherapy                          195 (28.0)                               with varimax rotation was carried out for the
ECOG PS ¼ Eastern Cooperative Oncology Group Performance                         13 MDASI-G symptom items. The eigenvalues
Status.
However, no statistical difference between age groups at the re-
                                                                                 of the three factors were 4.26, 1.41, and 1.20,
cruiting centers was found, P ¼ 0.7.                                             respectively explaining 52.9% of the variance
a
  Mean age had to be computed for n ¼ 588 participants because
one center documented age groups (n ¼ 109).
                                                                                 (32.8%, 10.9%, and 9.2%, respectively). Factor
b
  Patients may have received one or more treatments.                             1 included affective symptoms with distress,
Vol.   -   No.   - -   2014                             Validation of the MDASI-G                                                      5

                                                         Table 3
                              Descriptive Results of MDASI-G Referring to the Last 24 Hours
MDASI-G Last 24 Hours
(N ¼ 697)                                 n          Mean (SD)            Milda (%)       Moderateb (%)       Severec (%)   Cronbach’s a

13 Symptom severity items                            2.2 (1.5)                d                  d                d            0.82d
                                                    Minimum 0,
                                                     Maximum 6.7
  Pain                                  679          2.5 (2.7)               29.8               20.4             10.2          0.81
  Fatigue                               679          3.3 (2.7)               33.7               28.7             14.3          0.79
  Nausea                                671          1.2 (2.3)               18.9                8.6              5.3          0.81
  Disturbed sleep                       681          2.9 (3.0)               28.8               21.1             14.5          0.81
  Distress                              676          3.1 (3.0)               26.1               24.5             16.1          0.81
  Shortness of breath                   677          2.0 (2.6)               26.5               14.9              9.2          0.82
  Difficulty remembering                677          1.2 (1.9)               26.7                8.5              3.0          0.82
  Poor appetite                         681          2.2 (2.9)               22.8               13.8             12.3          0.80
  Drowsiness                            681          1.7 (2.3)               29.0               14.9              5.5          0.80
  Dry mouth                             680          2.7 (2.9)               28.3               20.9             13.2          0.81
  Sadness                               668          2.7 (2.9)               26.8               20.8             12.5          0.80
  Vomiting                              683          0.6 (1.6)               10.0                3.0              2.7          0.81
  Numbness or tingling                  681          2.2 (2.7)               26.1               16.1             10.5          0.82
Six symptom interference items                       3.0 (2.3)                d                  d                d            0.84d
                                                    Minimum: 0,
                                                     Maximum: 10
    General activity                    659          3.8 (3.3)               29.3               21.1             22.4          0.82
    Mood                                670          2.9 (2.7)               33.6               24.7             11.2          0.83
    Work                                634          4.0 (3.6)               22.5               19.7             25.1          0.82
    Relations with others               668          1.5 (2.3)               24.8               10.6              5.5          0.86
    Walking                             671          3.3 (3.3)               24.1               18.5             21.5          0.83
    Enjoyment of life                   675          2.5 (2.8)               28.0               19.1             11.5          0.84
a
 $1e3.
b
 $4e7.
c
 >7e10, respectively, on a zero to 10 rating scale.
d
 Cronbach’s alpha coefficient for subscale. All other coefficients: Cronbach’s alpha if symptom is deleted.

sadness, and sleep disturbance. Factor 2                                         In addition, we performed a hierarchical clus-
included general symptoms with fatigue, drows-                                ter analysis to explore the symptom patterns.
iness, shortness of breath, dry mouth, difficulty                             Results are presented in the dendrogram
remembering, and numbness. Factor 3                                           (Fig. 2). The cluster analysis again reveals high
included gastrointestinal symptoms with                                       interdependencies between single symptoms,
nausea, vomiting, and lack of appetite. Pain                                  leading to sparsely selective clusters and low in-
loaded with 0.4 on the first factor, 0.31 on the                              tracluster distances22 In accordance with the
second, and 0.28 on the third factor.                                         factor analysis, the affective and the gastrointes-
   In analyzing the factor loadings, it must be                               tinal symptom domains are moderately promi-
noted that only distress and sadness and nausea                               nent. Thus, the results of the cluster analysis
and vomiting had factor loadings higher than                                  are partly consistent with the factor analysis.
0.8. Factor loadings are shown in Table 4. Reli-
ability analysis for the suggested factor solution                            Known-Group Validity. Known-group validity
showed a Cronbach’s alpha coefficient for the                                 (sensitivity) was examined by comparing the
first factor of 0.73 (95% CI ¼ 0.69, 0.76), for                               MDASI-G total scores between patients with
the second factor of 0.73 (95% CI ¼ 0.68,                                     low functional status (ECOG PS score $2)
0.75), and for the third factor of 0.69 (95%                                  and patients with high functional status
CI ¼ 0.65, 0.73). The first factor, however,                                  (ECOG PS score #1). As expected, the total
showed an increase of Cronbach’s alpha to                                     MDASI-G scores for symptom severity, symp-
0.88 if disturbed sleep was deleted and only                                  tom interference, and symptom burden were
distress and sadness were tested. For the third                               significantly higher for patients with a low
factor, Cronbach’s alpha increased to 0.78 if                                 functional status (Table 5).
poor appetite was deleted. Taking these results
into account, we decided on a one-factor solu-                                Convergent and Divergent Analysis. To examine
tion (general symptoms) with an affective and                                 convergent validity, we calculated the correla-
a gastrointestinal subscale.                                                  tions between symptom burden (mean ¼ 5.2,
6                                                                 Schmidt et al.                            Vol.   -   No.   - -   2014

                                                                Fig. 1. Screeplot.

SD ¼ 3.5), distress (mean ¼ 5.1, SD ¼ 2.7),                                   patients, consistent with the psychometrically
and global health-related quality of life                                     validated versions in other languages. The
(mean ¼ 49.4, SD ¼ 22.8). Pearson’s correla-                                  MDASI-G is applicable for patients with
tion coefficient (r) between symptom burden                                   different diagnoses and in different treatment
and global health-related quality of life was                                 settings. The very small number of ‘‘missings’’
r ¼ 0.66 (95% CI ¼ 0.70, 0.62) and be-                                      suggests a high degree of compliance and
tween symptom burden and distress r ¼ 0.60                                    good feasibility for everyday practice. Analysis
(95% CI ¼ 0.56, 0.65). Both were signifi-                                   showed good internal consistencies for the
cant two-sided correlations.                                                  MDASI set of symptom items and for the set
                                                                              of interference items. The calculated values
Discussion                                                                    for Cronbach’s alpha, with 0.82 for the MDASI
                                                                              set of symptom items and 0.84 for the set of
   The study demonstrates that the MDASI-G is
                                                                              interference items, are comparable with other
a valid and reliable tool for assessing symptom
                                                                              validation studies.1,9e16 For example, Cron-
intensity and interference in German cancer
                                                                              bach’s alpha for the symptom items was re-
                       Table 4                                                ported by Nejmi et al.10 as 0.78, by Ivanova
    Factor Loadings for Symptom Intensity Items                               et al.12 as 0.80 and by Yun et al.11 as 0.91.
                                        Factor Loadings                       Construct validity was assessed by factor anal-
                                                                              ysis. After careful consideration, we decided
Symptom Item                   Factor 1     Factor 2     Factor 3
                                                                              on a one-factor solution with gastrointestinal
Distress                         0.90         0.08          0.08              and affective subscales. This result is consistent
Sadness                          0.90         0.05          0.15
Disturbed sleep                  0.50         0.31          0.11
                                                                              with other validation studies identifying under-
Pain                             0.40         0.31          0.28              lying constructs of a gastrointestinal fac-
Shortness of breath              0.02         0.64          0.15              tor,1,9,14,16 an emotional and affective factor,
Fatigue                          0.33         0.59          0.35
Drowsiness                       0.21         0.59          0.29
                                                                              and a general severity component.9,12,15 As in
Difficulty remembering           0.20         0.59         0.03              other validation studies,1,9,12,14,15 the known-
Numbness                         0.01         0.57          0.01              group validity was satisfactory, showing signifi-
Dry mouth                        0.18         0.47          0.33
Vomiting                         0.05         0.02          0.86
                                                                              cant differences in symptom burden for
Nausea                           0.12         0.13          0.86              patients with ‘‘good’’ and ‘‘poor’’ ECOG PS.
Poor appetite                    0.22         0.30          0.59                 To limit the burden for patients, we did not
Method: Principal axis factor analysis with varimax rotation.                 apply a detailed reference questionnaire to
Vol.   -   No.   - -   2014                       Validation of the MDASI-G                                          7

           Fig. 2. Hierarchical Cluster Analysis. Dendrogram showing relative distances between item clusters.

establish concurrent validity but carried out a                      with moderate and severe intensity. If assessed
convergent and divergent analysis with global                        on a regular basis, these symptoms could be
scores for distress and global health-related                        taken care of early by psycho-oncologic coun-
quality of life. It would have been interesting,                     seling. The result that 20.4% of the patients re-
however, to compare the results of a question-                       ported moderate pain should likewise trigger
naire not using a zero to 10 scale, for example,                     efforts to optimize symptom management.
the EORTC QLQ-C30 with the MDASI, as was                             Furthermore, the assessment of symptoms in
done in other studies.9                                              connection with functional impairments is of
   The descriptive results show to what extent                       importance to anticipate possible supportive
patients are still suffering from symptom                            needs after discharge and the planning of
burden despite supportive therapy options.                           after-care.
Although, corresponding to other studies, the                           In summary, these findings emphasize the
observed low rates of vomiting indicate the suc-                     importance of integrating PRO measures in
cess of antiemetic treatment. Comparable with                        everyday clinical practice. However, ‘‘assess-
other studies,1,9,12,16 fatigue was among the                        ment is not enough’’ to optimize supportive
most prevalent and most severe symptoms, a                           therapy.23 It is of great importance that rele-
finding that might motivate clinicians to                            vant scores of symptoms, for example, mild
perform screening and offer guideline-based                          and severe are followed by special diagnosis
treatment. In addition, distress, sadness, and                       and treatment if necessary. Pathways of diag-
sleep disturbance were reported frequently                           nosis and treatment have to be established

                                                           Table 5
                                                     Known-Group Validity
                              ECOG PS       ECOG PS         ECOG           ECOG
                                0e1           2e4            0e1            2e4            Mean Difference
Parameters                       N             N           Mean (SD)      Mean (SD)          (95% CI)           P-value

Symptom severity                282            307          20.9 (16.7)    34.7 (18.6)   13.8 (16.7, 10.9)
8                                                Schmidt et al.                               Vol.   -   No.   - -   2014

and implemented. Health care professionals                   generously; the nursing departments of the
have to be trained in interpreting results and               five participating University hospitals who car-
acting accordingly. Our findings of symptom                  ried out the study; and Professor Tito Mendo-
severity and functional impairments despite                  za, Dipl. Psych., Dirk Rennert, and Dr. rer. Nat.
existing supportive options might be inter-                  Christine Lautenschl€ager for their fruitful
preted against the background that this pro-                 discussion.
cess in Germany is still evolving.
   The study had several limitations. The cross-
sectional design did not allow for examining                 References
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   Future research using longitudinal designs                oncology practice: secondary outcomes of a rando-
could examine sensitivity to change, provide                 mised controlled trial. Eur J Cancer 2010;46:
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Disclosures and Acknowledgments
                                                             10. Nejmi M, Wang XS, Mendoza TR, Gning I,
  This work was supported in part by ProKID
                                                             Cleeland CS. Validation and application of the
(German Cancer Information Service). The                     Arabic version of the M. D. Anderson symptom in-
authors H. S., C. S. C., A. B., M. L., and P. J.             ventory in Moroccan patients with cancer. J Pain
declare no conflicts of interest.                            Symptom Manage 2010;40:75e86.
  The authors thank the patients for partici-                11. Yun YH, Mendoza TR, Kang IO, et al. Validation
pating in the study and cooperating so                       study of the Korean version of the M. D. Anderson
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