Measuring the quality of life of cancer patients with
The Rotterdam Symptom Checklist ()
Northern Centre for Healthcare Research (NCH)
University of Groningen, The NetherlandsDepartment of Medical Psychology, Academic Medical Center Amsterdam; Department of Medical Decision Making,University Hospital, Leiden, The NetherlandsMedical Biometrics, University Hospital Freiburg, GermanyMedical Research Council, Cancer Trials Office, Cambridge, UKImperial Cancer Research Fund, Medical Oncology Unit, Western General Hospital, Edinburgh, UKChristie CRC Research Center, University of Manchester, Manchester, UKNorthern Centre for Healthcare Research, University of Groningen, The NetherlandsNoordelijk Centrum voor Gezondheidsvraagstukken Northern Centre for Healthcare Research Antonius Deusinglaan Groningen The Netherlands Telefoon/telephone: (+) - (+) - (R. Sanderman, Ph. D.) Fax: (+) - E-mail: R.Sanderman@med.rug.nl
C-G K B, D H
Haes JCJM de, Olschewski M, Fayers P, Visser MRM, Cull A, Hopwood P,Sanderman, R
Measuring the quality of life of cancer patients with the RotterdamSymptom Checklist: a manual/J.C.J.M. de Haes, M. Olschewski, P. Fayers,M.R.M. Visser, A. Cull, P. Hopwood, R. Sanderman. Groningen: Noordelijk Centrum voor Gezondheidsvraagstukken ()/Northern Centre for Healthcare Research ()( reeks meetinstrumenten; / series no. )Met lit.opg./with references ---Trefwoorden/keywords: meetinstrumenten; kwaliteit van leven; kankerpatiënten/questionnaires; quality of life; cancer patients
The large increase in the number of social science
existing instruments. The objective pursued by
studies addressing health-care related subjects has led
publishing the series is threefold. Firstly, the manuals
to the development of numerous instruments for
provide information, e.g. instructions on how the
measuring concepts like health, social support, func-
questionnaires should be scored, and descriptions of
tional status, and quality of life. However, the wide
the basic psychometric properties of the instru-
range of instruments that has become available,
ments. Secondly, the series aims to stimulate utiliza-
presents researchers with several problems. In the
tion of particular instruments, preferably identical
first place, the lack of information on the psycho-
versions of them, thus facilitating comparison of the
metric properties of some instruments makes it
results of different studies. Thirdly, the series will
difficult to assess the quality of a questionnaire.
enable researchers who wish to use a different instru-
Furthermore, it is not always clear to what extent a
ment, or who decide to develop a new one, to make
(theoretical) domain is covered by the existing in-
struments. Uncertainty about the comparability ofquestionnaires hampers comparison of results across
As the instruments included in the series are being
studies. The task researchers face whenever they
used in new studies, additional information will
have to select an appropriate measuring instrument
continuously be generated, e.g. concerning validity
and reliability, or the development of standard
Additional confusion is created by the many differ-
scores. Furthermore, an instrument may need to be
ent versions that exist of some questionnaires. It may
adapted to new insights. The users of the series will
prove hard to ascertain which version is the original
be kept informed of any new developments pertain-
one, and which versions are adaptations, made in-
ing to the instruments. Whenever important supple-
tentionally or not, of the original questionnaire.
mentary information emerges, a revised edition willbe published.
Researchers of the Northern Centre for Healthcare
Finally, users should take notice of the following.
Research () frequently encounter the above
Several rules, which may vary from instrument to
problems at the start of a new study. In order to help
instrument, should be observed when using the
them resolve these problems the has decided to
instruments presented in the series. We request you
publish a series of manuals on the measuring instru-
to carefully read the ‘Permission for use of the ’
ments used in research. Some of the instru-
ments have been developed by the , others are
Rotterdam Symptom Checklist, the history and development
Description of the and instructions
Guidelines for use of the
Use for case detection Number of measurements and measurement moments
The original Dutch validation studies The study The Fatigue studyThe study
Structure of the symptom distress scale
Original Dutch validation studies The study The Fatigue study
Permission for use of the Appendix A (Available languages)
Appendix B (Dutch version of ) Appendix C (English version of )
I would like to thank, in the first place, Jean Pruyn
and Ferd van Knippenberg. Without their originalwork and our stimulating debates, the RSCL wouldnot have been developed and used over such a longperiod. Secondly, I would like to acknowledge JanNeyt. As he initiated the first quality of life study inthe Netherlands, the instrument was developedthanks to him. Finally, I am grateful for AnitaLegtenberg’s preparation of this manual.
1 Department of Medical Psychology, Academic Medical Center,
Over the past decades the importance of investigat-
ing the quality of life of cancer patients has been
stressed increasingly. Quality of life is regarded as asubjective report of the patients’ experience of dis-
One instrument to measure the quality of life of
ease and treatment. Assessing quality of life is meant
cancer patients is the Rotterdam Symptom Checklist
(). The was originally developed as a tool
) enhance the insight into the consequences of the
to measure the symptoms reported by cancer patients
participating in clinical research. It soon proved
) indicate groups of patients at risk for developing
applicable to monitor the levels of the patients’
anxiety and depression and the presence of psycho-
) enable the comparison of the effectiveness of
logical illness (Trew & Maguire, ).
different treatment modalities or care programs,
The was constructed on the basis of secondary
and thus support decision making in clinical
analyses of the data from three studies done with
different checklists (Pruyn et al., ): ) the
An instrument to assess quality of life must in the
Hopkins Symptom Checklist, which was used in a
first place cover the relevant content: the concept to
population of psychiatric patients, patients
be measured. Quality of life is generally considered
with rheumatoid arthritis, and ‘normal’ controls
to be a multidimensional concept. In their review of
(Luteijn et al., ), ) a symptom checklist used in
instruments, Moinpour and colleagues (Moinpour
a study on the symptoms of breast cancer patients
et al., ) have suggested that the inclusion of a
(Linssen et al., ), and ) a Dutch version of the
physical and a psychological domain is to be consid-
Symptom Distress Scale developed by McCorkle
ered a minimal requirement for quality of life assess-
and Young (McCorkle & Young, ) applied to a
ment in cancer patients. Cella and Tulsky ()
group of hospitalized cancer patients (Leendertse
have advocated a three dimensional approach, in
et al., ). The selection of items from these
line with the WHO definition of health. In such an
checklists was based on factor loadings, relevance
approach a physical dimension, covering the func-
according to a group of experts in oncology, and the
tional status and physical symptom experience, an
distribution of answers. This process resulted in an
emotional dimension and a social dimension are
item list comprising physical and psychological
distinguished. De Haes and others (De Haes et al.,
symptoms. Patients were asked to indicate the degree
) have advocated the addition of an overall
to which they had been bothered by the indicated
measure to assess quality of life as well. Such global
symptoms over the past three days, on four-point,
valuation has been described as encompassing the
Likert-type rating scales. Items referring to the
evaluations of specific dimensions or attributes in an
activities of daily living were added to cover the
patients’ functional status. One item regarding the
In the context of clinical trials repeated measure-
overall evaluation of life quality was added later. On
ment requires assessment forms which are easy to
the basis of the early validation studies four items
handle for clinicians, nurses and datamanagers.
were deleted (De Haes et al., ).
Moreover, compliance of patients, especially whenill, will be enhanced if an instrument is easy to com-
An instrument should have adequate psychometric
properties. This means it should be reliable as well asvalid. As part of the validity of quality of life instru-ments the sensitivity to changes occurring as a resultof clinical events, i.e. clinical validity, needs to beestablished (Hays et al., ).
The was validated originally in a Dutch study
(De Haes et al., ) and since then has been usedin a number of Dutch and British investigations(Hopwood, ; De Haes & Welvaart, ;Fallowfield et al., ; Morris & Royle, ). These also provided evidence for its ease of applica-tion. Further validation studies have substantiated thereliability and validity of the in the Nether-lands, Italy, the United Kingdom and Portugal (DeHaes et al., ; Paci et al., ; Watson et al.,; Dos Santos et al., ). On the basis of itsfeasibility and validity the use of the was advo-cated in clinical research (Maguire & Selby, ) aswell as cost-effectiveness studies (Uyl-de Groot etal., ).
As a result of early dissemination of the and thedecision not to impose copyright on its use, differentversions of the instrument have been used in differ-ent studies and countries. This process has some-times led to confusion about the version to be takenas a starting point as well as about scoring rules. Therefore, we have decided to publish a manual toserve as a basis for dissemination, adaptations andscoring. In the present manual the use of the isdescribed and scoring rules are given. Also, an over-view of what is known regarding the psychometricqualities of the instrument is presented. Finally, toenable comparison, ‘norms’ are given for differentdisease-, treatment- and culture-related conditions.
been decided that concentration included earlier isno longer part of the psychological distress subscale.
The ‘concentration’ item has been excluded from
The is a self-report measure to assess the qual-
the psychological distress subscale as it proved less
ity of life of cancer patients. The was designed
clearly related to psychological distress. It turns out
to cover, originally, domains: physical symptom
to be linked to physical distress, notably fatigue (see
distress, psychological distress, activity level and
Table ). With concentration omitted from the
overall global life quality. These form the main
psychological distress scale, none of the psychologi-
scales. The items regarding psychological distress
cal symptoms then has an explicit physical compo-
have been interspersed among the items regarding
nent (Plumb & Holland, ). Moreover, in Brit-
physical distress in order to avoid response sets in
ish studies the version without the item concentra-
the first place. Also, the possibility of inducing dis-
tion turned out to indicate clearly the absence or
tress by putting together all psychological symptoms
presence of psychological morbidity 1.
has served as an argument. On the basis of factoranalyses presented in the current manual and earlier,
The activity level scale consists of items regarding
more specific subscales within the physical symptom
functional status. These items form a scale in which
distress experience can be constructed in some stud-
mobility as well as social and role activities are cov-
ies (De Haes et al., ; De Haes et al., in prepara-
ered. The scale is not related to cancer specifically.
tion). An overview of subject headings and number
In some populations, like the elderly, the last item:
of items in the main scales is given in Table . More
‘go to work’ may not be relevant for any respondent.
specific subscales are referred to later (see chapter
If so this item may have to be omitted from the
questionnaire. Also it must be noted that in somepopulations, especially in breast and gynaecological
The items constituting the main scales in the
cancers the item is not applicable for many women.
Two solutions are available: either substitution (seepar. .) or transformation over seven items.
The physical symptom distress scale consists of items referring to different physical symptoms.
The overall valuation of life (sometimes called either
Some symptoms such as headaches or fatigue, may
global quality of life or overall quality of life) is
be experienced by people in general as well as by
measured by one single item included in the check-
cancer patients. Other symptoms are more specifi-
list. The item is derived from research in the quality
cally to related to cancer or cancer treatment: e.g
of life of the population in general. An affective
gastro-intestinal and chemotherapy related symp-
operationalisation was chosen for this item as such
toms. The items constituting the physical symptom
approach proved, in line with theory, more sensitive
to clinical change (De Haes et al., ).
The psychological distress scale consists of items
regarding different symptoms that may be experi-
For most items responses are given on -point Likert-
enced by cancer patients as well as in other popula-
type scales. For the patients’ symptom experience of
tions. None of these items refers to psychological
both physical and psychological distress responses
symptoms that might be considered ‘psychosomatic’
range from ‘not at all’ to ‘very much’. For the activ-
(e.g. headaches or sleeping problems). The item
ity level scale responses range from being ‘unable’ to
loneliness or feeling lonely was omitted earlier on
perform an activity up to being able to do so ‘with-
the basis of skewed distribution. Moreover, it has
out help’. An example is given to instruct the respond-
Content of items of four main scales in RSCL
ent about answering the question (please note that ‘a
little’ is circled in the instruction, see Appendix).
Originally, the was chosen to cover ‘the past
The overall valuation of life is assessed on a seven
three days’. This time frame has been changed to
point Likert-type scale, as is usual in the literature
‘during the past week’. The decision to opt for
regarding the population at large from which the
somewhat longer period was based on the wish to
question was derived. Answers range from ‘excellent’
cover more fully the presence of side effects while
remaining within the time span easily rememberedby the patient. Moreover, although longer periods of
time have been found to result in a stronger relation
In quality of life questionnaires the experience of
between symptom reporting and ‘complaining ten-
symptoms or complaints can be formulated either in
dency’ or neuroticism, this tendency to report or
a (dys)function mode (e.g. is the patient consti-
experience physical distress on the basis of personal-
pated?) or from the experienced burden perspective
ity characteristics rather than on the basis of external
(e.g. to what extent is the patient bothered by con-
influences is still less evident when asking questions
stipation). In the the level of symptom experi-
over a week (Linssen et al., ).
ence is formulated in an experienced distress mode. The respondent is asked to what extent they arebothered by the symptom mentioned (see note ). In the activity level scale a functional approach isfollowed. Respondents are asked to what extent theyare able to perform activities.
Summation of item scores to compute scales
(s1+s3+s5+s7+s8+s10+s12+s13+s14+s15+s16+s18+s20+s21+s22+sum of psychological symptom scoresact1+act2+act3+act4+act5+act6+act7+act8When reversing the activity level and overall valuation of life scale for reasons of consistency the scoring will be32-(act1+act2+act3+act4+act5+act6+act7+act8) and 1-all1 respectively.
For example: suppose someone has a raw score of
on the psychological distress scale. Since the scale
score is calculated by summing items, the range is
The scoring of items is straight forward: ranking
to . This would imply that the transformed
from the left (first to the right) th column. Thus
score of this person is [( - )/]* = .
scores given in the Symptom Checklist are
After transformation of scores the level of impair-
(not at all), (a little), (quite a bit), (very much).
ment in one domain compared to that in another
In other words: the higher the score, the higher is
the level of burden or impairment 2. The activity level items are, likewise, scored from
to . The level of dysfunction in these items is, as a
As scales are constructed in such a way, that items
result, negatively related to the score height: the
belonging to a scale have high intercorrelation, it is
higher the score, the better the function. The same is
possible to substitute values for missing data. An
true for the quality of life item scores range from
accepted way of handling missing values in the
(excellent) at the top to (very poor) at the bottom.
different (sub)scales of the is the insertion of
Scores for the activity level scale and the overall
the personal scale mean of the respondent on a
valuation can be reversed in order to achieve ratings
missing value. This procedure can be followed when
for the different indicators which are all in the same
the respondent has filled in at least % of the items
direction. Obviously, this should be mentioned.
of the (sub)scale in question. In other words, if the
Scale scores are obtained by summating scores of
scale has an uneven number of items, half the
individual items. The computation is given in
number of items plus one should have been filled in.
If fewer items have been completed by the respond-ent, s/he is considered a missing case for that par-
It is possible to standardize the scores of scales by
Alternative options have been suggested recently by
transforming raw scores into scores on a -point
Zwinderman (Zwinderman, ) and Hopwood
scale in a systematic way. This makes results more
and colleagues (Hopwood et al., ).
easily interpretable. Moreover, the level of quality of
The handling of missing data is still being discussed
life impairment in the different scales can be com-
in the literature. Therefore, it is important that
pared more easily. In such a scale implies a level of
investigators state clearly what they have done when
no impairment, implies the highest level of
impairment. The way to transform scores is given inthe following formula:
No cut off scores for physical distress levels or indi-
When the is used for descriptive purposes, the
vidual physical symptoms are available yet.
clinically most relevant information is derived fromthe percentage of patients who reported being both-
ered by the symptom to any degree: in other wordsto dichotomize the results reporting the percent of
patients reporting no problems (‘not at all’) and the
The use of the has proved appropriate in can-
percent of patients reporting having been bothered
cer patients undergoing treatment by different
by the symptom (taken ‘a little’, ‘quite a bit’ and
modalities: patients undergoing surgery, chemo-
‘very much’ together). Thus an overview of patients
therapy as well as radiotherapy. The has also
being burdened by each symptom is given.
been used among patients with disease at different
The second option is the integral reporting of levels
sites: breast, prostate, ovarian, lung, colo-rectal,
of distress. If this is needed, the percentage of pa-
gastric, bladder, renal, head and neck, and testicular
tients reporting the four levels of symptom distress
cancer as well as heterogeneous groups of cancer
patients. The instrument has been used in early as
Reporting of mean levels of distress regarding spe-
well as advanced disease. Finally, in a number of
cific symptoms and whole scale can only be useful
studies the has been used in non-cancer or
from a clinical point of view if norms are available
‘normal’ populations as comparison groups.
and, thus, comparisons can be drawn.
It is important to note that no symptoms from the
For treatment comparison different results are rel-
original questionnaire should be left out when using
evant. Group means and standard deviations can be
the . One exception is the item ‘go to work’
computed for scale scores and also for individual
symptoms. However, most of the scales do not
In some studies specific disease- or treatment-related
follow a normal distribution and tests based upon
symptoms are relevant to the particular population
medians or non-parametric tests may sometimes be
under study. For example, in patients with distant
more appropriate. On the basis of these, multivariate
metastases one might want to study bone pain. Also,
testing of group differences and changes over time
in studies where specific treatment side effects are
relevant, e.g. hot flushes in hormonal therapy, thesemay have to be covered. Additional items can be
added in the same format as the symptom
The has been proved useful in the detection of
distress scale. The selection of extra items should be
cases and non-cases when establishing psychological
based on the opinion of experts and patients origi-
or psychiatric morbidity. In those cases a cut off
nating from a population similar to the one to be
score for the psychological distress scale must be
studied. It is advised that a minimum of three pa-
chosen to indicate the presence or absence of ‘dis-
tients and/or experts, mostly clinicians, is ap-
ease’. Different papers may report different cut off
proached. Items should be added at the end of the
scores based on the sample size and disease status as
and not interspersed in the existing scale.
well as the psychiatric diagnostic criteria used. Mostrecently a cut off point of was shown to be best in
disease-free and stable patients whereas in patients
The may be administered as a self-report ques-
with progressive disease the cut off point yielding
tionnaire or by interview. It is readily administered
good sensitivity and specificity was 4, 5 (Ibbotson
in a clinical setting e.g. in a waiting room, as it has
proved easily understandable it also lends itself to a
Patients take, on average, minutes to complete the
Telephone interviewing is possible. However, in
such situation it is advisable to send a questionnaireto the respondent before the actual interview is
done. The respondent then can follow the questions
The has proved useful in the detection of psy-
posed over the telephone more easily and can read
chological or psychiatric morbidity (Hopwood et al.,
the questions whilst replying. The same is possible
; Ibbotson et al., ). This enables the early
in oral interviewing. If the respondent is given a
selection of patients being at risk for distress over the
copy of the questionnaire s/he can read along while
course of the disease. It may also enable the selection
the interviewer is posing questions.
of patients who are likely to benefit from psycho-logical or psychiatric intervention. If the is used
as a first screening instrument, a more extensive
The is a self-report questionnaire.
psychiatric diagnostic interview may than be carried
Preferably, the first completion of the questionnaire
out to investigate further morbidity (Hopwood et
is assisted so as to ensure that the patient understands
al., ; Ibbotson et al., ).
the questions. This might be done by a researchnurse or a datamanager. If so, it is still essential that
Number of measurements and measurement moments
the patient fills in the questionnaire him/herself
If quality of life is assessed in the context of a clinical
study, the minimal requirement is to assess it twice
Sometimes patients ask for advice, for example from
during treatment. Thus it will be possible to discern
partners, when answering the questions posed. This
must be avoided as far as possible. It is advisable to
The specific timing of assessment points depends on
make clear instructions in the introduction of the
when toxicity is expected. One wishes generally to
study to prevent this from happening.
sample occasions when the treatment burden is
Some patients are unable to complete the question-
expected to be the greatest and the times at which
naire. This may be the result of ‘forgetting specta-
toxicity is at a minimum. If long term effects are
cles’, inability to read, cognitive impairment or a
essential in the evaluation of treatment these should
severe disease state. Where the patients can not read,
the questions have to be read by another person and
In an optimal approach it is important to assess
the patient may still give the answer. In those cases
quality of life before the start of treatment, prefer-
where the patient is unable to answer questions
ably before the randomization result is known. At
anyway, the questions may be posed to others,
this point patients will not have been informed as to
‘proxy’s’. It is important to note that the answers of
which treatment will be allocated to them. Baseline
these proxy’s are bound to be different from the
measurement can help in comparing treatment arms
ones patients would have given (Sprangers &
and thus reveal possible differences at the start of
Aaronson, ). Therefore in those cases where it
treatment. Controlling for background quality of life
can be anticipated that the patient will become
in the analysis as well as computing change from
unable to complete the questionnaire as the disease
baseline becomes possible on the basis of the initial
advances, it is advisable from the outset to ask the
proxy as well as the patient each to complete inde-
If the is used in the context of an explanatory
pendent assessments thus the original discrepancy
study in which quality of life is compared or corre-
may serve as a starting point for understanding bias
lated with other (psychosocial) variables, it can be
If the is used for the detection of clinical cases,
1 The earlier British studies referred to were done with a slightly different
it may be used once at the beginning of treatment to
version of the : 1) the questions referred to: “to what extent did you
test patients for being at risk for developing psycho-
have” instead of “to what extent were you bothered by”. 2) In these studies
logical morbidity. Evidently, it could also be used at
the version referring to a 3-day period was still used. 3) The item loneliness
other times during the course of disease and treat-
ment, if considered especially relevant.
2 Some reseachers have used an alternative approach: assigning scores from
0 (not at all) to 3 (very much). Such approach implies that any deviation
from 0 implies quality of life impairment. For reasons of comparability such
approach should be mentioned when presenting results.
3 Some caution is needed here. When items are related more closely, i.e. the
scale is more homogeneous, a higher score in one item goes along more
evidently with a higher score in another item. As a result, as some scales are
more homogeneous than others high levels of impairment can be reached
more easily when transformation scores are used. This may make scales less
comparable than they seem to be after transformation.
4 Evidently, authors using a scoring system of 0-3 for the individual items
5 The cut off point here would be 9 for a scoring system counting from 0-3.
ease-free ‘patients’ (n=), and % of the normal
controls (n=). The patients under treatment had
For a quality of life instrument to be useful in any
a mean age of , the disease free patients of , the
kind of research its psychometric properties should
comparison group of . Of the under treatment
be substantiated. Several studies have been carried
sample .% was male, .% was female; of the
out to establish the psychometric qualities of the
disease free patients .% was male; .% was
. In the overview given below, first the structure
female, of the comparison population .% was
of the symptom distress list is described as to support
the construction of scales and subscales, secondly thereliability of the (sub)scales is described, thirdly the
validity of the instrument is discussed.
In this trial pre-/peri-menopausal patients, aged less
Over the last years the has been used in numer-
than years, with histologically confirmed stage II
ous studies in oncology. It would be impractical to
node positive breast cancer were recruited. The
report on the data from all these here. We have
patients originate from different countries and
therefore made a selection of three. The data from
speaking seven different languages. Of the eligi-
these studies will be supplemented with data reported
ble patients, (%) completed the first quality of
life questionnaire, at baseline. Currently, these patients were potentially available for the second
The original Dutch validation studies
measurement. (%) questionnaires were avail-
The was validated initially in three study sam-
able for analysis. patients completed both the
ples. The first consisted of a group of female patients
visiting an outpatient clinic for either follow up or
For the cross cultural comparison clusters of lan-
chemotherapy administration. The patients (n=,
guage/culture background have been formed. The
response rate %) were asked to fill in the ques-
sample was divided in six subsamples with a mini-
tionnaire whilst waiting in the hospital, and later
mum number of respondents of on the basis of
the countries involved: ) an Eastern European sam-
The second sample consisted of a group of pa-
ple involving Hungary, Czechia and Slovakia
tients participating in a randomized trial comparing
(n=), ) an English speaking cluster involving
two chemotherapy regimens (Hexacaf and -)
Australia, Ireland and the United Kingdom (n=),
for the treatment of advanced ovarian cancer. These
) the Finnish sample (n=), ) the French cluster
patients completed the questionnaire in the clinic
involving France and Belgium (n=), ) the Ger-
several times in the course of the trial (mean number
man sample (n=), and ) a ‘Latin’ cluster involv-
completed: . and ., respectively).
ing Argentina, Portugal and Spain (n=).
In the third study a heterogeneous group of cancer
Multivariate analyses of variance with the quality of
patients who had either been operated in the past
life scales as dependent variables, were performed to
three months or were receiving chemotherapy, and a
establish whether indeed the cluster of countries
group of cancer patients who had been without
were similar. Significant differences were found
symptoms of the disease for three years or more,
within the Latin cluster only. Patients from Spain
were compared with a random sample of the Dutch
differed with respect to quality of life from the ones
population. Patients and controls were sent a letter
from Argentina and Portugal but only at baseline.
inviting them to participate, a copy of the question-
The results regarding this cluster have, therefore, to
naire, and a return envelope. The questionnaire was
be considered with caution. Because the on-treat-
completed and returned by % of the patients
ment measurement is especially relevant in the con-
currently under treatment (n=), % of the dis-
text of this manual, the data from the second meas-urement point are reported here.
In the Fatigue study two patient samples were ap-
In the earlier report on the structure of the
proached. The Dutch sample involved patients in
three different factor analyses were reported (De
their last week of radiation treatment (n=).
Haes et al., ). In the first sample, the first factor
Patients were given a letter inviting them to partici-
(explaining .% of the variance) referred to the
pate, a copy of the questionnaire and a return enve-
experience of psychological distress. The highest
lope. They were asked to fill in the questionnaire
loading on the second factor (explaining .% of the
within the next three days. The questionnaire was
variance) had sore muscles and pain in the back.
returned by (%) of these patients.
These symptoms, as well as headaches, referred to
The Scottish sample involved radiotherapy pa-
the experience of pain. A number of symptoms was
tients. They were invited to fill in the questionnaire
correlated with this factor less directly related to the
either in the waiting room in the hospital, or at
experience of pain. The third factor (explaining
home within hours. patients (%) returned
.% of the variance) referred to the experience of
gastro-intestinal complaints: vomiting, nausea and
The Dutch sample filled in the Multidimensional
lack of appetite loaded highly on this factor. On the
Fatigue Inventory () along with the . The
fourth factor (explaining .% of the variance) fatigue
Scottish patients completed the , the and
and lack of energy were important items. The pattern
the Hospital Anxiety and Depression scale ().
emerging from this analysis is a structure of fourfactors, more or less unambiguously concerned with
relevant elements in the experience of the disease
In the project a cancer patient sample as well
and treatment. The content of the first factor, psy-
as a control group were addressed: newly diag-
chological distress, is the clearest, that of the other
nosed cancer patients (gynaecological, colorectal,
factors, i.e. pain, gastro-intestinal complaints, and
lung and breast cancer) and ‘controls’ from the
general population matched for age, sex and region
In the principal component analysis in the third
of origin. Patients were interviewed by trained inter-
study two factors had an Eigenvalue of . or higher.
viewers, but the was filled out as a self-report
These explained .% of the variance. The first
measure. All subjects came from the North of the
factor (explaining .% of the variance) referred
evidently to the experience of psychological distress.
Patients were interviewed three, nine and months
All items that at face value would be considered
after diagnosis. Data from the first and third wave
psychological were strongly related to this factor. The
second factor (explaining .% of the variance) con-cerns almost all of the physical symptoms in the
checklist. A number of symptoms were weakly related
to this factor (sore muscles, low back pain, abdomi-nal aches).
When constructing the , the symptoms selectedto be inserted in the symptom distress scale were
gathered, as outlined in the Introduction, on the
In the baseline measurement of the Zebra study, the
basis of secondary analyses of results from earlier
two factor structure of symptom checklist gave the
studies and of interviews regarding relevance of the
best interpretable solution. In this factor analysis the
items. Subsequent studies have investigated whether
symptoms that were originally part of the first factor
the symptoms selected could be organised into dif-
were so again: anxiety, tension, nervousness, worry-
ferent scales reflecting more specific quality of life
ing, depression, despairing about the future, irritabil-
domains. These results will now be reported.
ity and concentration problems. Three other symp-
toms loaded also, although less strongly, on this first
factor structure was not replicated. As a consequence
factor. All other physical symptoms had higher factor
it was decided to do a factor analysis in which the
loadings on the second factor. The earlier two factor
number of factors was set free. On the basis of the
solution was thus, largely, replicated.
plot of eigenvalues a three and a five factor solution
For the second measurement, where patients com-
were inspected. The five factor solution gave the best
pleted the questionnaire during chemotherapy, the
interpretable results. These are given in Table .
Factor loadings on 5-factor (complete case analysis) solution during treatment
only factor loadings of .25 or higher are reported.
As can be seen from this Table, the first factor refers
to the experience of psychological distress. Of the
The first factor systematically refers to the psycho-
original scale all psychological distress symptoms
logical distress experience. A two factor model yields
were included. Also was decreased sexual interest.
a physical and psychological scale. We therefore
Concentration problems loaded on the second factor
depart in general from the two factor model.
along with tiredness, lack of energy, difficulty sleep-
More specifically, factors referring to fatigue and
ing, shortness of breath and dry mouth. Apart from
gastro-intestinal symptoms are evident in several
the latter, these symptoms are clearly related to the
samples. In the studies reported by Watson and
fatigue experience. The third factor was constituted
others (Watson et al., ) and Paci (Paci, ) in
by the following symptoms: lack of appetite, nausea,
the and Italy a gastro-intestinal factor also became
vomiting, dizziness and diarrhoea. Except for dizzi-
evident. It is clear that results are dependent on the
ness these factors refer to gastro-intestinal dysfunc-
sample under study and the moment of measure-
tion. The fourth factor is mainly referring to the
ment. In specific studies, factor analyses may yield
experience of pain in different parts of the body:
relevant subscales. On the basis of reliability testing
sore muscles, low back pain, abdominal aches, con-
these can be used further within those studies.
stipation and shivering. Finally, the fifth factorseenXd‘o include the symptoms most specificallyrelated to chemotherapy: heartburn, tingling, sore
mouth and loss of hair. Headaches are equally relatedto fatigue and the pain experience.
Reliability refers to the amount of random error thatis involved in the measurement of a given character-
istic. One way of establishing reliability is the assess-
The data from the Fatigue study were analyzed for
ment of the characteristic a second time as to inves-
both samples separately. A non forced factor solution
tigate the repeatability of the score obtained. How-
yielded, on the basis of the criterion that Eigenvalues
ever, this approach assumes that the characteristic
exceed factors in both samples. These explained
measured remains stable between measurements.
% in the Scottish and % in the Dutch sample.
This, as will be outlined, is not necessarily true for
In both samples, again, the first factor clearly re-
the quality of life of cancer patients.
ferred to the experience of psychological distress.
Another approach, as followed here, is establishing
Seven items are included. The first factor explains
the internal consistency (Cronbach’s alpha) of a
% in the Scottish and % in the Dutch sample.
scale. Internal consistency is considered the basic
The second factor in the Scottish data refers to fatigue
requirement for reliability by Nunnally (Nunnally,
(explaining % of the variance), the third to gastro-
). Internal consistency refers to the fact that
intestinal symptoms (explaining % of the variance).
different items in a scale cover the same domain of
The other factors are less clearly interpretable. In the
content. It implies that what is being measured is
Dutch data the second factor refers to gastro-intesti-
not a random sample of items, but relates to one
nal symptoms (explaining % of the variance) and
domain consistently. For group comparison an
the third to fatigue (explaining .% of the variance).
internal consistency of . is considered satisfactory,
The seventh factor (explaining % of the variance)
for screening purposes, i.e. the detection of cases, it
refers to pain related symptoms. Other factors are
must be . (Nunnally, ).
less easily interpretable again except for the onecontaining diarrhoea and constipation (explaining% of the variance).
Reliability of RSCL scales in three studies 1Internal consistency unless stated otherwiseNo symptom subscales were identified at this stageMokken analysis for hierarchical data
As can be seen from Table the reliability of the
Reliability is consistently good for the psychological
physical symptom distress subscale is good consist-
distress subscale also. In many of the samples studied
ently over the samples involved. Based on the results
the reliability is good enough to warrant the use of
of the factor analysis in the second sample of the
the instrument for screening purposes.
original validation study and the results from the
The scale regarding the activity level has a varying
Zebra study specific physical distress subscales were
internal consistency. Inspection of the data of the
defined. These pertain to fatigue, pain related symp-
Zebra study reveals that this is weak when the
toms, gastro-intestinal symptoms and chemotherapy
amount of variance on some items is low in a sam-
related symptoms. In the first study the pain, fatigue
ple. No patients in these samples experience impair-
and gastro-intestinal symptom subscale have ad-
ment in the lower levels of activity dysfunction, such
equate reliabilities (., . and . respectively). In
as self care. Where variance is sufficient, the reliabil-
the Zebra study the reliabilities of these subscales is
ity of the activity subscale is satisfactory to good.
less good (.; . and . respectively) 7.
As in fact the activity level scale is built in a hierar-
chical way we finally computed the reliability using
the Mokken model in the Fatigue study. This model
Whether an instrument is measuring what it is sup-
is used to establish whether a hierarchical approach
posed to measure can be established in different
would fit the data. The analysis is used to establish
ways. To established construct validity hypotheses
whether indeed the items can be seen as a scale
formulated on theoretical grounds are tested. The
where the level of function in one item predicts the
scores obtained with the instrument have to behave
level of function in another although the latter may
in a predicted manner to support its validity. In this
be systematically higher or lower. Violations of the
paragraph predictions are based on the fact that the
assumption of hierarchy are given in the analysis.
scale is supposed to be related with criteria )
For the Dutch as well as the Scottish data the hierar-
measuring the same construct, ) measuring a re-
chical structure of the activity level scale was con-
lated construct or ) measuring an attribute that is
firmed. No major violations were found. The reli-
ability of the scale was good for both samples 8. The hierarchical order of the activity scale items was
Physical symptom distress was related to the Medi-
cal Outcome Study instrument (-) that meas-
ures the patient health state generically (Stewart et
al., ) 10. The results are given in Table . Physical
symptom distress turned to correlate strongly to
physical and role function and health perception (all
r’s >.). It is related less strongly to mental health.
It is unrelated to a one item pain scale.
heavy housework/household jobs go to work
As on the scale level on the individual item levelrelations can be studied. In the Fatigue study scores
on the tiredness item discriminated significantly
It can be concluded that the reliability of the physi-
between patients scoring high and low on the Multi-
cal distress scale is good. The reliability of the psy-
dimensional Fatigue Inventory ().
chological distress scale is good and excellent in anumber of samples. The use of that scale as a screen-
The psychological distress scale has been related to
ing instrument is therefore acceptable. The activity
several other instruments assessing psychological
level scale has a good reliability in most studies: the
distress or morbidity. Watson and others (Watson et
internal consistency as well as the hierarchical struc-
al., ) found the psychological distress scale to be
ture was proven good to excellent. In some samples,
highly related with anxiety (r=.) as well as depres-
as a result of a lack of variance in the samples in-
sion (r=.) as measured with the . The scale
volved, reliability could not be established.
was also related to the Psychosocial Adjustment toIllness Scale (r=.). Similarly, Paci (Paci, )
correlated the psychological distress scale toSpielberger’s Stait Trait Anxiety scale () and
For an instrument to be considered valid it must be
found a strong relationship (r=.). In the Scottish
established whether indeed it is measuring what it is
sample of the Fatigue Study the correlation between
supposed to measure. The main data available from
the psychological distress scale and the
the studies mentioned and from the literature re-
was . for anxiety and . for depression. In a
ported are given in the next overview.
Dutch sample from the normal population (n=)the relation with the - depression score was
Spearman rank correlations between Rotterdam Symptom Checklist (RSCL) and
Medical Outcome Study Short Form (MOS SF-20) (n=60)
1-tailed significance * .01; ** .001.
., in a sample of cancer patients (i.e. the -
The item concerning overall evaluation of quality
study) it was . (Bouma et al., ). In testicular
of life (‘How was your quality of life over the past
cancer papients the relation with the - men-
week?’) has proven, as expected, to be related to
tal health scale was -. (see Table ) (Kiebert, ).
individual domains in the quality of life of cancer
In one of the original Dutch validation studies the
patients under treatment, notably the evaluation of
psychological distress scale was related to per-
physical function (r=. and r=.), the evaluation of
sonality characteristics (De Haes, ). The scale
psychological function (r=. and .), the evalua-
scores turned out to be strongly correlated with
tion of activities (r=.) and the evaluation of social
neuroticism (r=.) and self esteem (r=.) in disease
function (r=.). Similarly, the overall valuation of
free patients as well as cancer patients after treat-
life question proved to be related to individual do-
ment (r=. and -. respectively).
mains in the quality of life of disease free cancerpatients: the evaluation of physical function (r=.),
The activity level scale has turned out to be related
the evaluation of psychological function (r=.), the
to age as expected in a sample from the original
evaluation of activities (r=.) and the evaluation of
Dutch validation study. In the Fatigue study the
social function (r=.). As in the general population
activity level scale was related to fatigue subscales as
it was related to personality characteristics as well. In
expected: in the Scottish data the correlation with
patients under treatment neuroticism correlated
the physical fatigue subscales was ., . and .. As
with overall valuation of life (r=.-. and r=-.) as
expected the correlation between activity level and
well as self esteem (r=. and r=.). The same was
the motivational and cognitive subscales of the
true in disease free cancer patients (r=-. and .
was weaker (r=. and r=.).
respectively) (De Haes, ).
others (Richards et al., ) found cancer-related
An instrument meant to measure the quality of life
symptoms, such as pain and breathlessness, decreased
of patients must not only have construct validity,
over the course of treatment while treatment-related
but must also be able to distinguish between clinical
symptoms, such as vomiting and diarrhoea, increased
characteristics of patients and reflect change in situa-
at weeks and reverted to pretreatment levels after
tions which influence their quality of life 11. In this
paragraph clinical validity or responsiveness is sub-stantiated for the different scales. The psychological distress subscale has in the first place, as reported earlier, proved sensitive to clinical The physical symptom distress as measured with
morbidity as assessed by psychiatric interview in two
the has been found to be responsive to clinical
studies (Hopwood et al., ; Ibbotson et al., ).
characteristics. In the first original Dutch validation
Secondly, the scale was related to clinical events as
study chemotherapy patients receiving cisplatinum
expected in a number of studies. In the original
turned out to experience more gastro-intestinal
Dutch validation studies psychological distress level
symptoms as well as hair loss as expected. In the
has proved to be negatively related to a worse prog-
second Dutch study reported on here, the physical
nosis, receiving chemotherapy, and the expected
symptom distress level was higher in patients receiv-
amount burden of the chemotherapy regimen.
ing chemotherapy and in patients being operated
In the Zebra study as in the study by Jones and
upon for a malignancy compared to the general popu-
Coleman (Jones & Coleman, ) the level of psy-
lation and was worse for patients with a poorer prog-
chological distress was lower after the initiation of
nosis. Patients undergoing chemotherapy reported
hormonal or chemo-therapy. In the Jones and
more physical symptom distress than surgically
Coleman study the patients level of psychological
treated patients and among surgically treated patients
distress, interestingly, deteriorated over the second
physical symptom distress varied with time since the
chemotherapy cycle. Soukop and others (Soukop et
al., ) found patients who received anti-emetic to
In the Zebra study patients were experiencing a
experience less psychological distress. Richards and
higher level of physical symptom distress when they
co-authors (Richards et al., ) found the psycho-
underwent adjuvant chemotherapy in all seven cul-
logical distress scale to differentiate between patients
who received chemotherapy every weeks and those
The Fatigue study can not be used to establish clini-
cal validity as no clinical features were distinguished. In other studies reported in the literature the clinical
The daily activity scale differentiated between can-
validity of the physical symptom distress meas-
cer patients. Patients attending their general practi-
urement has been substantiated. Watson and others
tioner and a general population sample in the original
(Watson et al., ) found the scale to be sensitive
Dutch validation study (De Haes, ). In the Zebra
to the impact of chemotherapy: patients with disease
study, unexpectedly, the activity level of patients
on chemotherapy had significantly higher mean
turned out to be higher after the initiation of
scores for physical distress scale compared to the
disease free group. This difference was greatest forthe scale containing gastro-intestinal symptoms. The overall valuation of life-scale proved sensitive
Soukop and colleagues (Soukop et al., ) found
to a number of clinical parameters in the Dutch
vomiting to be less prevalent, as expected, in patients
validation study. Both surgery and chemotherapy
receiving anti-emetic treatment. Among patients
patients reported an impaired overall valuation of
receiving palliative chemotherapy Richards and
life as compared to the general population. Also
patients with the worst prognosis had the lowest
6 It may be noted that in the original validation study a 27 item version of
quality of life. After surgery the overall valuation of
the symptom checklist was used. In the Zebra and the fatigue study the
life was worse one month after surgery, when there
now accepted version including 30 symptoms has been used.
where clinical problems (e.g. infections) post-sur-gery. Chemotherapy patients reported a worse over-
7 It should be noted that reliabilities depend on the population under study
all valuation when the expected burden of chemo-
(De Haes & Welvaart, 1985). Therefore, the reliability of subscales has to
be computed anew for new studies before these scales are used again.
In the Zebra study the overall valuation of life wasnot impaired after the initiation of therapy in a
8 Using this analysis the norms for reliability are: <.40 is meagre, <.50 is
moderate, >.50 and <1.0 is strong. To conclude, the clinical validity of the ap-
9 The relations given are Pearson correlation coefficients unless stated
The physical distress scales, subscales and individualphysical items differentiate between disease and
10 These data are derived from a study on the quality of life and valuation
treatment states as well as moments of treatment
in testicular cancer patients (Kiebert, 1995).
process. The psychological scale differentiates between cases
11 A problem in establishing clinical validity is that it is not always sure that
and non-cases. Its relation with disease and treat-
indeed the clinical characteristic or situation influences the quality of life as
ment states has to be clarified further on theoretical
expected. Therefore absence of the finding may either mean that the
grounds. The activity level scale differentiates where
instrument is not clinically valid or that the hypothesis has be formulated
expected. The overall valuation is less sensitive, as
erroneously. As will be seen the relation between especially psychological
expected, but still differentiating.
distress and clinical characteristics is not clear yet.
To be able to compare new results with outcomes ofearlier studies, we present data from the study sam-ples mentioned in Chapter (for description ofsamples, see par. .). The scores are transformedinto a - scale as the number of items, as men-tioned earlier, was not the same in the originalDutch validation work. All scales are transformed insuch way that the lower score implies better func-tioning or well-being. Various tumour sites, surgery patients (n = 109)Various tumour sites receiving chemotherapy (n = 108)Various tumour sites, disease free > 3 years (n = 193)Random sample from general population (n = 201)Early breast cancer, before adjuvant treatment (n = 653-688)Early breast cancer, receiving adjuvant treatment, hormonal or chemotherapy (n = 478)Various tumour sites, Dutch sample receiving radiotherapy (n = 98)Heterogeneous, Scottish sample, receiving radiotherapy (n = 134)
Medical Research Council Clinical Trial Data
Lung cancer (n=127). Small cell lung cancer, prior to chemotherapy (MRC LU16)Bladder cancer (n=157). Advanced disease bladder cancer patients, before treatment (MRC BA09)Head and neck cancer, prior to radiotherapy (n=274) (MRC CH01)Various tumour sites, newly diagnosed cancer patients (3 months after diagnosis) n=400Random sample from normal population at T1 (n = 224) Various tumour sites, newly diagnosed cancer patients (15 months after diagnosis) n=400Random sample from general population at T3 (n = 224)In this section a list is given of publications in whichempirical data gathered with the are reported.
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This manual has been published jointly by the
Northern Centre for Healthcare Research, Univer-
sity of Groningen, and the Department of Medical
It would be appreciated, when using the for
Psychology, University Hospital Amsterdam.
screening purposes, that data sets are made available
The can be used under the following condi-
along with data on other instruments useful for
• The source should be mentioned explicitly
• Pharmaceutical companies are asked to contrib-
ute to the ongoing work by giving financial support
• When work using the is published, it is
when using the . In such case please contact
appreciated that a copy of the publication is sent to
prof. Hanneke de Haes, Department of Medical
dr. Robbert Sanderman or to prof. Hanneke de Haes.
Psychology, , Meibergdreef , Amsterdam,
• It is appreciated that data gathered with the
The Netherlands, telephone: (+) -.
are made available for further validation: scores onthe individual items of the checklist, if possible fordifferent age, sex and diagnostic groups. These canbe made available on disc or electronic mail, codedas outlined in this manual.
• Dutch• English• German• Portugese ( versions)• French• Hungarian• Spanish• Tjecho-Slovene• Finnish• Servic
Hieronder vragen wij u in hoeverre u last heeft van een aantal klachten. Het gaater steeds om hoe u zich de afgelopen week voelde. Wilt u een cirkel zetten omhet antwoord dat het meest op u van toepassing is.Bijvoorbeeld: Had U de afgelopen week last vanverminderde sexuele belangstellingHieronder staat een aantal activiteiten. Het is niet van belang of U dezeactiviteiten ook werkelijk doet, maar of U ze kunt uitvoeren in Uw huidigelichamelijke toestand. Het is de bedoeling dat U telkens die omschrijvingaankruist, die het beste past bij Uw situatie van de afgelopen week.zwaar huishoudelijk werk of klusjes doenHoe voelde u zich, alles bij elkaarWilt U nagaan of U alle vragen beantwoord heeft?Hartelijke dank voor Uw medewerking.In this questionnaire you will be asked about your symptoms. Would you please, for allsymptoms mentioned, indicate to what extent you have been bothered by it, by circlingthe answer most applicable to you. The questions are related to the past week.Example: Have you been bothered, during the past week, byHave you, during the past week, been bothered byA number of activities is listed below. We do not want to know whether youactually do these, but only whether you are able to perform them presently.Would you please mark the answer that applies most to your condition of theAll things considered, how would youdescribe your quality of life duringWould you please check whether you answered all questions?
COMISIÓN NACIONAL DEL SERVICIO CIVIL – CNSC- CONCEPTO: No. 2-7-4623-2008 SOLICITANTE: PEDRO DE LA CRUZ ROJAS ACTOS ADMINISTRATIVOS DE LAS COMISIONES DE PERSONAL El señor Pedro de la Cruz Rojas en su calidad de miembro de la Comisión de Personal del ICBF Regional Atlántico solicita se resuelvan los siguientes interrogantes con el fin de cumplir con las norm
Hyclate de Doxycycline en comprimé Quel est ce médicament? La DOXYCYCLINE est un antibiotique de la famille des tétracyclines. Elle détruit certaines bactéries ou arrête leurcroissance. Ce médicament est utilisé pour traiter plusieurs types d'infections, commes les infections dentaires, de la peau,respiratoires et des voies urinaires. Il traite également l'acné, la maladie de Lyme,