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Rscl*

Measuring the quality of life of cancer patients with The Rotterdam Symptom Checklist () Northern Centre for Healthcare Research (NCH) University of Groningen, The Netherlands Department of Medical Psychology, Academic Medical Center Amsterdam; Department of Medical Decision Making, University Hospital, Leiden, The Netherlands Medical Biometrics, University Hospital Freiburg, Germany Medical Research Council, Cancer Trials Office, Cambridge, UK Imperial Cancer Research Fund, Medical Oncology Unit, Western General Hospital, Edinburgh, UK Christie CRC Research Center, University of Manchester, Manchester, UK Northern Centre for Healthcare Research, University of Groningen, The Netherlands Noordelijk 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 study The  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 scores act1+act2+act3+act4+act5+act6+act7+act8 When reversing the activity level and overall valuation of life scale for reasons of consistency the scoring will be 32-(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 1 Internal consistency unless stated otherwise No symptom subscales were identified at this stage Mokken 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=400 Random sample from normal population at T1 (n = 224) Various tumour sites, newly diagnosed cancer patients (15 months after diagnosis) n=400 Random 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. Anderson H, Hopwood P, Prendiville J, Radford JA, De Haes JCJM, Van Knippenberg FCE & Neijt JP.
Thatcher N & Ashcroft L. (). A Randomized (). Measuring psychological and physical dis- Study of Bolus vs Continuous Pump Infusion of tress in cancer patients: structure and application of Ifosfamide and Doxorubicin with Oral Etoposide the Rotterdam Symptom Checklist. Br J Cancer, , for Small-Cell Lung-Cancer. Br J Cancer, , - De Haes JCJM, Van Oostrom MA & Welvaart K.
Ballinger AB, McHugh M, Catnach SM, Alstead (). The effect of radical and conserving surgery EM & Clark ML. (). Symptom Relief and on the quality of life of early breast cancer patients.
Quality-of-Life After Stenting for Malignant Bile- Eur J Surg Oncol, , -.
Duct Obstruction. , , -.
De Haes JCJM, Welvaart K. (). Quality of Life Clavel M, Soukop M & Greenstreet YLA. ().
after breast cancer surgery. J Surg Oncol, , -.
Improved Control of Emesis and Quality-of-Lifewith Ondansetron in Breast-Cancer. Oncology, , De Ruiter JH, De Haes JCJM & Tempelaar R.
(). Cancer-Patients and Their Network - TheMeaning of the Social Network and Social Interac- Cull A, Cowie VJ, Farquharson DI, Livingstone JR, tions for Quality-of-Life. Supp Care Cancer, , - Smart GE & Elton RA. (). Early stage cervical cancer: psychosocial and sexual outcomes of treat-ment. Br J Cancer, , -.
Dobbs NA, Twelves CJ, Ramirez AJ, Towlson KE,Gregory WM & Richards MA. (). Patient Ac- De Haes JCJM, De Ruiter JH, Tempelaar R & ceptability and Practical Implications of Pennink BJW. (). The distinction between Pharmacokinetic Studies in Patients with Advanced affect and cognition in the quality of life of cancer Cancer. Eur J Cancer, A, -.
patients - sensitivity and stability. Qual Life Res, ,-.
Dos Santos MJH, Da Costa FL, Watson M, GreerS, De Haes J, Van Knippenberg F, Pruyn J & Van De Haes JCJM, Pennink BJW & Welvaart K.
den Borne B. (). Adaptaçao psicológica e (). The distinction between affect and cogni- qualidade de vida em doentes oncológicos - Escalas tion. Soc Indic Res, , -.
de avaliao. Psiquiatria Clinica, , -.
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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 gaat er steeds om hoe u zich de afgelopen week voelde. Wilt u een cirkel zetten om het antwoord dat het meest op u van toepassing is. Bijvoorbeeld: Had U de afgelopen week last van verminderde sexuele belangstelling Hieronder staat een aantal activiteiten. Het is niet van belang of U deze activiteiten ook werkelijk doet, maar of U ze kunt uitvoeren in Uw huidige lichamelijke toestand. Het is de bedoeling dat U telkens die omschrijving aankruist, die het beste past bij Uw situatie van de afgelopen week. zwaar huishoudelijk werk of klusjes doen Hoe voelde u zich, alles bij elkaar Wilt 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 all symptoms mentioned, indicate to what extent you have been bothered by it, by circling the answer most applicable to you. The questions are related to the past week. Example: Have you been bothered, during the past week, by Have you, during the past week, been bothered by A number of activities is listed below. We do not want to know whether you actually 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 the All things considered, how would you describe your quality of life during Would you please check whether you answered all questions?

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