A 400-Word History of Quality of Life in 401 Words
FAVORITES ON QUALITY OF LIFE
Dick Joyce PhD, Allschwill, Switzerland
unsolved problem common to the
B rief accounts are notoriously much more difficult to write
field is that of defining the period
than long ones. A 400-word history of Quality of Life (QoL)
over which information relevant to
is impossible. Hence 401.
present or past experience is collected (to-day, the previous
The concept of QoL is frequently held to have been first put forward by architects or other social planners in the 1920s
week
or longer), predicted, or
(see, for example, Maune et al, 2005). However, it was
desired. This has certain analogies
obviously familiar, although not under that name, to
to a problem in the description of
Molière, Ben Jonson and their audiences. Rosser (1993),
personality, and draws attention to
citing Herodotus (5th century BCE), put its Babylonian
“trait”, “state” and even “fate”
origins much earlier (Hammurabi, 17th century BCE) and its
aspects of QoL.
Egyptian origins earlier still (Imhotep, 27th century BCE). With the rapid development of Nearer our own time, millions of
1994;
group:
neurological tracking methods (e.g.,
papers published since the 1960s
O’Boyle et al, 1992; Joyce, 1991).
Smart et al, 2008) already sensitive
purport to have invented, defined
The last of this group considers
enough
or made use of methods for
that QoL is what the individual
“yes”/”no” responses in those with
determining
says
but
“locked-in syndrome” as well as the
193,000,000 hits; or Advanced
impossible to know, what he/she
transmitter-agents for “risk” and
Google Scholar: 1,760,000 hits;
tells him/herself it is).
“reward”, one may expect emphasis
QoL
(Google:
and
it
is
the
Dublin
(better
still,
both accessed 17.02.2010). This
to
have
determined
upon individual QoL, as well as
plethora is partly due on one hand
Within the last thirty or forty years,
attention to theory (Barofsky, in
to
there
preparation) to increase.
the
term’s
application
to
have
been
increasingly
economic, epidemiological or other
thoughtful attempts to combine
social phenomena (in such cases it
the assessment of QoL, Health
Meanwhile,
is better called Health Status, HS)
Related QoL (HRQoL) and HS in
enquiry “How are we to-day?” is
and on the other to the far smaller
instruments that record Patient
probably still the measure of QoL
number of studies on individuals
Reported
most
(see Guyatt et al, 1989; Ruta et al,
difficult but basic and as yet
Outcomes
(PROs).
A
the
commonly
clinical practice.
time-honoured
employed
in
INSTRUMENTS
Revision of the Hospital Anxiety and Depression Scale (HADS) to Produce the Paediatric Index of Emotional Distress (PI–ED) 1
1
Suzy O’Connor , PhD, D.Clin.Psych., Terri Carney , D.Clin.Psych., Emma House1, D.Clin.Psych., Eamonn Ferguson2, PhD, Fiona Caldwell3, MA(Hons), Rory C O’Connor3, PhD 1 2 3
NHS Ayrshire and Arran, Scotland University of Nottingham, England University of Stirling, Scotland
This paper describes the development of a paediatric version of the HADS, the PI-ED. Following a three-phase development, the HADS was revised to render it suitable for children and young people. The revised measure (the PI-ED) was employed in a large-scale standardization school-based study (n=1108) and assessed for diagnostic sensitivity and test-retest reliability in a sample of paediatric out-patients (n=117, data presented elsewhere). Analyses support a measure of overall emotional distress, with anxiety and depression as sub-factors, which is consistent with literature about co-morbidity. The PI-ED offers a valid, reliable, brief, easily scored, cost-effective method to measure emotional distress in children and young people in primary care / hospital, social work or school settings.
Introduction The Hospital Anxiety and Depression Scale (HADS)1 was developed as a valid and
reliable means of detecting anxiety and /or depression in adult patients in nonpsychiatric hospital departments. Items in the HADS pertain specifically to the “psychic” symptoms of anxiety and depression and items that could be confounded with the symptoms of physical illness, e.g., dizziness or headaches were excluded by the scale authors. This measure has excellent psychometric properties (for review2); it is brief, easy to score and interpret and has, as a result, been used widely, for clinical and research purposes. However, to date, no similar measure has been available for use with paediatric populations. This paper outlines the development and evaluation of a paediatric version of the HADS, (the PI-ED). There are few questionnaire measures that are tailored specifically to the medical paediatric population. Measures such as the Children’s Depression Inventory (CDI)3 contain items that are not necessarily relevant for a screening measure in a
KEYWORDS PI-ED, HADS, ANXIETY, DEPRESSION, QUESTIONNAIRE DEVELOPMENT
paediatric population and can cause children and their parents some distress. Depression and anxiety are more prevalent in many paediatric groups, e.g., diabetes4,5, recurrent abdominal pain6, and medically unexplained symptoms7 than in the physically well population of children and young people. However, measures of anxiety and depression that have been available contain items that could present as symptoms of anxiety and / or depression but which may also be symptoms of physical disease, e.g., sore tummy, dizziness and tiredness. There is an increasing incidence of children and young people with chronic medical conditions such as type 1 diabetes mellitus8 and cystic fibrosis9, among many others. Given the higher prevalence of individuals who have physical health issues and their higher risk of depression / anxiety, it seems important to have a measure of emotional distress that is not confounded by somatic symptoms and that has language that is tailored to the needs of this population. This would be useful as a screening measure to guide appropriate intervention, as an index of clinical change and as an outcome measure. Carr10 notes high rates of co-morbidity between major depression and anxiety
Instruments
IN THIS ISSUE
2-4
Revision of the Hospital Anxiety and Depression Scale (HADS) to Produce the Paediatric Index of Emotional Distress (PI–ED) Suzy O’Connor, Terri Carney, Emma House, Eamonn Ferguson, Fiona Caldwell, Rory C O’Connor
11-12 The Child Health Utility 9D (CHU9D) A New, Paediatric, Preference-Based Measure of Health Related Quality of Life Katherine Stevens
Work in progress
5-8
A Questionnaire to Assess Quality of Life in Cancer Patients Undergoing Chemotherapy Josefina C.L. Alonso, Jorge B. Gallestey
Publications... ...............4, 19 News from... ....9-10, 11, 12, 18 Catherine Pouget Award ...16 Conferences/Congresses/ Workshops/Meetings ....19, 20 Key Word Index .................20
Methodology
13-15 A comparison of the WHQ and the BDI-II in a sample of postmenopausal women Marte Rye Heimdal, Annbjørg Dørmænen, Catharina Elisabeth Arfwedson Wang, Sameline Grimsgaard
Results
17-18 Testing Web-based Cultural-Competence Training for Hospice Providers Ardith Z. Doorenbos, Stephanie Myers Schim
2
Patient Reported Outcomes
INSTRUMENTS
disorders in community samples (16%) and the NICE guideline 2811 states that: “In specialist services and community studies depression seldom occurs as a single psychiatric disorder12-14. Concurrent symptoms of anxiety and behavioural disturbances are present in almost all cases and between 50-80% of depressed cases will also meet criteria for another non-depressive disorder”, p. 31, National Clinical Practice Guideline Number 2811. Observed co-morbidity rates have varied between 15.9%-61.9%, perhaps as a result of studies having small samples as well as being derived from community and psychiatric samples15. These high comorbidity rates observed between anxiety and depression, coupled with similar treatment protocols for both, has led to a debate about the utility of the separate classifications of anxiety and depression and a call for the adoption of a unified construct, e.g., “cothymia”16. Such an approach is consistent with Crawford et al17 who re-standardized the HADS to yield clinical cut-off scores for an index of general distress.
Aims: 1. Phase one: to develop a brief measure of anxiety and depression, derived from the HADS, suitable for use with all children and young people, including those with physical health issues. 2. Phase two: to assess, using a large school-based sample, whether anxiety and depression present as a single construct, “cothymia”16, or whether they present as distinct entities. 3. Phase three: consistent with Zigmond and Snaith1, assess the ability of the new measure to detect clinical caseness regarding anxiety and depression by comparing its performance against a “gold-standard” diagnostic measure (NB: these data will be presented elsewhere).
Method Phase one: Development of the items The original HADS items were re-worded by three clinical psychologists who have extensive experience of working with children and young people. Additional items were devised to include key criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR18, and the International Statistical Classification
Revision of the Hospital Anxiety and Depression Scale (HADS) to Produce the Paediatric Index of Emotional Distress (PI–ED) pp. 2-4
of Diseases and Related Health Problems, 10th Revision19. The HADS employs 14 different sets of response categories. For simplicity, these were changed to a single set of response categories. Items were reworded to yield an equal number of positively and negatively valenced questions. The introductory statements from the HADS were rewritten in a concrete and straightforward style. Three focus groups were conducted with children and young people, aged 7–9, 10-12 and 13-16, to check if the measure was meaningful and easy to complete. Items were revised as a result of feedback and the resulting measure was completed by a consecutive sample of children and young people (n=42 paediatric in/out-patients aged between 9-16 years) who also completed two standardized measures of anxiety and depression, the Beck Anxiety and Depression Inventories – Youth 2nd edition20. Following this, further pilot work was conducted to re-examine issues such as the optimal cover page, and final item selection. This process resulted in 16 items for the PIED (7 anxiety and 9 depression), 12 of these were modified from the HADS (7 anxiety and 5 depression) and 4 were new, specially written depression items. Phase two: Large scale standardization of the measure Ethical approval was obtained from the University of Stirling, and the University of Nottingham Department of Psychology ethics committees.
Participants Pupils from 29 schools from Scotland and England participated in phase two. The initial sample comprised 1108 respondents. Fortyseven percent of the sample were female (n=521), 89% of the sample reported their ethnicity as White-UK. Respondents’ ages ranged from 7 to 17 years (mean: 11.93, standard deviation: 2.33). Design The design was cross-sectional. Measures The PI-ED was presented along with the Beck Youth Inventories for anxiety and depression - Second Edition (BYI-II20) for children and adolescents aged 7 to 18 years. These scales include 20 items each
for anxiety and depression and are selfreport measures that take around 10 minutes to complete each. The Beck depression scale includes items on negative thoughts of the self, the future and present. The anxiety scale enquires about fears, worries and anxieties around, for example, the future and school. The BDI-Y and BAI-Y are widely used, reliable and valid measures of mood and anxiety in this population20.
Procedure All primary and secondary schools in Ayrshire and Arran and Nottingham City were contacted by letter. Following a decision by a school to participate, all parents/guardians were sent a letter outlining the nature of study. Participation in the study was on the basis of informed consent. Administration of the measures took place during class time and was facilitated either by a research assistant or by a classroom teacher. Participants were seated apart from each other, given a questionnaire booklet and an envelope to put the completed questionnaire in. Participants were asked not to discuss the questions or their answers. Finally, participants were given a support sheet that provided telephone, postal and electronic contacts for useful organizations (e.g., Young Minds).
Results The detailed findings will be published formally elsewhere. In brief, the data collected during phase two were used to test the psychometric properties of the PIED. This was investigated via ordinal exploratory factor analysis (in LISREL 8.8) and diagonal-weighted least squares confirmatory factor analyses was conducted in LISREL 8.7 with a SatorraBentler Scaled correction and estimated robust standard errors. Half of the sample was used for the exploratory stage and half for the confirmatory stage. Of the initial 16 items, 14 remained after psychometric evaluation and these analyses supported a hierarchical cothymia solution with the symptoms of anxiety and depression loading onto two latent factors of anxiety and depression with these loading on a latent factor of cothymia. This indicates that anxiety and depression are comorbid and that the covariation between them can be explained by a higher order emotional distress factor.
PRO NEWSLETTER 43 (Spring Issue)
3
Revision of the Hospital Anxiety and Depression Scale (HADS) to Produce the Paediatric Index of Emotional Distress (PI–ED) pp. 2-4
Discussion The data in our standardization sample (phase 2) suggest that looking at symptoms of anxiety and depression together in this brief screening measure is more appropriate than viewing the depression and anxiety subscales separately. Schniering et al24 discuss the difficulties in the differentiation of anxiety and depression in children and young people, and argue that they may be elements of the same, higher order construct (negative affectivity25) or that they may be separate, but overlapping, entities. Moreover, it has been suggested that anxiety and depression may be better conceptualized as a single “internalizing’ disorder”26. Alternatively, it may be that anxiety and depression exist along a developmental continuum whereby anxiety presents first followed by depression; epidemiological studies have indicated that anxiety, on its own, is usually evident in younger children whereas a sole diagnosis of depression generally presents later, usually in adolescence27. It seems that there is substantial empirical support for the PI-ED to consider symptoms of anxiety and depression together as a unified construct, whether this is termed “cothymia”, “negative affectivity”, “internalizing disorder”, “emotional distress” or is considered as a developmental continuum. To our knowledge there is not another single measure of emotional distress that assesses symptoms of both anxiety and depression in children and young people. The other measures we are aware of each have a separate form for anxiety and depression that is problematic, given the high co-morbidity rates for anxiety and depression and evidence that they form part of the same higher-order construct. A single form offers economies in terms of the time taken to complete, score and interpret and in terms of purchasing costs. The PI-ED offers initial cut-off scores beyond which a child / young person should receive further clinical assessment. For research purposes, the PI-ED offers a means to quickly measure emotional distress yielding a single score thus minimizing demand on participants and economies in terms of analyses. In short, the PI-ED offers a valid, reliable, brief, easyto-score, cost-effective method to measure emotional distress in children and young people in primary care / hospital, social work or school settings.
4
Patient Reported Outcomes
Contact author: Dr. Suzy O’Connor, NHS Ayrshire and Arran, Ward 1B, Crosshouse Hospital, Kilmarnock, KA2 0BE, Tel: 01563 825760, email: suzy.o’
[email protected].
NB: an extended paper outlining the psychometric analyses in detail will be published elsewhere. 1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatry Scandinavia 1983;67:361-370. 2. Bjelland I, Dahl AA, Haug TT, et al. The validity of the hospital anxiety and depression scale: An updated literature review. Journal of Psychsomatic Research 2002;52:69-77. 3. Kovacs M. The Children’s Depression Inventory (CDI). Psychopharmacology Bulletin 1985;21:995-998. 4. Management of diabetes. SIGN Guideline 55 2001 (November 2001). Retrieved on 18th Jan 2008. Available http://www.sign.ac.uk/pdf/sign55.pdf 5. Type 1 diabetes in children, young people and adults. NICE Guideline CG15 2004 (July 2004). Retrieved on 18th Jan 2008. Available http://www.nice.org.uk/nicemedia/pdf/CG015NICE guideline.pdf 6. Garber J, Zeman J, Walker LS. Recurrent abdominal pain in children: Psychiatric diagnoses and parental psychopathology. Journal of the American Academy of Child and Adolescent Psychiatry 1990;29:648-656.
INSTRUMENTS
21. Shaffer D, Fisher P, Lucas C, et al. NIMH Diagnostic Interview Schedule for Children version IV (NIMH DISC-IV): description, differences from previous versions and reliability of some common diagnoses. Journal of the American Academy of Child and Adolescent Psychiatry 2000;39:28-38. 22. Shaffer D, Fisher P, Lucas C, et al. The NIMH Diagnostic Interview Schedule for Children (DISC-2): description, acceptability, prevalences and performance in the MECA study. Journal of the American Academy of Child and Adolescent Psychiatry 1996;35:865-877. 23. Schwab-Stone M, Shaffer D, Dulcan M, et al. Criterion validity of the NIMH diagnostic interview schedule for children version 2.3 (DISC 2.3). Journal of the American Academy of Child and Adolescent Psychiatry 1996;35:878-888. 26. Schniering CA, Hudson JL, Rapee RM. Issues in the diagnosis and assessment of anxiety disorders in children and adolescents. Clinical Psychology Review 2000;20(4):453-478. 27. King NJ, Ollendick TH, Gullone E. Negative affectivity in children and adolescents – relations between anxiety and depression. Clinical Psychology Review 1991;11(4):441-459. 28. Achenbach TM & Rescorla LA. Manual for the ASEBA Schoolage forms & profiles. Burlington, VT: Univerity of Vermont, Research Centre for Children, Youth and Families. http://www.aseba.org/ 29. Strauss CC, Last CG, Hersen M, et al. Association between anxiety and depression in children and adolescents with anxiety disorders. Journal of Abnormal Child Psychology 1988;16(1):57-68.
7. Husain K, Browne T, Chalder T. A review of Psychological Models and Interventions for Medically Unexplained Somatic Symptoms in Children. Child and Adolescent Mental Health 2007;12(1):27.
PUBLICATIONS…
8. Pitkaniemi J, Onkamo P, Tuomilehto J, et al. Increasing incidence for type 1 diabetes – role for genes? BMC Genetics 2004, 5:5 (2 April 2004). Available http://www.biomedcentral.com/1471-2156/5/5
Handbook of Health Research Methods
9. Liou TG, Rubenstein, RC. Carrier Screening, Incidence of Cystic Fibrosis, and Difficult Decisions. Journal of the American Medical Association 2009;302(23):2595-2596. 10. Carr A. The handbook of child and adolescent clinical psychology: A contextual approach. 2nd edition. Routledge, 2006. 11. NICE National Clinical Practice Guideline Number 28. Depression in children and young people: Identification and management in primary, community and secondary care. National collaborating centre for mental health, The British Psychological Society 2005. 12. Mitchell J, McCauley E, Burke PM, et al. Phenomenology of depression in children and adolescents. Journal of the American Academy of Child and Adolescent Psychiatry 1988;27:12-20. 13. Goodyer IM, Cooper PJ. A community study of depression in adolescent girls. II: The clinical features of identified disorder. British Journal of Psychiatry 1993;163:374-380. 14. Herbert J, Goodyer IM, Altham, PM, et al. Adrenal secretion and major depression in 8- to 16- year olds. II. Influence of comorbidity at presentation. Psychological Medicine 1996;26:257-263. 15. Brady EU, Kendall PC. Comorbidity of anxiety and depression in children and adolescents. Psychological Bulletin 1992;111(2):244-255 16. Tyrer P. The case of cothymia: mixed anxiety and depression as a single diagnosis. British Journal of Psychiatry 2001;179:191-193. 17. Crawford JR, Henry JD, Crombie C, et al. Normative data for the HADS from a large non-clinical sample. British Journal of Clinical Psychology 2001;40(4):429-434(6). 18. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association, 2000. 19. “International Statistical Classification of Diseases and Related Health Problems 10th Revision Version for 2007” (web). World Health Organization 2007. Available http://apps.who.int/ classifications/apps/icd/icd10online/. Retrieved February 26, 2010. 20. Beck JS, Beck AT, Jolly J et al. Beck Youth Inventories 2nd edition for children and young people. Pearson / PsychCorp, 2005.
Ann Bowling and Shah Ebrahim
This handbook helps researchers to plan, carry out, and analyse health research, and evaluate the quality of research studies. The book takes a multidisciplinary approach to enable researchers from different disciplines to work side-by-side in the investigation of population health, the evaluation of health care, and in health care delivery. Handbook of Health Research Methods is an essential tool for researchers and postgraduate students taking masters courses, or undertaking doctoral programmes, in health services evaluation, health sciences, health management, public health, nursing, sociology, sociobiology, medicine and epidemiology. However, the book also appeals to health professionals who wish to broaden their knowledge of research methods in order to make effective policy and practice decisions.
WORK IN PROGRESS
A Questionnaire to Assess Quality of Life in Cancer Patients Undergoing Chemotherapy Josefina C.L. Alonso1, Jorge B. Gallestey2 1 2
Clinical Trials, Institute of Oncology and Radiobiology, Havana City, La Habana, Cuba Center of Atherosclerosis, Higher Institute of Medical Sciences, La Habana, Ciudad de la Habana, Cuba
Abstract Objectives: To validate an instrument which was designed to measure the effect of chemotherapy on quality of life, in cancer patients. Methods: Focus and expert groups were organized. One-hundred-twenty patients were recruited and interviewed at the start and at the end of chemotherapy. The questionnaire was tested for construct, discriminant and convergent validity, and for unidimensionality. Results: The validation process showed that it is internally consistent and reliable, and that it has convergent and discriminant validity. The structural model showed a good fit. The instrument is apt to test the effect of chemotherapy on the quality of life of cancer patients.
Patient outcomes, including quality of life, should be a priority for cancer-therapy guideline development. The development of valid, reliable HRQL instruments is an essential part in the quantification of the physical, social, and psychological distress associated with cancer and its treatment.7-9 HRQL is a “continuum” and treatment cycles can vary in their impact on measures of quality of life. To acquire a complete understanding of the impact of chemotherapy on HRQL, assessment should begin prior to treatment and continue at regular intervals during and after it. 9-11 The purpose of this study is to validate an instrument to measure quality of life in cancer patients in terms of: 1. Reliability and validity. 2. Responsiveness. 3. Unidimensionality. 4. Clinical interpretability.
Introduction The major goal of Health Related Quality of Life (HRQL) questionnaires is to provide a more comprehensive assessment of the health condition of patients, individually or as a group, as well as a more precise evaluation of the costs and benefits that may derive from chemotherapy. Experts in this subject have remarked that traditional methods of assessment are not sensitive to the deleterious effects related to treatment.1-4 The present questionnaire is an attempt to improve the capacity to detect specific effects of chemotherapy on the quality of life of cancer patients. Other general questionnaires address general conditions related to quality of life, but not related to the adverse effects following treatment. Existing questionnaires 5-6 assessing specific effects of chemotherapy would have to be adapted to our cultural and socioeconomic conditions.
5. Burden
Methods
KEYWORDS ADOLESCENTS, HEALTH SERVICES RESEARCH/METHODS, HEALTH STATUS, QUALITY OF LIFE, QUESTIONNAIRES
The composition of the focus groups was as follows: • Gender: Women: 69%; men: 31% • Clinical stage: I: 29%; II: 40%; III: 22%; relapse: 9% • Cancer site: breast: 42%; genito-urinary: 22%; lung: 18%; lymphatic nodes: 11%; head and neck: 7% The first group of experts assigned scores on a five-point scale (with 1 as the least important and 5 the most important) to the complaints, feelings or symptoms identified by the patients. The second group made a final reassessment of items on the basis of the results of the focus groups and the ranking of items yielded by the first group of experts. A set of 72 items was obtained and each item was classified in one of a total of five dimensions: 1. symptoms and signs related to disease and/or treatment (SS); 2. Physical functioning (PF); 3. Emotional functioning (EF); 4. Social and family relationships (SF) and 5. Relationship with partner (RP). Four of these 72 items could not be classified in any of these five dimensions and were included as stand-alone items representing, respectively, working activity (WA), financial difficulty (FD), general selfperceived health (GH) and self-perceived change in quality of life (QoL).
One-hundred-twenty patients were recruited at the National Institute of Oncology and Radiobiology, between January 2005 and August 2006. The inclusion criteria were: (a) patients with cancer diagnosis in breast, lung, ovary and uterus, lymphatic nodes, prostate, or head and neck; (b) who were undergoing chemotherapy; and (c) who were willing to participate in the study. Patients with mental or psychiatric disorders were excluded. Patients were admitted only after informed consent.
Technical expressions containing medical language were rephrased using common every day language. Items were coded on a Likert scale with five options, the highest one representing the best quality of life.. This constructive process yielded a firstdraft version of the questionnaire including 72 items which were later subjected to validation.
To develop the items, two sources of information were used: 1. Eleven fivepatient focus groups, comprising 18 different treatment schemes. 2. Two nominal groups composed of five and six clinical experts, respectively.
A questionnaire was administered to a consecutive sample of 120 patients at the start of chemotherapy. Of these, 85% were women, and 56% were over 50 years of age. As for the distribution according to clinical
This version was tested for face validity using modified Moriyama criteria 12 after which items were either left unchanged, if they fulfilled the criteria, or reformulated. .
PRO NEWSLETTER 43 (Spring Issue)
5
A Questionnaire to Assess Quality of Life in Cancer Patients Undergoing Chemotherapy pp. 5-8
stage, 8% were in stage I, 40% in stage II, 39% in stage III, 10% in stage IV and 3% in relapse. The first measurement was taken a few minutes before chemotherapy. Only 75 questionnaires were completed after chemotherapy. The remaining patients abandoned treatment due to toxicity or change in the chemotherapy scheme. This fact biases downwards the measurement of the toxicity effects. There was less than 10% of missing data in the 75 patients with measurements taken both, at the start and at the end of treatment. The average of the items in each dimension was used as a summary measure of the dimension and to replace missing data in the items of the same dimension. In addition to the overall analogical quality of life index, a summary measure (QoLI) was calculated as the average of the five main dimensions and the four non-grouped items previously mentioned. For each patient, “QoLI” is the average of the 5 five-grouped and the 4 nongrouped dimensions and ranges from 1 (lower limit) to 5 (upper limit), since each item is expressed as a Likert scale ranging from 1 to 5. Reliability was tested by means of the Cronbach alpha coefficient, with a threshold of 0.7 for item reliability.13,14 Criterion-validity: Includes convergent, divergent and discriminating validity. Simple correlations were calculated between each item and the summary measure of its dimension and of other dimensions. Much higher correlations were to be expected between summary measures and items of the same dimension than between summary measures and items of different dimensions. A threshold of 0.4 was taken as expression of a high correlation.13,15 Responsiveness: The instrument was applied on two occasions: before and after chemotherapy. The mean of the standardized response (SRM) was calculated for each dimension.13,15 Responsiveness was calculated by disease status and by selected chemotherapies. Unidimensionality: The fit of all scales to a unique quality of life score was partially confirmed by means of principal
6
Patient Reported Outcomes
WORK IN PROGRESS
The mean age was 53 years old. High school and college level were predominant. Forty percent were in clinical stage III. The more frequent sites for females were breast and gynecologic cancers (57.9% and 21.1%) and, for males, lung (41.2%) followed by prostate cancer and lymphomas (17.6%). The treatment most frequently used was Adriamycin + Cyclofosfamide, Carboplatine + Etaposide and Cisplatin.
component analysis (PCA) and tested by confirmatory factor analysis (CFA) within the Structural Equation Modeling (SM) of LISREL.13,17 Another important attribute of instruments is interpretability. Quantitative scores were transformed to a qualitative scale by the following rule: Severe Impairment: QoLI ) 2; Moderate Impairment: QoLI =) 3 ; Slight Impairment: QoLI = 4 and Normal: QoLI = 5. 13,18-19
Reliability analysis: Cronbach alpha was > 0.7 except for “SF” (table 1). Overall Cronbach´s were 0.92 before chemotherapy and 0.93 after chemotherapy.
Burden: Average time to fill the questionnaire, and non-response rates were calculated. Rates higher than 10% were considered unacceptable.13,20
Face and content validity: The two expert committees issued favorable judgments about the questionnaire regarding relevant aspects of QOL (“SS”, “PF”, “EF”, “SF” and “RP”) as shown by the modified Moriyama criteria.
Results Forty-four percent of all patients were 60 years or more, and 69.1% were women.
Table 1. Global reliability data by dimensions and quality index before and after treatment Alpha Cronbach First measurement Second measurement
Item No
Dimensions “SS” “PF” “EF” “SF” “RP” “QoLI”
36 7 20 3 2 72
0.91 0.79 0.76 0.18 0.71 0.92
0.88 0.81 0.83 0.29 0.77 0.93
Table 2. Average Pearson correlations between items and synthetic summary measures of each dimension Items
“PF”
“SS”
“EF”
“SF”
“RP”
QoLI
“PF” “SS” “EF” “SF” “RP”
0.67 0.37 0.23 0.16 0.30
0.44 0.47 0.19 0.10 0.10
0.31 0.24 0.43 0.30 0.25
0.18 0.09 0.21 0.60 0.30
0.18 0.08 0.16 0.20 0.90
0.51 0.43 0.36 0.30 0.30
Table 3. Quality of life index and its dimensions before and after treatment Before Symptoms
No. items
Digestive Bones-muscles Neurological Respiratory Urinary General
15 2 4 2 3 9
After
Mean
Standard Deviation
Mean
Standard Deviation
4.5 4.3 4.6 4.5 4.5 4.7
0.5 0.8 0.5 0.7 0.5 0.4
3.4 3.8 4.5 4.4 4.1 4.3
0.8 1.1 0.5 0.7 0.6 0.4
A Questionnaire to Assess Quality of Life in Cancer Patients Undergoing Chemotherapy pp. 5-8
WORK IN PROGRESS
Convergent and divergent validity: The items in the five grouped dimensions showed high correlations with the Synthetic Variable (SV) that summarizes their dimension, and also high correlations with “QoLI” except “SF” and “RP”, (Table 2). Correlations with summary measures of dimensions they do not belong to were always lower. This is evidence of convergent and divergent validity. Responsiveness analysis: The chemotherapy effect on “PF”, “EF”, “SF”, “GH”, and “QoLI” was high, as shown by the SRM (Tables 3 and 4). Dimensions “SS” and “RP”, and items “WA”, “FD”, and “QoL”, experienced a moderate effect (below 0.80). Mean “QoLI” decreased for every group of “symptoms”, and there are statistically significant differences “before-after” for the groups of digestive, bones-musclejoints, urinary, and general-system symptoms.
Unidimensionality: Three factors that approximately explained 68% of total variance were detected by principal component analysis (PCA). The first factor approximately accounts for 42% of the variance, and is dominated by the following dimensions: “PF”, “SS”, “EF”, “RP”, “SF” and “GH”. The second one accounts for only 15% of the variance. This result is consistent with the presence of a first dominant factor and other residual factors.
dimensions, despite the fact that supporting measures had to be taken to counteract the toxic secondary reactions to chemotherapy.
Proper unidimensionality was tested by means of a structural path analysis model (Table 5) which was done before and after treatment. The model postulates a single underlying quality of life factor and has a good fit.
Discussion
Interpretability: After transforming “QoLI” to a qualitative scale by labeling its class intervals the instrument was sensitive to a slight decrease in quality of life in all
Burden: At both occasions the nonresponse rate was
