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S. Rossi Ferrario1, A.M. Zotti*, C. Pasetti2, F. Comazzi3, I. Giorgi4, M. Negri4, G. Omarini1, P. Omarini1
Communicating medical information: a little lesson
from italian patients
1Psychology Unit, Veruno (Novara); 2Central Ethics Committee, Pavia; 3Bioengineering Unit, Veruno (Novara); 4Psychology Unit, Pavia, Italy
Salvatore Maugeri Foundation, IRCCS, Scientific Institutes, Italy
*Gruppo di lavoro per la costituzione dei livelli di assistenza psicologica e relativi indirizzi operativi-gestionali nella rete sanitaria piemontese.
Assessorato alla Salute e Sanità Pubblica - Regione Piemonte. DD 202/30.4.2009
Introduction
Informed consent in the health context is universally
considered an important instrument to guarantee the re-
spect of a person’s right to understand and participate to
his/her health management. However, many studies in the
world underline that it is used very superficially and, in
most cases, just to assure a legal protection to the health
professional. Iltis (1) refers that there is an overestimation
of people’s understanding, without considering that cogni-
tive “normal” persons who don’t have a specific culture in
the topic have difficulties with medical terms. Many au-
thors have shown that methods to simplify the informed
consents (use of multimedia communication, graphic aids
etc.) do not increase their comprehensibility and that it is
preferable to use different form of communication (verbal,
ABSTRACT. Objective: To construct and validate a questionnaire
that could be used to investigate the clarity of the medical
information received by patients and their satisfaction with it, as
well as their knowledge and opinions concerning advance
directives and their associated variables.
Methods: We administered a 30-item questionnaire to 157 adult
patients affected by progressive neurological, oncological and
nephrological diseases.
Results: The results indicate the good reliability and structure
of the questionnaire, which identifies three factors: “information
and knowledge” (
α
.91), “need for physical and mental support”
(
α
.89), and “determination and decision-making capacity”
(
α
.75). The amount of time dedicated to medical communication
proved to be one of the variables determining the patients’
knowledge of their disease and their capacity to express their
needs, neither of which changed over time. The oldest patient,
a man in the most advanced phase of disease, was the most
fragile in expressing his needs and making decisions. Advance
directives, living wills, active/passive euthanasia and therapeutic
obstinacy1at most only marginally reach the cognitive and
emotional sphere of the patients.
Conclusion: Patients’ needs unequivocally lead us back to the
primary matrices of medical act: paying attention to patients,
offering adequate time, listening to him/her concerns and asking
when no question emerges. This so obvious evidence does not
match with the increasingly techno-oriented attitude of health
professional, who also have to guarantee more productivity in
less time. The quality of medical information received by patients
impacts their decision making process, particularly in the oldest
people. In Italy, as well as in other countries, it is necessary to
pay more attention to this issue, keeping in mind that nobody can
really choose without knowing exactly what it is going to happen.
Key words: medical information, communication, questionnaire
RIASSUNTO. COMUNICARE INFORMAZIONI MEDICHE:
UNA LEZIONE DA PAZIENTI ITALIANI. Obiettivo: Il diritto
all’informazione medica e il testamento biologico costituiscono,
tuttora, in Italia, argomenti di dibattiti e controversie.
Tuttavia, poco si conosce sulle conoscenze e sulle opinioni dei
cittadini, specie se malati.
Il nostro lavoro, senza avere la pretesa di esaudire la necessità
di chiarezza su tale lacuna, né di pervenire a generalizzazioni,
si propone di offrire alcune indicazioni meritevoli certo di
ulteriori approfondimenti.
Metodo: È stato costruito un questionario di 30 item per
indagare la chiarezza delle informazioni mediche ricevute,
bisogni, conoscenze e opinioni sulle direttive anticipate. Il
questionario è stato somministrato a 157 soggetti adulti, affetti
da malattie croniche progressive diverse (neurologiche,
oncologiche e nefrologiche).
Risultati: I risultati hanno evidenziato soddisfacenti proprietà
psicometriche del questionario che identifica tre
fattori:”informazioni e conoscenze” (α.91), “necessità di
supporto fisico e psicologico” (α.89) e “determinazione e
capacità di processo decisionale” (α. 75).
L’analisi di tali costrutti rispetto a variabili sociodemografiche
e di processo ha evidenziato che il tempo dedicato dal medico
è una di quelle che determina il grado di conoscenza della
malattia da parte del paziente così come la sua capacità di
esprimere i propri bisogni. Genere, sesso e stadio di malattia
sono altrettanto influenti: il paziente più in difficoltà in questo
senso è risultato essere parkinsoniano, anziano, di sesso
maschile e in fase avanzata di malattia.
Conclusioni: Relativamente ai concetti di direttive anticipate,
eutanasia e accanimento terapeutico, essi sembrano ancora
difficoltosi da elaborare sia sul piano cognitivo che affettivo
dalla maggioranza dei pazienti del presente studio.
In conclusione, qualunque decisione normativa in merito,
come il consenso informato o il testamento biologico,
continuerà ad essere solo un atto formale se non si
riconsidererà sul piano comunicativo il processo, non solo
informativo, che fonda la capacità decisionale in merito alla
salute. L’uso del questionario proposto può essere una buona
occasione per riflettere.
Parole chiave: informazione medica, comunicazione. questionario.
Giornale Italiano di Medicina del Lavoro ed Ergonomia Supplemento B, Psicologia
©PI-ME, Pavia 2009 2009; Vol. 31, N. 3: B12-B16
http://gimle.fsm.it ISSN 1592-7830
1The neo-Latin term “accanimento terapeutico”, which is very well known and widely used in Italy, has been translated as “therapeutic
obstinacy”, “over-treatment”, “aggressive medical treatment” and “futility” (for example, see ref.1). We have chosen the first translation as it seems to
us to be clearer and less ambiguous than the others.
G Ital Med Lav Erg 2009; 31:3, Suppl B, Psicol
http://gimle.fsm.it B13
written etc.) (2). Certainly, time dedicated by the health
professional to the patient has been proved to be an im-
portant variable in influencing a better decision making
(3). The problem is even more difficult regarding living
wills and advance directives: they have been studied in
some European countries, such as The Netherlands and
Denmark, where they are already subject to legislative
regulation, but they have not been studied in Italy despite
a long and active debate concerning the principles of “pa-
tient autonomy”, “freedom of choice” and the “right to in-
formation”. In fact, there is still controversy and even
open conflict concerning advance directives which in-
volves the political parties, the religious agencies and the
health professionals themselves (4,5). Surprisingly, there
are no studies evaluating whether the medical information
given as the basis of informed consent is actually clear to
patients, or assessing their knowledge and opinions con-
cerning advance directives and the related variables.
The aim of this study, which was approved by our In-
stitute’s Ethics Committee, was to construct and validate a
questionnaire that could be used to make a first study.
Methods
Two of the authors (Pasetti & Zotti, the first a neurol-
ogist with experience in bioethics, and the second a psy-
chotherapist with experience in chronic diseases) formu-
lated the questionnaire in order to explore:
–patients’ awareness and knowledge of their disease;
–the amount and quality of the information received
concerning its diagnosis and evolution;
–their wishes concerning the treatments that can be ad-
ministered to them in the case of decision-making in-
capacity;
–the types of mental and physical support needed in in
relation to different personal values and wishes.
In a first phase, the questionnaire (which included an
introductory note explaining the meaning of “advance di-
rectives” and a page for collecting demographic data) con-
sisted of 51 items with responses based on a 3-point scale
(from 1 = not at all, to 3 = completely). This version was
administered to 40 patients with different chronic diseases
who were hospitalised for rehabilitation purposes. Imme-
diately after its administration, the subjects were asked
about their understanding of the items, and their respons-
es to the questionnaire underwent frequency and distribu-
tion analysis. After deleting the items that had been poor-
ly understood and those that had not achieved a discrimi-
nating capacity (Kurtosis >+l o >-l), the revised question-
naire (called ‘Communication and Consent’) consisted of
46 items, and was used in the present study.
Over a period of two months, and after having ob-
tained their informed consent, we enrolled 157 consecu-
tive patients attending outpatient appointments because of
Parkinson’s disease (PD), chronic renal insufficiency (RI),
or neoplasms of various origin (NEOP). The exclusion cri-
teria were the presence of any obvious alterations in cog-
nitive capacity or treatment with psychoactive drugs capa-
ble of impairing consciousness or the level of vigilance.
The questionnaire was administered by health person-
nel with experience in psychometrics who were not in-
volved in caring for the patients.
Statistical analysis
The responses to the multiple-choice items of the ques-
tionnaire underwent factorial analysis by means of extrac-
tion of the principal components, a scree test, and analysis
of internal consistency (Cronbach’s α). Analysis of vari-
ance, Covariance by age, Student’s ttest, and Bonferroni’s
post hoc test were used to evaluate the intervening effect
of the correlated socio-demographic and disease variables.
Results
Table I shows the patients’socio-demographic charac-
teristics distributed by disease type: 65 (41.4%) were af-
fected by Parkinson’s disease (PD), 43 (27.4%) by chron-
ic renal insufficiency (IR) treated with dialysis, and 49
(31.2%) by intermediate or advanced neoplasms of vari-
ous origin (NEOP) not yet in terminal phase. Mean dis-
ease duration from the time of diagnosis was 69.5 ±71.1
months (range 1-372).
The patients’ mean age was 63 ±13.4 years and 58.6%
were female; 65% were married, 66% retired, 45% had
had eight years’ education, and 95.5% were Catholics.
Given the convenience sample and different diseases,
the mean ages of the groups were significantly different
(F=31.66; p<.0001), with a preponderance of elderly sub-
jects among the PD patients. The subsequent analyses
were made bearing this in mind.
3.1 Analysis of the constructs
Afirst extraction factorial analysis of the principal com-
ponents of the multiple-choice items indicated that 41% of
the variance was explained by three factors, and the scree
test (see Fig. 1) and analysis of factorial weights suggested
excluding the items with a factor loading of less than .30.
The subsequent factorial analysis of a total of 29 items
(Tab. II) again identified three factors, but these explained
52.44% of the total variance2.
The first factor consisted of 18 items with a degree of
internal consistency of .91 (Cronbach’s α), and was called
“Information and knowledge”; the second consisted of six
items with an αof .89, and was called “Need for physical
and mental support”; and the third consisted of five items
with an αof .75, and was called “Determination and deci-
sion-making capacity”.
Table III shows the distribution characteristics of the
three factors in the sample as a whole. Gender significantly
differentiated (t=2.09; p<.03) the factor Need for physical
2The final version of the questionnaire is in Appendix. Item 6 “When you were told the diagnosis, how much time were you given to talk about
your disease?” was always removed from analysis.
G Ital Med Lav Erg 2009; 31:3, Suppl B, Psicol
http://gimle.fsm.it
B14
and mental support, with males being less capable of cop-
ing than females. Age (<67 vs ≥67 years) significantly dif-
ferentiated both the first (t=2.66; p<.009) and the third fac-
tor (t=2.35; p<.02), with the oldest subjects having less in-
formation and decision-making capacity. Education (ex-
pressed in years) significantly differentiated both informa-
tion (F=4,22; p<.01) and determination and decision-mak-
ing capacity (F=6.92; p<.001), with lower scores among
the subjects with only primary education.
The disease was the variable that determined the dif-
ferences between the scores of all three factors (Table IV).
Analysis of variance showed that the subjects with PD
were less informed (F=19.72; p<.0001), less capable of
defining the support necessary (F=12.38; p<.0001), and
had less decision-making capacity (F=8.5; p<.0001) than
those with RI or NEOP, who did not differ
from each other at the post hoc test. These re-
sults are even confirmed by considering pa-
tients’ age as covariate: PD patients, in fact,
showed results significant different from the
other subjects (F=3.751; p<.05).
The time since the initial diagnosis of the
disease (divided on the basis of a median of
<48 and ≥48 months) did not seem to influence
any of the constructs significantly, whereas the
stage of disease did: the more advanced the
disease, the less the need for information
(F=6.39; p<.002) but the greater the need for
physical and mental support (F=3.39; p<.03).
Analysis of the individual items
It is interesting to note that, contrary to
expectations, qualitative analysis of the indi-
vidual items showed that the subjects’ Gener-
al Practitioner was not their direct interlocu-
tor in terms of disease management (7.2% of
the sample as a whole): 82.5% had received information
about the disease from a specialist, and 4.6% had entrust-
ed their knowledge to searches in magazines and the on
the Internet. Only 41.7% considered that they really knew
about their disease and its evolution. The medical time
dedicated to communicating the diagnosis was less than
ten minutes for 37.7% of the subjects, thus creating a
greater need for information (F=21.59; p<.0001) and
physical and mental support (F=3.22; p<.04) in compari-
son with the patients who had had more than ten minutes
of dedicated time.
Almost all of the patients expressed their belief in the
right to know the truth about their disease and a physician’s
duty to inform them even in the case of a progressive dis-
ease with a poor prognosis. Finally, 93.5% declared that
Table I. Sociodemographic characteristics of the study sample by type of disease
PD RI NEOP TOTAL
(n = 65) (n = 43) (n = 49) (n = 157)
Age (years) 71.4 ± 6.1 60.7 ± 13.8 54.7 ± 14.1 63.2 ± 13.4
Gender M 30 (46.2%) 20 (46.5%) 15 (30.6%) 65 (41.4%)
F35 (53.8%) 23 (53.5%) 34 (69.4%) 92 (58.6)
Education in years <543 (68.3%) 19 (45.2%) 9 (18.4%) 71 (46.1%)
813 (20.6%) 14 (33.3%) 13 (26.5%) 40 (26.0%)
13 6 (9.5%) 9 (21.4%) 19 (38.8%) 34 (22.1%)
>13 1 (1.6%) 8 (16.3) 9 (5.8%)
Marital status Single 7 (16.3%) 5 (10.2%) 12 (7.6%)
Married 39 (60%) 27 (62.8%) 36 (73.5%) 102 (65%)
Divorced 1 (1.5%) 1 (2.3%) 4 (8.2%) 6 (3.8%)
Widowed 25 (38.5%) 8 (18.6%) 4 (8.2%) 37 (23.6%)
Occupation Employed 3 (7.0%) 24 (49%) 27 (17.2%)
Housewife 8 (12.3%) 11 (25.6%) 7 (14.3%) 26 (16.6%)
Retired 57 (87.7%) 29 (67.4%) 18 (36.7%) 104 (66.2)
Disease length (months.) 80.9 ± 60.6 87.7 ± 94.3 38.4 ± 47.6 69.5 + 71.1
Self-evaluation of disease severity/stage Initial 25 (39.7%) 8 (18.6%) 9 (20.0%)
Moderate 25 (39.7%) 20 (46.5%) 23 (51.1%)
Severe 13 (20.6%) 15 (34.9%) 13 (28.9%)
Figure 1. Factor analysis: scree plot
G Ital Med Lav Erg 2009; 31:3, Suppl B, Psicol
http://gimle.fsm.it B15
they did not even approximately know the meaning of “ad-
vance directives” and, although the word “euthanasia” was
well known by 83% of the subjects, “therapeutic obstina-
cy” and “invasive therapy” proved to be less clear (not
known by respectively 49.3% and 58.3%).
After having had the meaning of “advance directives”
explained to them, 11.6% of the subjects did not consider
them a useful means of safeguarding their wishes and
were unwilling to use them; half of the 42.5% who were
totally in favour of the use of a card indicating one’s wish-
es in the case of a disease with a poor prognosis were in
the NEOP group.
Discussion
The proposed questionnaire, reduced to a total of 30
items, proved to be valid and reliable, and immediately ca-
pable of providing ethically important findings. It identi-
fies differences arising from socio-cultural variables as
well as some critical aspects of medical practice. As pre-
viously revealed by other studies (6,7), it was found that
dedicated medical time is one of the variables determining
the amount of information patients have about their dis-
ease and their capacity to express their needs, which do
not change over time.
It also emerged that General Practitioners do not seem
to play a prominent role in accompanying patients through
the management of progressive chronic diseases and,
paradoxically, provide less information then the Internet.
Finally, it was found that older male patients in the
most advanced stage of disease are the most fragile in ex-
posing their needs and taking decisions, which it is proba-
ble they cannot make also because they do not know about
outcomes. Fried et al. (8) also point out that especially el-
derly patients’ decisions concerning treatment depend on
how much they know about their possible results.
The large questions, such as advance directives, living
wills, active/passive euthanasia and therapeutic obstinacy,
which in Italy are shaking political debate and the medical
world (5), only marginally enter the cognitive and emo-
tional spheres of patients. However, even in the USA,
where the federal Act of Self-determination goes back to
1990, and where the last decade has seen referendums held
and special laws enacted, there is still confusion concern-
ing the meaning of some terms and the available options
(9,10). Once again, communication and dedicated time
prove to be an essential condition for the promulgation and
especially the application of ethical-juridical principles.
People suffering from precarious and worsening clinical
conditions seem to be more favourably inclined to the adop-
tion of a card indicating their wishes in the case of a disease
with a poor prognosis. This has also been highlighted by
other European authors, who have pointed out that debates
and laws are not sufficient to increase knowledge and over-
Table II. Factor loading of each item of the questionnaire
(see Appendix)
Factor 1 Factor 2 Factor 3
Item 5a .778
Item 5b .767
Item 5e .766
Item 8a .744
Item 5d .726
Item 5c .714
Item 8c .698
Item 5f .677
Item 8b .672
Item 4 .664
Item 8d .586
Item 7 .526
Item 10c .507
Item 10a .488
Item 2 .471
Item 14d .463
Item 3 .460
Item 1 .444
Item 13a .729
Item 13c .722
Item 13b .667
Item 14a .638
Item 14c .626
Item 14b .618
Item 11 .795
Item 12 .790
Item 15 .521
Item 9 .464
Item 10b .431
Table III. Psychometric characteristics of the investigated constructs (sample as a whole)
Mean SD Median Mode Range Skewness Kurtosis αCronbach
Information and knowledge 44.8 8.37 46 54 23-57 –.446 –.598 .91
Need for physical 12.9 4.02 12 18 6-18 –.201 –1.197 .89
and mental support
Determination and 11.1 2.53 11 9 5-15 .093 –.962 .75
decision-making capacity
Table IV. Analysis of the constructs by type of disease
PD (n = 65) RI (n = 43) NEOP (n = 49) p <
Information and knowledge 38.5 ± 7.5 47.8 ± 7.3 47.1 ± 7.3 .0001
Need for physical and mental support 10.5 ± 3.6 13.4 ± 3.6 14.4 ± 3.9 .0001
Determination and decision-making capacity 9.8 ± 2.2 11.1 ± 2.7 12.1 ± 2.2 .0001
G Ital Med Lav Erg 2009; 31:3, Suppl B, Psicol
http://gimle.fsm.it
B16
come ambivalence, and that only worsening health favours
a wish for self-determination (11).
The diseases considered in our study certainly repre-
sent one of its limitations because of the characteristics of
the people affected by them: patients with Parkinson’s dis-
ease are older and less educated than those affected by
cancer but, as described above, this did allow us to verify
the discriminating capacity of the questionnaire. Other
studies are therefore necessary, involving patients with
other diseases, healthy subjects, and caregivers.
Some studies have shown that caregivers declare a con-
tinuing need for clarity concerning disease management
and that, although they think about the possible death of
their partner, they find it very difficult to talk about and live
the resulting emotional state in solitude (12, 13).
Conclusions
Ethics and deontology suggest that the current major
issues are communicating with patients and the quality of
life. As shown by our study, patients’ needs unequivocally
lead us back to the primary matrices of the medical act in
its most exquisitely anthropological sense: paying atten-
tion to patients, offering information that is compatible
with their education, and knowing how to interpret needs
even when patients are incapable of asking. Time, a syn-
onym of productivity and efficiency in a society that is in-
creasingly characterised by the prevalence of techno-sci-
ence, seems to be a clearly disturbing element when tak-
ing responsibility for a patient with a chronic disease as it
impedes the establishment of a doctor-patient relationship
founded on a therapeutic alliance and truly global sup-
portive care. The British Medical Journal has recently
dedicated considerable space to discussing the incompre-
hensibility of informed consent (14), but is it like that
merely transforming technical language into “friendly”
language will be enough to overcome the problem?
Recovering the language of clinical relationships does
not mean adopting anti-scientific attitudes, but simply re-
introducing ontology and considering the social dimension
of disease and dying (15-16), while being aware that pub-
lic debate and regulations can only constitute a generic cul-
tural base that then needs to be modelled on the individual.
This is all the more important, the more one has rela-
tionships with patients who can and must decide what they
are prepared to accept in therapeutic or palliative terms,
prolongation or discontinuation - in other words in terms
of the quality of life and the quality of death.
Practice implication
Although it is known that the quality of medical infor-
mation received by patients impacts their decision making
process, in Italy, as well as in other European countries
and in USA, we continue to observe that the informed
consent is, in general, a little comprehensible instrument.
The same seems to happen with the advance directives.
Many authors call for more attention to this issue and there
is a general agreement about the importance of time dedi-
cated to communication and of the frontal relationship, es-
pecially in discussing the consequences of medical acts.
Health professionals should try to make this evidence a re-
al daily practice.
Acknowledgements
The authors would like to thank Kevin Smart (Link srl)
for his assistance in preparing the manuscript. The study
was funded by S. Maugeri Foundation, and the authors de-
clare that they have no conflicts of interest.
References
1) Iltis A. Lay concepts in informed consent to biomedical research: the
capacity to understand and appreciate risk. Bioethics 2006; 20(4):
180-190.
2) Cohn E. & Larson E. Improving participant comprehension in the
informed consent process. J of Nursing Scholarship 2007; 39(3):
273-280.
3) Hansson MG, Kihlbom U, Tuvemo T, Olsen LA, Rodriguez A.
Ethics takes me but not that long. BMC Medical Ethics 2007; 39(3):
273-280.
4) Spinsanti S. Bioethics: emerging problems and perspectives. Recen-
ti Prog Med 2006; 97(10): 580-6.
5) Turone F. Italy debates end of life decisions BMJ 2006; 333: 719.
6) Shilling V, Jenkins V, Fallowfield L. Factors affecting patient and
clinician satisfaction with the clinical consultation: can communica-
tion skills training for clinicians improve satisfaction? Psychooncol-
ogy 2003; 12(6): 599-611.
7) Cape J. Consultation length, patient-estimated consultation length,
and satisfaction with the consultation. Br J Gen Pract 2002;
52(485): 1004-6.
8) Fried TR, Bradley EH, Towle VR, Phil M, Allore H. Understanding
the treatment preferences of seriously ill patients. N Engl J Med
2002; 346(14): 1061-66.
9) Thorevska N, Tilluckdharry L, Tickoo S, Havasi A, Amoateng-Ad-
jepong Y, Manthous CA. Patients’ understanding of advanced direc-
tives and cardiopulmonary resuscitation. J Crit Care 2005; 10(1):
26-34.
10) Freer JP, Eubanks M, Parker B, Hershey CO. Advance directives:
ambulatory patients’ knowledge and perpectives. Am J Med 2005;
119(12): 1088-e9-13.
11) Sahm S, Will R, Hommel G, Attitudes towards and barriers to writ-
ing advance directives amongst cancer patients, healthy controls,
and medical staff. J Med Ethics 2005; 31(8): 437-40.
12) Rossi Ferrario S, Zotti AM, Ippoliti M, Zotti P. Caregiving-related
needs analysis: a proposed model reflecting current research and so-
cio-political developments. Health and Social Care in the Commu-
nity 2003; 11(2): 103-110.
13) Rossi Ferrario S, Cardillo V, Vicario F, Balzarini E, AM Zotti. Ad-
vanced cancer at home: caregiving and bereavement. Palliative Med
2004; 18: 129-136.
14) AAVV. Incomprehensible consent forms, BMJ 2005: 330.
15) Martin DK, Emanuel LL, Singer PA. Planning for the end of life.
The Lancet 2000; 356: 1672-76.
16) Pasetti C. Bioethics and caregiving: a critical interaction in patient care
today G Ital Med Lav Ergon. 2008 Jul-Sep; 30(3 Suppl B): B10-4.
Reprint request: Silvia Rossi Ferrario, Psychology Unit, Scientific Institute of Veruno, I-28010 Veruno NO, Italy - Phone: +39 0322 884781,
Fax: +39 0322 884815, E-mail: silvia.ferrario@fsm.it