ARTICLE
Auteur(s) : Luisa M
Massimo1, Thomas J Wiley2
1Pediatric Hematology and Oncology Unit G.Gaslini
Children’s Research Hospital, Largo Gerolamo Gaslini, 5, I-16147
Genova, Italy
2Scientific Direction G.Gaslini Children’s Research
Hospital, Largo Gerolamo Gaslini, 5, I-16147 Genova, Italy
Case history
A three-year-old boy, an only child, was referred to us from a
hospital in Central Italy for the treatment of neuroblastoma. The
onset of the disease was recent, and the child presented with
fever, fatigue, pallor, anorexia, upper abdominal mass, bone pain
and tenderness. The boy’s parents, who had moved a few years
earlier to a small Mediterranean island to run a restaurant, led a
relatively carefree life: with their child’s diagnosis and poor
prognosis in hand, they were clearly desperate for support and help
of any kind, and harbored great expectations from our team as one
of the few in the country able to treat their child’s disease.
After a thorough diagnostic work-up, carried out for the most part
under general anesthesia, we were able to decide on the treatment
protocol to start as soon as possible. After detailed briefings
with the parents, informed written consent was asked from both for
the enrolment of their child in a European protocol that included
two randomizations, the first coming three months after initiation
of treatment. Our practice then (as now) was to provide parents
with a simple protocol flow sheet, with which they were free to
provide the suggestions/recommendations of their family physician.
These young parents’ first shock came both from the confirmation of
the diagnosis of a high-risk childhood cancer and the slim chances
for a cure. Unfortunately, they were also utterly unprepared to
handle the two main treatment-related problems: the side effect of
neutropenia linked to the chemotherapy (they knew only about
alopecia), and the prospect of randomization and its meaning. A
randomized controlled trial is always very difficult to explain.
This case was no exception, and we realized at once that we were
faced with two desperate young parents.
At this point, their hopes were gradually transforming into
doubts and fear. Although inclined to return home to care for their
child only with pain control treatment and nursing support, they
nonetheless nurtured the hope that if he lived a few more years a
cure might be found and their boy might survive. This dilemma was
only aggravated by the request to give their written consent to
something they could not completely understand, as well as by the
pressing need to make a decision without any further delay. With
increased attention from us, however, their doubts were mitigated
and they soon learned to cope with this new life and its demands.
Thereafter they began to confide in us more often and more freely.
Their child lived three years longer in rather good condition, and
the entire family learned how to obtain an acceptable
quality-of-life based mostly on bonds of intimacy and trust – not
only with relatives, but also with our medical team.
Discussion
The informed consent process for pediatric oncology research and
treatment protocols is replete with bioethical, psychological and
social issues, all the more so if an RCT is considered [1]. Rarely
are the families of children with cancer prepared for these
implications. The relationships that ensue between the health care
team, parents and children patients, mostly if adolescents, can be
trying and emotionally taxing, with parents’ ability to cope and
adapt often becoming a balancing act influenced by risk and
resistance factors. The literature and the debate on this topic are
plentiful, but regretfully there are still families suffering from
a great distress [2-5]. Brewin, in a pioneering work on the subject
of adult patients’ consent to randomized treatment [6], warned that
giving too much information could be as detrimental as giving too
little. A broader investigation on the same subject was performed
by the Children Cancer Group [7] in 192 parents who accepted or
refused randomization. Although these authors emphasized the need
for further research, they conclude that the parents’ decisions
were impacted mostly by beliefs, values, and perceptions, and not
by information or knowledge.
Similar conclusions were reached by other studies involving
children with diseases different from cancer [8]. Kupst et al. [9]
questioned 20 pairs of parents of newly diagnosed children with
cancer about their perspectives on informed consent through
semi-structured interviews. The results showed that the
experimental nature of clinical trials, and particularly
randomization, was not well understood. Recently Angiolillo et al.
[10] reported on the role that investigators have in the parents’
understanding of the consent process including randomization. They
stress that a consent process with a staged approach can help
investigators obtain a more truly informed consent. On the basis of
our experience we agree with their conclusion.
In order to obtain informed and shared consent, continuous and
open communication from the outset is pivotal: physicians must be
on hand to answer any question parents may wish to ask, and
families may rightly seek the suggestions and support of their
general practitioner, relatives, and other people they trust for
suggestions and support [11]. Communication and the beginning of
the new relationship between the family, the under-aged patient,
and the physician nonetheless arise in a difficult and emotional
setting. Several investigators and teaching hospitals require a
specific new written consent at the time of randomization. We have
noticed that parents asked a second time to give their written
consent within the already authorized protocol are often unprepared
to grasp the implications of this scientifically crucial, but
seemingly unfair mechanism, whereby a computer - not their
physician - selects the treatment. In some cases this mechanism
becomes an unsurmountable enemy.
Ultimately, this unwillingness to consent to randomization may
jeopardize recruitment and validation of trials; a clear example
was seen in the UK by parents’ refusal of randomization included in
the SIOP-MMT-95 protocol for rhabdomyosarcoma [12]. An ethical
question thus arises: is it necessary to ask for consent again at
the time of randomization for patients enrolled in the clinical
protocol? A wholly different matter is the treatment of a child
with relapsing disease, where a new experimental protocol is
recommended. In our previous article on shared informed consent in
pediatric oncology we emphasized that medical students and
physicians-in-training must learn how to communicate, mostly to
deliver bad news [13, 14]: that the attending medical staff must be
versed in approaches to effectively handle the encounters with
families leading to comprehensive shared consent, and should
therefore receive specific instruction in communication, behavioral
and relational skills. Several pediatricians and educators have the
same feeling.
Among the many techniques described for training students and
young physicians, we advocate one of the easiest. Problem-based
learning (PBL), a model elaborated by Guilbert [15] represents an
approach that allows the physician to impart proper and open
information to both families and sick children, mostly adolescents,
through easy-to-understand dialogues with the physician. In this
way the attending medical staff can be versed in approaches to
effectively obtain a shared consent. Using PBL as a guide, the
dialogue between the attending physician, the family and (to the
extent this is feasible) the under-aged patient can be negotiated
and managed as a mutual cognitive process in order to ultimately
elicit truly shared – not only informed - consent including for
randomization.
As could be expected, the most difficult process concerns the
parents’ understanding of the concept of randomization, and the
request for an additional consent to this procedure when they had
already given written consent concerning the whole protocol.
The overall impression we have is that our approach, albeit
uncodified, provides a sound working basis that yields several
benefits. Since the episode described in our case above we have
always endeavored to nurture both the parents’ and our under-aged
patients’ full understanding of protocols and any other procedures
entailed. The model implicitly demands that factual information be
given children and adolescents via simple dialogues with the
physician. This interaction, for all practical purposes, ultimately
becomes a routine part of their life in the hospital. It must be
borne in mind that the informed/shared consent process is not
isolated in the process of caring for the patient but rather is an
integral part of the long term medical team’s endeavor. We strongly
believe that the request for consent should be made only at a
child’s enrolment into an experimental trial, even if it includes
randomization. Sensitive, detailed and easy-to-understand
communication between physicians, professional caregivers, parents,
relatives and the under-aged patient is pivotal to obtaining
comprehensive consent to an experimental trial at the onset of the
disease.
References
1 Rosner F. The ethics of randomized clinical trials. Am J Med
1987 ; 82 : 283-90.
2 Farnell SM. Medical research : why trouble the
patient for informed consent? Med Pediatr Oncol 2002 ;
39 : 207-9.
3 Evans AE. Commentary on "Medical research : why
trouble the patient for informed consent?" by Farnell SM. Med
Pediatr Oncol 2002 ; 39 : 210-1.
4 Massimo LM, Caprino D, Wiley TJ. Commentary on
"Medical research : why trouble the patient for informed
consent?" by Farnell SM. Med Pediatr Oncol 2003 ; 40 :
386.
5 Retsas S. Treatment at random : the ultimate science
or the betrayal of Hippocrates? J Clin Oncol 2004 ; 22 :
5005-11.
6 Brewin TB. Consent to randomized treatment. Lancet
1982 ; 8304 : 919-21.
7 Wiley FM, Ruccione K, Moore IM,
McGuire-Cullen P, Fergusson J, Waskerwitz MJ,
et al. Parents’ perception of randomization in pediatric
clinical trials. Children Cancer Group. Cancer Pract 1999 ;
7 : 248-56.
8 Wallander JL, Varni JW, Babani L, et al.
The social environment and the adaptation of mothers of physically
handicapped children. J Pediatr Psychol 1989 ; 14 :
371-87.
9 Kupst MJ, Patenaude AF, Walco GA,
Sterling C. Clinical trials in pediatric cancer :
parental perspectives on informed consent. J Pediatr Hematol Oncol
2003 ; 25 : 787-90.
10 Angiolillo AL, Simon C, Kodish E,
Lange B, Noll RB, Ruccione K, et al. Staged
informed consent for a randomized clinical trial in childhood
leukemia : impact on the consent process. Pediatr Blood Cancer
2004 ; 42 : 433-70.
11 Oppenheim D, Georger B, Hartmann O. Ethical
issues in pediatric oncology phase I-II trials based on a mother’s
point of view. Bull Cancer 2005 : 92 ; (E??-??).
12 Stevens MCG. National influences on the randomisation of
patients into SIOP MMT 95 study for the treatment of non metastatic
rhabdomyosarcoma. Med Pediatr Oncol 2001 ; 37 : 192.
13 Massimo LM, Wiley TJ, Casari EF. From Informed
Consent to Shared Consent : a Developing Process in Paediatric
Oncology. Lancet Oncol 2004 ; 5 : 384-7.
14 Makoul G. Medical student and resident perspectives on
delivering bad news. Acad Med 1998 ; 73(10Suppl) :
35-7.
15 Guilbert JJ. Educational Handbook for Health Personnel.
6th Edition. Genève : WHO, 1987.
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