原著論文

Psychological Processes Experienced by Patients with Dilated
Cardiomyopathy Participating in a Clinical Study:
a qualitative study
Etsuko Arita＊１, Yutaka Ishii１，２, Noriko Ando-Tanabe１，３,
Akiyasu Baba４，５
Keyword ; clinical study participation, psychological process, therapeutic misconception, qualitative study
Abstract ; Background: Dilated cardiomyopathy（DCM）is a progressive disease of the heart muscle. Standard
treatment mainly comprises of treating the symptoms of heart failure, so the development of effective therapies isurgently required. Patients with an intractable disease such as DCM are seeking new treatments for clinical studies.
Some patients may confuse the research process for treatment, and therefore this misconception could result in an
ethical problem of participation. In order to solve the therapeutic misconception, it is important to understand thepatients psychological state, but there are few preceding studies. This study aimed to reveal the psychologicalprocesses in DCM patients by examining their personal experiences of clinical studies．
Methods: In total 11 DCM patients who visited the Kitasato Institute Hospital of Kitasato University for follow-up
examination of the clinical study on immunoadsorption therapy from April 2011 through May 2012 were participatingin this study. They participated in semi-structured, open-ended and in-depth interviews that surveyed their
psychological process with clinical study participation. Patientsʼ narratives were recorded and interview data wascategorized using a qualitative analysis method．
Result: A total of 19 concepts were generated and grouped into categories. Patients have high expectations regarding
clinical study participation, not only for the experimental treatment but also with respect to medical staff involved in
the clinical study. Clinical studies strongly impact the awareness of participants towards treatment．
Conclusion: DCM patients had strong expectations about participating in this Clinical study. In order to solve thetherapeutic misconception, it is important to understand the patients psychological state. So that we can work
towards supporting them in their intractable diseases. This study may be informative the importance to understandthe psychological statement of the intractable disease patients．
１ Department of Medical Psychology, Pharmaceutical Education Center, Kitasato University School of Pharmacy
２ SOGO MEDICAL CO., LTD．
３ Department of Genetic Medicine and Services, National Cancer Center Hospital
４ Kitasato University Kitasato Institute Hospital
５ Department of Cardiology, Ichikawa General Hospital, Tokyo Dental College＊Corresponding Author: E tsuko Arita, Ph.D., 5-9-1, Shirokane, Minato-ku, Tokyo, 108-8641 Japane-mail：aritae@pharm.kitasato-u.ac.jp

4Introduction

participate in clinical studies is impacted by

Patients with intractable disease such as

this experience６，７，８）. When performing a

dilated cardiomyopathy（DCM）are seeking

clinical study involving patients with intrac-

new treatments for clinical studies. On thetable diseases, such as those with DCM

other hand, the therapeutic misconception（which imposes a high therapeuticis an ethical problem. In order to conduct

burden）,the physical and psychologicalclinical research ethically, it is important toimpact on these patients must be

understand the participantʼs psychology forconsidered, more so than in general clinicalthe clinical studies. The present study

studies. Despite this, very few studies haveaimed to reveal the psychological processes

examined the psychological impact onin DCM patients by examining theirpatients. Among the few qualitative studies

experiences of clinical studies. DCM is afocused on the psychological processes ofcondition characterized by poor prognosis,

clinical study participants with intractable

marked expansion of the cardiac lumen,diseases is a study by Kohara et al., which

and advanced contractile dysfunction,

examined the decision-making process

resulting in severe congestive heart failure

experienced by cancer patients concerningand refractory arrhythmia. Standard

participation in a phase I clinical study６）．

treatment mainly comprises treating the

In the present study, we focused on

symptoms of heart failure and the preven-psychological processes in patients withtion of further disease progression １）. As

DCM, an intractable disease, by examining

such, development of effective therapies istheir experiences with clinical study

urgently required and potential causes

participation. The results of this study

must be elucidated. Currently, clinicalshould help provide psychological support

studies on immunoadsorption therapy２，３）

to patients with intractable diseases and itʼs

and stem cell therapy ４）are ongoing as

also useful for medical professionals toadvanced treatments for DCM．

understand a patient．

Research interests in current medical
development have shifted toward studies of

Methods

intractable diseases, in consideration of thePatients and Recruitment

awareness of unmet medical needs. Clinical

DCM patients who visited the Kitasato

studies on intractable diseases are thus of

Institute Hospital of Kitasato University forincreasing importance, even for those who

follow-up examination of the clinical study

conduct such studies. Among bothon immunoadsorption therapy from April

participants and researchers, the demand

2011 through May 2012 were included infor clinical studies of intractable diseases isthis study. The criteria of this clinical study

high, and the number of conducted studies

were as follows:（1）diagnosis of DCM,（2）has been on the rise ５）and is expected tograde ≥3 subjective symptoms of heart

increase further in the future．

failure according to the New York Heart

Previous reports have demonstrated that

Association functional classification,（3）left

the mental health of patients whoventricular ejection fraction of ≤35％,（4）
5

原著論文

receiving optimal treatment for heart

・W h a t d i d y o u t h i n k a f t e r t h e

failure with no improvement in medical

explanation？

condition for more than three months, and・What did you think before you decided to（5）age ≥18 years．

participate？
・W h a t d i d y o u t h i n k u n t i l t h e c l i n i c a l

Procedures

study？

An interview survey was conducted at the・What did you think among the clinicaltime when immunoadsorption therapy wasstudy？

completed, i.e., the main part of the clinical・After the clinical study, what did you

study, when the participants visited ourthink？

hospital for follow-up examination. Semistructured interviews led participants to

Qualitative Analysis

talk about events related to DCM as well as

Analyses utilized the modified grounded

their psychological experience from thetheory approach（hereafter, M-GTA）,atime when they noticed symptoms up toqualitative research method suited forthe present day. The semi-structured

qualitative data analysis. The M-GTA has

interview method used for data collection is

excellent explanatory power for humanbased on an approach wherein the

behaviors related to social interaction andquestions, although predetermined to ademonstrates analytical strength within acertain extent, could be adjusted flexibly tolimited range, and is thus consideredelicit more in-depth responses depending on

effective in the field of human services 10）.

the question. This method allows the

Furthermore, as a rough standard, it caninterviewer to accommodate thesummarize results using data from as few

respondentʼs worldview easily and discussa s 1 0 c a s e s 1 0 ）. O u r a n a l y s i s t a r g e t e d

new ideas on this theme９）．

patients with DCM who participated in aclinical study, and focused on “psychological

Questionsprocesses experienced there in by patients

In semi-structured interviews, we asked

with DCM.” From the qualitative data, weparticipants these questions．

extracted contents worth noting in

Examplessentence form, and each of these was・What did you think about your illness

treated as an “example” to which awhen you were diagnosed？

“concept definition” was appended based on・What did you think about your treatment

its inferred meaning, along with a title

before you know this clinical study？

generated as a “concept.” Moreover, any

・How did you know about this clinicalother content that appeared to correspondstudy？

to the generated concepts was extracted

・When you know this clinical study, howfrom the qualitative data and included in

did you think about it？

the originally extracted examples. In each・W h y d i d y o u d e c i d e t o r e c e i v e a ncase, consistency between the example andexplanation of this clinical study？

its definition as well as concept was
6examined. Furthermore, the opposite

were used as qualitative data in themeaning of the generated concept was

subsequent analysis. Mean interview

considered and incorporated in this process,duration was 38.4±34.6 minutes（range,

so as to prevent the viewpoint from being

15-76 minutes）．

skewed. As a result, concepts that did not

A total of 19 concepts were generated andmatch multiple corresponding examples

g r o u p e d i n t o c a t e g o r i e s（ T a b l e 1 ）.T h efrom participants were disregarded as

results are summarized in diagram（ Figure

unfounded, or new concepts were

1）and described in the storyline below．

generated that embodied other examples.
These analyses were conducted repeatedly

Explanations of generated concepts

for all data until no further generation of［Sense of lack in medical technology］

concepts was possible. These analyses

Patients felt that the medical care theygenerated concepts for which a minimum

desired was not available to them. In thelevel of validity was guaranteed.

case of one patient, it can be inferred that

Furthermore, a diagram of results

the patient did not even acknowledge theillustrating the concepts and categoricalprevious treatment as a therapeutic

relationships between concepts wasintervention. The patients felt limited bycreated, along with a storyline explaining

the medical technology available at thethe diagram．

time, which developed in them a feelingsimilar to resignation. It is possible that

Ethical Considerations

patients participate in clinical studies

This study was approved by the Kitasato

because their desired treatment is not

Institute Hospital Research Ethics

available through regular medical care.

Committee．

This could be deduced from another
patient, who stated “I would have not

Results

participated had I been able to receive

Participants

treatment to my satisfaction.”

Among participants of a clinical study on
immunoadsorption therapy for DCM, 12［Dissatisfaction with the medical care

who visited our hospital for follow-up

environment］

examination from April 2011 through May

Patients were dissatisfied with the medical

2012 were provided with an explanation

care environment around them, which notregarding the present study, and 11

only included medical staff but also

provided written consent to participate（9encompassed the entire medical caremen, 2 women; mean age ± SD＝52.7±9.2

system. One patientʼs narrative suggests

years）．

that they had negative feelings toward staff
members who did not provide the desired

Analysistreatment. Moreover, some patients showedParticipant narratives were recorded andthat they were dissatisfied with the current

direct transcript of the recording, whichstate of medical care as a whole. It is likely
7原著論文
Table 1

 oncepts that comprise the psychological processes experienced by patients with dilated cardiomyopathyC
who participated in a clinical study
clinical study

Firstcategory

Secondcategory

Third
category

Concept

Concept definition
From the early phase of treatment, patients (as one of many patients) compared themselveswith other patients.

PATIENT WHO
DIDN`T KNOW THE
CLINICAL STUDY

Sense of lack in medical technology
Feeling trapped

Appreciation
for the clinicalstudy

Dissatisfaction with the medical careenvironment

PsychologicalescapePatients felt that it was by sheer luck that they became aware of the new therapy and its
clinical study.

Hope for the desired environment

Patients anticipated a different environment with the new therapy, which included staff
members who perform the treatment that is more akin to what they desired.

Expectation for therapeutic value

Upon learning about the new therapy, patients came to anticipate positive results that might
be brought about in terms of their own disease treatment.

Concern for the unknowns

Patients were concerned about the fact that this is a clinical study, as well as aspects suchas the content of the treatment which they had never experienced before.

Desire to escape from the current
situation

Patients earnestly hoped for a change from the current situation in which they felt trapped
and unable to receive their desired treatment.

Recognition of the clinical study as
the only way to escapePatients regarded the clinical study as the only way that might allow for escape from thecurrent situation.
When making the decision regarding participation, patients experienced anxiety as they
predicted a desperate situation where, if participation was not possible, they would be backin their original situation.

Prediction of overwhelming
hopelessness

Decision toparticipate

Patients were hopeful about their prospects for escape from the current situation, wherenothing could be done.

Hope for escape

Hope arising from confirming
participation
PATIENT WHO
PARTICIPATED IN
THE CLINICALSTUDYExperience desired forthemselves

PATIENT WHOCOMPLETED THE
CLINICAL STUDY

Relief brought by confirming
participation

Once participation was confirmed, participants felt relieved to be released from the anxiety ofgoing back to the desperate situation.

Joy of successful escape fromhopelessness

Participants rejoiced in being able to escape from the helpless situation.

Moving to desirable environment

Patients felt that they received treatment of their choice from the staff and institution theyfound to be desirable.

Desirable therapeutic experience

Patients felt they received treatment of their choice.
After completing the clinical study, patients were satisfied with the fact that they were given a“treatment,” which was not possible when they were feeling trapped.

Satisfaction of “being treated”

Feeling of fulfillment

Setting a desirable future

Patients were dissatisfied with the medical staff and medical systems around them.

Accidental discovery

Hopefulness

PATIENT WHO
DISCOVERED THE
CLINICAL STUDY

Patients sensed the limitations of current medical technology and exhibited feelings similar toresignation.

Fulfillment found in therapeutic effects

Patients realized the therapeutic effects and felt satisfied.

Future of medical care environment

Patients pondered future medical care systems and the desirable state of medical care.

Patient’s own future

Patients considered their goals and hopes for their future life and treatment.

Compassion for those who did notparticipate in the study

Patients felt indebted to those who did not participate in the clinical study, and were thinkingof the feelings and the benefits for those patients.

PATIENT WHO COMPLETED THE CLINICAL STUDYPATIENT WHO DIDN`T KNOW THE CLINICAL STUDY

Compassion for those who did
not par�cipate in the study

Feeling trapped
Sense of lack of medical technology

Future of medicalcare environment
Setting a desirable future

Dissa�sfac�on with the medical care environment

Desire toescape fromthe current
environment

Appreciation for theclinical study

Accidental
discovery

Experience desired for themselves
Experiencing a desirable
environment
Desirable therapeu�cexperience

Psychological escape

Hopefulness
Hope for the desired
environment
Expecta�on fortherapeu�c value

Pa�ent’s own
futureRecogni�onas the only
way to escapePredic�on of
overwhelming
hopelessness

Hope arising from
conﬁrming participation
Reliefbrought by
conﬁrmingpar�cipa�on

Hope for escape

Joy ofsuccessful
escapeFeeling of fulﬁllment
Sa�sfac�on of “being
treated”
Fulﬁllment found intherapeu�c eﬀects

PATIENT WHO PARTICIPATED
IN THE CLINICAL STUDY

Decision to participate
Concerns about
the unknowns

Inﬂuencing rela�onships
Transi�oning rela�onships

PATIENT WHO DISCOVEREDTHE CLINICAL STUDY

Concept
Second and Third category
First Category

Figure 1 sychological processes experienced by patients with dilated cardiomyopathy who participated in aPclinical study8that negative images are not only createdtherapy, patients came to anticipate

due to “dissatisfaction with the medical

positive results that might be brought

environment,” such as medical staff andabout in terms of their own disease

medical care systems, but are also related

treatment. Patients had extremely highto thoughts about medical technology itself

expectations. Some patients even found（i.e., “sense of lack in medical technology”）．

hope in the fact that they had more options,in addition to the content of the clinical［Accidental discovery］

study itself. According to one patient, such

Patients felt that it was by sheer luck thatfeelings emerged while being fully aware ofthey found out about the new therapy or

the possibility that the therapy might notits clinical study. Although the majority ofnecessarily prove effective．

patients learned about the clinical study
through sources other than the medical［Concern for the unknowns］

staffs involved in their treatment, somePatients were concerned because the study

patients obtained the information directly

involved a treatment that lacked officialfrom the investigator of the study. In either

approval, and because the treatmentcase, patients were conscious of thecontent and components were such that

accidental nature, acknowledging that it isthey had not yet experienced. They were

well beyond their ability to even know

aware of the uncertainties of treatment

about therapies being studied．

effects and medical practice involved in theclinical study, and found these to be
somewhat worrisome．

［Hope for the desired environment］
Patients anticipated a different environm e n t（c o m p a r e d t o p r e v i o u s o n e s ）,［Desire to escape from the current

including staff members who would

situation］

administer treatments more in line with

Rather than hoping for therapeutic effects,

what they had hoped to receive. In thispatients hoped for a change from thecontext, the undesirable environment is thecurrent situation, in which they felt helplessone experienced prior to knowing about theand trapped．

clinical study. While the impact oftherapeutic effects was indeed significant,［Recognition of the clinical study as thepatients mentioned that they felt

only way to escape］

expectations for the different environment

Patients regarded the clinical study as theprior to study participation, suggesting that

only way that might enable them to escapethey were conscious about the newfrom their current situation. In reality,

environment regardless of therapeuticpatients may actually have other new ways

effects．

to proceed with their treatment may
outside of the clinical study, but patients［Expectation for therapeutic value］

viewed their discovery of the therapy

Upon learning about the experimental（closer to their desired treatment）as
9

原著論文

“sheer luck,” and thus perceived it as thetheir helpless situation, and exhibited aonly treatment available to them．

growing hope. It is likely that in cases
where the decision to participate was not［Prediction of overwhelming hopelessness］

spontaneous, patients may not have found

When making decisions about participation

this same hope．

in the clinical study, patients were anxious,
feeling that their inability to participate［Moving to a desirable environment］

would indicate a return to their original

Patients felt they were able to receive

environment. This is largely related to thetreatment from medical staff at thefact that clinical study participation is

institution of their choice. The uniqueperceived as the “only” way by whichclinical study environment with thepatients might escape from their actual

presence of a clinical research coordinatorsituation．

（CRC）,also seemed to be influential．

［Hope for escape］［Desirable therapeutic experience］

Patients were hopeful about the prospect ofPatients felt that they were able to receive

escaping from their current situation where

the treatment they chose for themselves,

they were unable to do anything about

through their participation in the clinicaltheir disease. While they realized thatstudy．

efficacy was not guaranteed, they had more
h o p e f o r t h e n e w t h e r a p y（ w h i c h w a s［Satisfaction of “being treated”］

closer to what they desired）relative to that

After completing the clinical study, patientsfor the current therapy, and decided towere satisfied with the fact that they wereparticipate．

given a “treatment,” which was not possible
when they were in a state where they felt

［Relief brought by confirming

trapped. In addition to the effects the study

participation］

had on their disease, patients found value inPatients felt relieved when their

the experience of participating in a clinicalparticipation was confirmed, as they felt

study, which is an experience the majority

released from the anxiety of returning theirof society will never have．

desperate situations. They were relieved to
not be stuck in a state characterized by a

［Fulfillment found in therapeutic effects］“feeling of overwhelming hopelessness.”

Patients realized the therapeutic effects

This feeling was predicted in the series ofand felt fulfilled. All patients who were

events, and patients reported a sense ofinterviewed in the present study felt somebeing saved．

effects. However, these therapeutic effects
did not necessarily correspond closely with

［Joy of successful escape fromnumerical values. For example, somehopelessness］

patients didnʼt feel enough therapeutic

Patients rejoiced when they escaped from

effects．
10

［Future of medical care environment］

from the same condition in the early stages

Patients pondered the optimal state ofafter diagnosis, and shared the feeling that

medical care based on their own experience

they were one of many patients with

with the clinical study, noting several

DCM．

aspects of the medical care environment

In general, patients had becomethat they hoped would be changed. One

somewhat resigned to accept the current

patient was conscious of benefits to otherstate of medical technology, which offeredpatients, while another patient was

no effective treatment. They wereconscious of his/her own treatment. Both offrustrated about this environment, whichthese cases were included in this concept ofincluded a system that did not allow thempatient consciousness about the medical

to receive the treatments they desired andcare environment as a whole, given that it

medical staff that could not perform suchis likely not possible to clearly separate

treatments. Under those circumstances,

between oneself and others．

they believed that they were not being
treated, and that to continue on this path

［Patientʼs own future］

would only lead to a decline in theirPatients had goals and hopes for theircondition, ending in a feeling that they had

future life and treatment. One patient waslost and were trapped. As such, they

thinking about his goals in terms of his

desired to escape from the current

work. In other cases, the medical procedureenvironment, with the hope of ending up in

itself was set as the goal, while others

a better situation．
In that context, the accidental

considered undergoing this treatment once

discovery of a new therapy and its clinicalagain as a specific hope．

study brought them hope as a new option.
［Compassion for those who did not

They were also hopeful and had positive

participate in the study］

feelings about the medical staff who could

Patients felt indebted to those who did not

perform the treatment they desired. At theparticipate in the study, and were wellsame time, however, they still worriedaware of their feelings as well as theabout the unknown, or other aspects ofpossible benefits of the clinical study for

medical care that they had not yetother patients. They perceived differences

experienced. Still, they appreciated the

between themselves and other patients, aschance to participate in a clinical study thatthey were the ones who received theallowed them to receive a test treatment

treatment．

for their intractable disease, versus theircurrent state of continuous decline andStoryline

feeling of being trapped．

Patients who participated in a clinical study

This appreciation was combined withfor DCM, an intractable disease, faced their

their original desire to escape. They viewed

disease thinking that they were similar tothe clinical study as the only means ofother patients with DCM who sufferedescape, and felt fortunate to have
11

原著論文

discovered it. They decided to participate

patients perceived themselves as one ofin the clinical study, thinking that it was

many patients who had the same disease.

the only way to change their current

They then perceived themselves as thosesituation. At that point, amidst the hope for

who were able to discover the clinicalescape, they felt a great deal of appre-

study by chance, and after participating

hension, imagining the despair of fallingand going through the study without any

again into a helpless situation if they wereincident, they perceived themselves as

to lose this only option. Psychologically,

those who participated in a clinical study．

they were not in the state of helplessness

On that basis, patients were conscious,that made them feel trapped, but rather in

not only of themselves, but other patientsa condition where they managed towith the same disease and their desired

mentally escape from the impasse, andimage of future medical environments assome direction toward the means, i.e., thewell．

clinical study, could be seen．

Discussion

The anxiety they felt at the time ofdecision-making disappeared when their

In this study, we conducted an interview

participation was confirmed. At this time,survey targeting patients who participatedthey felt joy at being released from thein an investigator-initiated clinical study on

previous state of deadlock, in which theyimmunoadsorption therapy for DCM.

harbored many unsatisfied feelings. Feeling

Participants had DCM, a disease with aof hope arose from the confirmation of theirpoor prognosis, usually treated withparticipation in the clinical study．

standard therapy mainly consisting of

After that, they received the treatment

symptomatic treatment for heart failure

they chose for themselves in the context ofand prevention of further disease

the clinical study, and through interactions

progression１）. While previous studies havewith medical staff involved in the process,shown that process of decision-making

they believed that they were able to assess

concerning participation in a clinicalwhat is desirable in the state of medicals t u d y ６，８ ） a s w e l l a s e x p e r i e n c ecare．

participating in a clinical study７，11）have

After completing the clinical study,

various effects on participantsʼ psychology,

patients felt satisfaction in knowing thatthe present study was novel to theorize

their desired “treatment” was performed in

psychological processes in DCM patientsthe end, felt fulfilled with the therapeutic

from the time before participation in theintervention as well as the very fact thatclinical study through its completion．

they were able to place themselves in such

Participation in a clinical study may

an environment. They had a sense of well-have become a means to receive

being．

“treatment” for patients with intractable

When considering the major categories,

diseases, for whom standard therapy is notpatient perception changed over the course

effective or for whom there are noof the study; after receiving a diagnosis,

prospects of achieving full recovery with12

standard therapy 12）. Surveys targeting（i.e., those for whom this anxiety waspatients with cancer who participated in arealized）should be taken into consideration

phase I clinical study have shown thatwhen recruiting clinical study subjects．

some patients had “expectations for

As shown in the Figure1, the transition

investigative treatment” 13，14）or hoped “tofrom being “patient who didnʼt know theget better” 14）, which served as decision-clinical study” to “patient who discovered

making factors regarding clinical study

the clinical study” was triggered by anparticipation. Moreover, some patients who“accidental discovery,” and ourparticipated in a clinical study on heart

participants perceived this transition to bedisease had an “expectation of bettervery challenging. They also recognized thet r e a t m e n t ” 1 5 ）. W e p r e d i c t e d t h a t t h eclinical study that they found throughparticipants of the present study would also

sheer luck as “the only way.” This suggests

have similar expectations from the clinicalthat patients have tremendous anxiety, i.e.,

study regarding therapeutic effects 16-19）.

“a sense of overwhelming hopelessness”

Participants analyzed in this study had

about having to return to their originalenormous anxiety（predicted as a sense ofstate. Currently, information regarding

overwhelming hopelessness）from the timetherapies and clinical studies can beof decision-making regarding participation

obtained on the Internet, if patients actively

in the clinical study until official

seek to collect it. However, this is still

confirmation of their participation. Patients

somewhat insufficient under present

with DCM experience a lower QOL

circumstances in Japan21）. In fact, patientscompared to the general population and areare aware of the difficulty of discovering

often more anxious and depressive20）. Thus,

clinical studies, and thus there is room forthese patients are more prone to suffer

improving methods of accessing clinicalfrom both physical and psychological pain.

study information. It may be necessary for

In addition to their daily physical andmedical staff to be more proactive about

psychological burden, patients who

providing information to patients on new

anticipate an escape from the pain oftherapies and clinical studies. Japanesedisease by undergoing an experimental

Ministries have initiated a “5 yearly clinicaltreatment（clinical study）are placed instudy activation plan 2012” from 2012,

uncertain situations, such as not knowing“Ethical guidelines on medical research forabout their participation, which only

human subjects” from 2014 and “Clinicalincreases the anxiety. Such levels of

Trial Act” from2018, and they are trying to

uncertainty may also exist among patients

promote clinical study publically andwho could not participate in the clinicalencourage participation from the general

study, but as these patients were notpublic22-24）．

included in the present survey, we couldnʼt

Several limitations of the present study

extrapolate on their thoughts. The

should be noted. The present study only

damaging effects on patients who were

included interviews performed at the time

unable to participate in the clinical studyof clinical study completion, and thus
13

原著論文

patients had positive images concerning the

The findings of this study reveal an

study content. As such, interviews with

importance in the capacity for medical

patients who had negative views regarding

staffs to interact with patients at the level

the study, or those who could notof general medical care by taking into

participate in the clinical study, were notaccount the patientʼs attitude, even if they

included in the collected data. This may

are unable to provide patients with a newhave biased the results. Moreover, only

therapy on the spot. Furthermore, it will

limited number of participants werealso be necessary to consider the burden on

recruited for this study because thestaff who respond to the expectations of

number of clinical research volunteers werethese patients. This study may belimited. Future studies should take theinformative the importance to understandpresent study results into account andthe psychological statement of theallow for the inclusion of such patients．

intractable disease patients．

Conclusion

List of abbreviations

Our study showed that patients have highDCM; Dilated cardiomyopathy

expectations regarding clinical study

NYHA; the New York Heart Association

participation, not only for the treatment it

CRC; clinical research coordinator

offers but also with respect to medical staff
involved in the study who perform the

Declarations

desire treatment. Moreover, we found that

Ethics approval and consent to participate,patients are highly aware of the medical

consent to publish

environment that surrounds them,This study was approved by the Kitasato

including systems pertaining to medical

Institute Hospital Research Ethics

care as well as medical staff. This

Committee．

awareness is cultivated by their

Participants were given an explanation

experiences from the time before they

regarding the present study, and provided

learned about the clinical study throughwritten consent to participate in this study.

completion of the study. In particular, they

Our data doesnʼt report on individual

were keenly aware of the difference

patient data．

between the previous environment inwhich they received no satisfactory

Availability of data and materials

therapies and the environment they placed

The datasets used and/or analyzed during

themselves in through the experience of athe current study are available from theclinical study. Hence, in regard tocorresponding author on reasonable

treatment after the clinical study, they

request．

hoped to be in an environment where theywould be able to interact with their desiredCompeting interests

medical staff, even if they could not receive

There is no conflict of interests in thisthe new therapy．

study．
14

Funding

Wakabayashi Y, Takahashi M et al. Complete

No funding was received．

elimination of cardiodepressant IgG3
autoantibodies by immunoadsorption inpatients with severe heart failure. Circ J.

Authorsʼ contributions

2010；74（7）：1372-8．

YI and NT designed the study protocol,

３．Dandel M, Wallukat G, Englert A, Hetzer R.

monitored data collection for the whole

Immunoadsorption therapy for dilated

trial, analyzed the data, and drafted andcardiomyopathy and pulmonary arterial
hypertension. Atheroscler Suppl. 2013；14

revised the paper. EA initiated the（1）：203-11. doi:10.1016/j.atherosclerosissup.

collaborative project, designed the study

2012.10.029．

protocol, monitored data collection,

４．Gho JM, Kummeling GJ, Koudstaal S, Jansen

analyzed the data, and drafted and revised

Of Lorkeers SJ, Doevendans PA, Asselbergs

the paper. AB designed the study protocol,

FW et al. Cell therapy, a novel remedy formonitored data collection for the wholedilated cardiomyopathy? A systematic review.

trial, and revised the draft paper．

J Card Fail. 2013；19（7）：494-502. doi: 10.
1016/j.cardfail. 2013.05.006．
５．Developmental Promtion Committee ofAuthorsʼ information

Japan Human Sciences Foundation.

EA is an associate professor and a Ph.D. in

Perspective for medical-care needs in 2020. In:

Clinical Pharmacy. YI has Bachelor ofJapan Health Sciences Foundation. Tokyo.

Pharmacy degree（a six-year course）and

2011. pp. 144

is a pharmacist. NT is a Ph.D. in Medicine.

６．Kohara I, Inoue T. Searching for a way to

A B（ M D , P h . D . ）i s a c a r d i o v a s c u l a r

live to the end: decision-making process in

specialist．

patients considering participation in cancer

Acknowledgements

2010 ; 37（2）:E124-32．

phase I clinical studies. Oncol Nurs Forum.
doi:10.1188/10.ONF.

E124-Ｅ132．

The authors wish to acknowledge the７．Kelly C, Ghazi F, Caldwell K. Psychologicalcontributions of all study participants．

distress of cancer and clinical study
participation: a review of the literature. Eur J

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