10.4081/btvb.2023.59
Clinical research is vital in supporting evidence-based practice. However, several barriers make participation in research difficult. We performed a survey to evaluate the attitude to research of the members of the Italian Anticoagulation Clinics. The survey includes 19 closed questions on the perception of participating in research and exploring the benefit that health professionals wish to obtain. A total of 167 questionnaires were returned from 97/220 (44.1%) Centers, of which 89.7% were not academic. Participants (median age 56 years, range 29-75y; 56.3% females) were equally distributed all over the country; 151/167 (90.4%) of respondents believe that participating in research helps to reduce the routine of their work and allows a better quality of work, 72/167 (43.1%) complain heavy workload. More than 74% of respondents would like to participate in scientific meetings, without difference in relation to age. Instead, inclusion in the authorship of a scientific paper is of relevance for 75.6% of respondents ≤50 years and for 65.2% of respondents &gt;50 years. A substantial positive attitude towards research was evident, suggesting that independent scientific societies could be of valuable support for the growth of research culture.
application/pdf
2785-5309
59
1
en
Alessandro Squizzato
https://creativecommons.org/licenses/by-nc/4.0
Bleeding, Thrombosis and Vascular Biology
Research
Attitude to clinical research among health professionals affiliated with the Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the Surveillance of the Antithrombotic Therapies (FCSA)
Text.Serial.Journal
https://www.btvb.org/btvb
2
Original Articles
2023-03-21
2022-11-09
2023-01-27
2023-03-21
Bleed Thromb Vascul Biol
Alessandro Squizzato
2023/03/21
10.4081/btvb.2023.59
Research Center on Thromboembolic Disorders and Antithrombotic Therapies, University of Insubria, Como; Internal Medicine Unit, Sant’Anna Hospital, ASST Lariana, San Fermo della Battaglia
2785-5309
1
Research
en
Russo PS, T.; Romano, F. . Il valore della spesa sanitaria in Italia dal 1990 al 2016. GIHTAD. 2019;12:1-6.
Attitude to clinical research among health professionals affiliated with the Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the Surveillance of the Antithrombotic Therapies (FCSA)
https://www.btvb.org/btvb/article/download/59/61
2
                                                                                                            ORIGINAL ARTICLE

Attitude to clinical research among health professionals affiliated with the
Italian Federation of Centers for the Diagnosis of Thrombotic Disorders and the
Surveillance of the Antithrombotic Therapies (FCSA)
                                                                             Daniela Poli,1 Riccardo Tartaglia,2 Doris Barcellona,3
                                                                             Paolo Bucciarelli,4 Antonio Ciampa,5
 Correspondence: Daniela Poli, Thrombosis Center, Azienda Os-                Elvira Grandone,6,7 Giuseppe Malcangi,8
 pedaliero-Universitaria Careggi, Florence, Italy.                           Giuseppe Rescigno,9 Vincenzo Toschi,10 Sophie Testa,11
 Tel.: +39.0557945453.
 E-mail: polida@aou-careggi.toscana.it
                                                                             Alessandro Squizzato12,13

 Citation: Poli D, Tartaglia R, Barcellona D, et al. Attitude to clinical
                                                                             1
                                                                              Thrombosis Center, Careggi Hospital, Florence, Italy;
 research among health professionals affiliated with the Italian Fed-        2
                                                                              Marconi University Department of Engineering, Bologna,
 eration of Centers for the Diagnosis of Thrombotic Disorders and            Italy; 3Thrombosis and Haemostasis Unit, University of
 the Surveillance of the Antithrombotic Therapies. Bleeding,                 Cagliari, Cagliari, Italy; 4Angelo Bianchi Bonomi Hemophilia
 Thrombosis, and Vascular Biology 2023;2:59.                                 and Thrombosis Center, Fondazione IRCCS Ca’ Granda,
                                                                             Ospedale Maggiore Policlinico, Milan, Italy; 5Haemostasis
 Key words: Anticoagulation; Research.
                                                                             Center, AORN S.G. Moscati, Avellino, Italy; 6Thrombosis and




                                                                                               ly
 Contributions: DP, RT, conceived the conceptual design of the               Haemostasis Unit, IRCCS. Casa Sollievo della Sofferenza,
 study; DP, AS, per-formed data interpretation; DP, wrote and re-            San Giovanni Rotondo, Italy; 7Ob/Gyn Department of The




                                                                                       on
 vised the manuscript; DP, AS, performed data interpretation and             First I.M. Sechenov Moscow State Medical University,
 revised the manuscript. All the authors approved the final version          Moscow, Russia; 8Haemophilia and Thrombosis Center, AOU
 to be published.                                                            Policlinico, Bari, Italy; 9Haemostasis and Thrombosis Center,




                                                                                 e
                                                                             DEA P.O. “Umberto I”, Nocera Inferiore, Salerno, Italy;
 Conflict of interest: Poli D: honoraria for lectures and manuscript
 writing from Daiichi Sankyo, Boheringer Ingelhein, Bristol-Myers
 Squibb, Pfizer, Viatris, Leo Pharma, Alfasigma. Barcellona D: hon-
 oraria for lectures from Aspen and Werfen. Ciampa A: honoraria
                                                                            us
                                                                             10
                                                                                Department of Haematology and Blood Transfusion and
                                                                             Thrombosis Center, Santi Paolo e Carlo Hospital, Milan, Italy;
                                                                             11
                                                                                Haemostasis and Thrombosis Center, ASST Cremona,
                                                                            al
 for lectures from Bayer. Grandone E: honoraria for lectures from            Cremona, Italy; 12Research Center on Thromboembolic
 Sanofi and Italfarmaco, and for advisory board from Roche, Sanofi           Disorders and Antithrombotic Therapies, University of
                                                        ci

 Genzyme, and NovoNordisk. Malcangi G: advisor board Bayer.                  Insubria, Como, Italy; 13Internal Medicine Unit, Sant’Anna
 Toschi V: honoraria for lectures from Bayer and NovoNordisk.                Hospital, ASST Lariana, San Fermo della Battaglia, Italy
                                                      er


 Testa S: honoraria for lectures and for participation on advisory
 board from Werfen, Stago, Daiichi Sankyo, Alexion, Italfarmaco,
                                                     m



 Pfizer, Bristol-Myers Squibb, Sanofi. Squizzato A: honoraria for
 lectures, manuscript writing and/or advisory board from Daiichi
                                          om




 Sankyo, Bayer, Pfizer, Bristol-Myers Squibb, Sanofi, Werfen,                ABSTRACT
 Alexion, Roche, Viatris. The other Authors declare no potential                  Clinical research is vital in supporting evidence-based
 conflict of interest.                                                       practice. However, several barriers make participation in re-
                                   -c




                                                                             search difficult. We performed a survey to evaluate the attitude
 Funding: None.                                                              to research of the members of the Italian Anticoagulation Clin-
                          on




                                                                             ics. The survey includes 19 closed questions on the perception
 Availability of data and material: Data and materials are available
                                                                             of participating in research and exploring the benefit that
 by the Authors.
                                                                             health professionals wish to obtain. A total of 167 question-
                    N




 Informed consent: The manuscript does not contain any individual            naires were returned from 97/220 (44.1%) Centers, of which
 person’s data in any form.                                                  89.7% were not academic. Participants (median age 56 years,
                                                                             range 29-75y; 56.3% females) were equally distributed all over
 Received for publication: 6 February 2023.                                  the country; 151/167 (90.4%) of respondents believe that par-
 Accepted for publication: 14 February 2023.                                 ticipating in research helps to reduce the routine of their work
                                                                             and allows a better quality of work, 72/167 (43.1%) complain
 Publisher’s note: All claims expressed in this article are solely those
                                                                             heavy workload. More than 74% of respondents would like to
 of the authors and do not necessarily represent those of their affili-
                                                                             participate in scientific meetings, without difference in relation
 ated organizations, or those of the publisher, the editors and the re-
 viewers. Any product that may be evaluated in this article or claim
                                                                             to age. Instead, inclusion in the authorship of a scientific paper
 that may be made by its manufacturer is not guaranteed or endorsed          is of relevance for 75.6% of respondents ≤50 years and for
 by the publisher.                                                           65.2% of respondents >50 years. A substantial positive attitude
                                                                             towards research was evident, suggesting that independent sci-
 ©
  Copyright: the Author(s), 2023                                             entific societies could be of valuable support for the growth of
 Licensee PAGEPress, Italy                                                   research culture.
 Bleeding, Thrombosis and Vascular Biology 2023; 2:59
 doi:10.4081/btvb.2023.59

 This work is licensed under a Creative Commons Attribution-
 NonCommercial 4.0 International License (CC BY-NC 4.0).



                                              Bleeding, Thrombosis and Vascular Biology 2023; 2:59
32                                                        D. Poli et al.




                                                                     ity of anticoagulation of patients treated with VKAs. All
INTRODUCTION                                                         affiliated Centers are invited to participate in the program.
     Clinical research is vital in providing optimal patient         A periodic report of the laboratory and clinical results is
care and can lead to the development of better treatments            sent to all the participants. Participation in laboratory ex-
through evidence-based practice.1 Moreover, it has been              ercises is mandatory for affiliated Centers, whereas par-
shown to impact on processes and policy of healthcare                ticipation in the clinical quality program is only
services,2,3 positively influencing the clinical practice and        recommended.
the development of new treatments.4                                      In order to evaluate the attitude to the research of the
     Despite such benefits, several barriers have been iden-         members of FCSA, we performed a survey among all the
tified amongst health professionals, who complain that               healthcare professionals affiliated with FCSA.
lack of time, training, knowledge, and funding may pre-
vent them from participating in research. Moreover, the
fear that research activities may interfere with clinical            MATERIALS AND METHODS
care, thus reducing efficiency and productivity, has been                 The survey was available on a dedicated online form
reported.5 A recent systematic review reported that the de-          guaranteeing anonymity. An e-mail invitation to answer
velopment of a stronger research culture appears to be as-




                                                                                             ly
                                                                     was sent to all 220 FCSA Centers and to 50 individual
sociated with benefits to patients, staff and organizations.5        healthcare professionals affiliated with FCSA in February




                                                                                      on
All the studies analyzed in this systematic review reported          2022, followed by two reminders in the subsequent
a positive association between research activities and or-           weeks.
ganizational performance of healthcare services, including                The survey included 19 closed questions and was de-



                                                                                 e
lower patient mortality rates and higher levels of patient           veloped into three main sections: the first explored gen-
satisfaction. In addition, when the analysis was conducted
among healthcare professionals, reduced staff turnover,
                                                                           us
                                                                     eral information about the respondents (affiliation, age,
                                                                     experience in participating in research studies and partic-
improved staff satisfaction, and improved organizational
                                                                   al
                                                                     ipation in FCSA clinical and laboratory yearly exercises);
efficiency were found.5 In addition, it has been high-               the second was focused on the respondents’ perception
                                                      ci

lighted that the adequate translation of high-quality re-            about participating in research activities; the third was fo-
search in clinical practice may lead to an improvement of
                                                    er


                                                                     cused on knowing the benefit that health professionals
health care and that the presence of a strong research cul-          wish to obtain in participating in research activities. Ten
                                                   m



ture may facilitate this process and provide benefits for            of the questions concerning attitude, perception, practice,
health systems.6                                                     and barriers towards medical research were assessed using
                                          om




     Notwithstanding this evidence, the Italian National             a Likert scale, ranging from 1 to 5 (1 = strongly disagree;
Health System does not organize specific programs to ed-
                                                                     2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5
ucate and promote clinical research among healthcare pro-
                                     -c




                                                                     = strongly agree).
fessionals. Despite these difficulties, since its foundation
                                                                          The results were analyzed using only descriptive sta-
in 1989, the Italian Federation of Centers for the Diagno-
                             on




                                                                     tistics: categorical data were reported as counts and per-
sis of Thrombotic Disorders and the Surveillance of the
                                                                     centages.
Antithrombotic Therapies (FCSA) promoted and per-
                         N




formed many collaborative studies, all of which con-
ducted as spontaneous research without the support of
                                                                     RESULTS
public or private funding.7-13 Several other studies have
been performed by Centers (i.e. Anticoagulation Clinics)                 A total of 167 filled questionnaires were returned, 144
affiliated with FCSA, as monocentric studies or more re-             (86.2%) from Centers and 23 (13.8%) from individual
stricted collaborative studies on specific laboratory and            healthcare professionals. In particular, the 144 question-
clinical aspects concerning the management of anticoag-              naires from Centers were filled by respondents working
ulation, and several FCSA Centers actively participate in            in 97 (44.1%) out of the 220 federated Centers, and 87
patients enrollment of the ongoing Italian START Regis-              out of these 97 (89.7%) Centers do not belong to aca-
ter,14 one of the biggest registry on anticoagulation therapy        demic Institutions (see Table 1 for details). The median
worldwide.                                                           age of the participants was 56 years (range 29-75 years),
     FCSA includes 220 affiliated Anticoagulation Clinics,           45 (26.9%) of them were aged less than 50 years and 94
distributed all over the Country, and following up to                (56.3%) were females. One hundred and thirty-seven
300,000 patients on treatment with vitamin K antagonists             (82.0%) were physicians, and 30 (18.0%) were biologists.
(VKAs). FCSA organizes a specifically designed labora-                   Participants were distributed in 17 (81.0%) of the 21
tory external quality control program, which runs three              Italian regions: 65 (38.9%) in the North, 33 (19.8%) in
times yearly, and the yearly collection of data on the qual-         the Centre, and 42 (25.1%) in the South.

                                     Bleeding, Thrombosis and Vascular Biology 2023; 2:59
                                               Clinical research among the members of the FCSA                                     33



    Of the 167 respondents, 132 (79.0%) regularly partic-
ipate in the laboratory external quality program, and 109                 DISCUSSION
(65.3%) regularly participate in the clinical surveillance                    The results of this national survey conducted among
exercise. The great majority of participants (142/167,                    physicians and biologists working in the Centers affiliated
85.0%) have experience in previous research studies,                      with the FCSA and individual health professionals - ex-
whereas 41.3% of them were involved in only one study.                    perts in the management of patients with thrombotic dis-
    The majority of respondents (151/167, 90.4%) believe                  ease and of anticoagulated patients - associated with the
that participating in clinical research helps professionals               FCSA, indicate a widespread positive feeling toward the
to reduce the usual routine of their work and allow a better              participation to research during their routine practice. In-
quality of the work (148/167, 88.6%), even if 72/167                      deed, the response rate to this survey was 44.1%, higher
(43.1%) of the participants complain that it requires heavy               than other published papers using online surveys (median
workload. The percentage of respondents who complains                     response rate was around 26.0%).15-17
of worsening workload is reduced among participants                           Interestingly, from the first ISCOAT study to the last
younger than 50 years (37.8%) in comparison to partici-                   PLECTRUM study,7,13 the participation in the collabora-
pants older than 50 years (45.5%).                                        tive FCSA studies was quite stable over time, including
    Seventy-five out of 167 (44.9%) of all participants an-               30 Centers on average (from 22 to 34). In addition, 59




                                                                                           ly
swered that their institution encourages research partici-                FCSA Centers are actively participating in patients’ en-




                                                                                    on
pation, in particular among individual healthcare                         rollment of the Italian START Register,14 an Italian reg-
professionals (61.9%). One hundred and sixteen respon-                    istry on oral anticoagulated patients. These results seem
dents (69.4%) were confident of having adequate profes-                   of particular interest taking into account the low publica-




                                                                               e
sional skills to participate in research studies, without any             tion rate of Italian academic and non-academic healthcare
difference according to age.
    Seventy-seven of respondents (46.1%) dedicate more
                                                                        usprofessionals.18
                                                                              The attitude of healthcare professionals affiliated with
than 3 hours per month to research activities, 62 (37.1%)                 FCSA seems to be stable over time, irrespective of age
                                                                     al
2-3 hours per month, and 28 (16.8%) 1 hour per month.                     and different working conditions due to the progressive
                                                     ci

    More than 74% of respondents would like to partici-                   reduction of economic resources provided by the National
pate in national or international scientific meetings, with-              Health Service. In particular, in our country, the annual
                                                   er


out any difference according to age. Conversely, inclusion                health expenditure was estimated to be 7% of the domes-
in the authorship of a scientific paper is important for
                                                  m



                                                                          tic product in 2001 and 6.6% in 2019, with annual spend-
75.6% of respondents younger than 50 years and for                        ing per capita that remains stable in the last ten years.19
                                       om




65.2% of respondents older than 50 years. Similarly, ap-                  To obtain a reduction in health expenditure, a strong re-
preciation by colleagues is more relevant for younger re-                 duction in the number of healthcare professionals has
spondents (82.2%) than among the elderly (69.4%).                         been made. The number of physicians has been reduced,
                                 -c




                                                                          and the median age of healthcare professionals is progres-
                                                                          sively increased.
                         on




                                                                              Despite these difficulties, why do healthcare profes-
                                                                          sionals affiliated with FCSA show a similar favorable at-
                   N




Table 1. Characteristics of respondents.                                  titude in participating in research? A possible explanation
Respondents                                                167            may be the feeling of being part of a successful scientific
                                                                          program with significant study results on daily clinically
Working in a Center, N (%)                              144 (86.2)
                                                                          relevant questions concerning anticoagulation manage-
Individual healthcare professionals, N (%)              23 (13.8)
                                                                          ment. The perception of being a member of a scientific
Respondent FCSA Centers, N (%)*                         97 (44.1)
                                                                          community may constitute a reason for satisfaction for
Females, N (%)                                          94 (56.3)         healthcare professionals, independently by a clear eco-
Median age, years (range)                              56 (29-75)         nomic benefit or career advance. FCSA is indeed an in-
Age <50 years, N (%)                                    45 (26.9)         dependent organization that seems to provide healthcare
Physician, N (%)                                        137 (82.0)        professionals with the desire to be more involved in re-
Biologist, N (%)                                        30 (18.0)         search and the motivation to make extra efforts not di-
Geographical distribution (%)                                             rectly required by their institutions.
 North                                                  65 (38.9)             Moreover, FCSA actively promotes a research culture,
 Centre                                                 33 (19.8)
                                                                          inviting affiliated professionals to participate in clinical
 South                                                  42 (25.1)
                                                                          research, and promoting an extensive educational pro-
FCSA, Italian Federation of Centers for the Diagnosis of Thrombotic
Disorders and the Surveillance of the Antithrombotic Therapies.           gram that reinforces the sense of belonging. In fact, FCSA
*Calculated on a total of 220 FCSA Centers.                               regularly plans teaching courses, an annual national sci-

                                             Bleeding, Thrombosis and Vascular Biology 2023; 2:59
34                                                            D. Poli et al.




entific Congress, and the publication of a yearly updated                      ticipation in clinical research and trials: issues and ap-
practical guide for the management of antithrombotic                           proaches. Adv Med Educ Pract 2011;2:85-93.
therapies. Moreover, a mobile app has been recently de-                   5.   Harding K, Lynch L, Porter J, et al. Organisational benefits
veloped to ensure rapid interaction among health profes-                       of a strong research culture in a health service: a systematic
sionals and to discuss practical daily clinical problems.                      review. Aust Health Rev 2017;41:45-53.
    This study has several limitations. First, research atti-             6.   Skinner EH, Williams CM, Haines TP. Embedding research
                                                                               culture and productivity in hospital physiotherapy depart-
tude was investigated by a self-reported questionnaire,
                                                                               ments: challenges and opportunities. Aust Health Rev
and it is possible that respondents have been influenced
                                                                               2015;39:312-4.
by the mainstream opinion on FCSA instead to report their
                                                                          7.   Palareti G, Leali N, Coccheri S, et al. Bleeding complica-
true feeling. However, the questionnaire was completely                        tions of oral anticoagulant treatment: an inception- cohort,
anonymous: therefore, a free personal opinion should be                        prospective collaborative study (ISCOAT). Italian Study on
presumed. Second, the number of questions was limited,                         Complications of Oral Anticoagulant Therapy. Lancet
and no information is available on the role of the single                      1996;348:423-8.
healthcare professional in the hierarchical health services               8.   Palareti G, Legnani C, Guazzaloca G, et al. Risks factors for
organization. In particular, the answers to the questions                      highly unstable response to oral anticoagulation: a case-con-
concerning the role of the institutions in promoting re-                       trol study. Br J Haematol 2005;129:72-8.




                                                                                                      ly
search could have been influenced by the role of the re-                  9.   Pengo V, Cucchini U, Denas G, et al. Standardized low-mol-




                                                                                              on
spondent. Finally, non-respondents did not provide any                         ecular-weight heparin bridging regimen in outpatients on
explanation for their refusal to participate in the survey.                    oral anticoagulants undergoing invasive procedure or sur-
It should be noted that the majority of non-respondents                        gery: an inception cohort management study. Circulation




                                                                                        e
were from Centers that did not participate in collaborative                    2009;119:2920-7.
studies, whereas 85% of respondents had previous expe-
rience of active participation in research, even if in 41.3%
                                                                         10.
                                                                                us
                                                                               Poli D, Antonucci E, Testa S, et al. Bleeding risk in very old
                                                                               patients on vitamin K antagonist treatment: results of a
                                                                               prospective collaborative study on elderly patients followed
of cases only in one occasion.
                                                                       al
                                                                               by Italian Centres for Anticoagulation. Circulation
                                                                               2011;124:824-9.
                                                         ci

                                                                         11.   Poli D, Antonucci E, Dentali F, et al. Recurrence of ICH
CONCLUSIONS
                                                       er


                                                                               after resumption of anticoagulation with VK antagonists:
     In conclusion, this survey presented an analysis of the                   CHIRONE study. Neurology 2014;82:1020-6.
                                                      m




levels of research awareness and attitudes toward research               12.   Tosetto A, Manotti C, Marongiu F, et al. Center-Related De-
among health professionals affiliated with the independ-                       terminants of VKA Anticoagulation Quality: A Prospective,
                                             om




ent scientific society FCSA. A substantial positive attitude                   Multicenter Evaluation. PLoS One 2015;10:e0144314.
towards research was evident and consistent across the                   13.   Poli D, Antonucci E, Pengo V, et al. Mechanical prosthetic
                                                                               heart valves: Quality of anticoagulation and thromboem-
                                       -c




age and professional groups. Participation in research is
                                                                               bolic risk. The observational multicenter PLECTRUM
fundamental to the implementation of evidence-based
                               on




                                                                               study. Int J Cardiol 2018;267:68-73.
medicine and ensuring high-quality patient care. Active
                                                                         14.   Antonucci E, Poli D, Tosetto A, et al. The Italian START-
programs for a culture of research should be implemented                       Register on Anticoagulation with Focus on Atrial Fibrilla-
                          N




by the National Health Services and independent scien-                         tion. PLoS One 2015;10:e0124719.
tific societies could be of valuable support for the growth              15.   Chokshi NK, Simeone DM, Chari RS, et al. A survey of ac-
of research culture.                                                           ademic surgeons: work, stress, and research. Surgery
                                                                               2009;146:462-8.
                                                                         16.   Paget SP, Lilischkis KJ, Morrow AM, et al. Embedding re-
                                                                               search in clinical practice: differences in attitudes to research
REFERENCES                                                                     participation among clinicians in a tertiary teaching hospital.
                                                                               Intern Med J 2014;44:86-9.
 1. Johnson C, Lizama C, Harrison M, et al. Cancer health pro-
                                                                         17.   Caldwell B, Coltart K, Hutchison C, et al. Research aware-
    fessionals need funding, time, research knowledge and skills
    to be involved in health services research. J Cancer Educ                  ness, attitudes and barriers among clinical staff in a regional
    2014;29:389-94.                                                            cancer centre. Part 1: a quantitative analysis. Eur J Cancer
 2. Mant D, Del Mar C, Glasziou P, et al. The state of primary-                Care (Engl) 2017;26.
    care research. Lancet 2004;364:1004-6.                               18.   Sistema di valutazione della performance dei sistemi sanitari
 3. Kalucy EC, Jackson-Bowers E, McIntyre E, et al. The fea-                   regionali Available from: https://www.santannapisa.it/it
    sibility of determining the impact of primary health care re-              erza-missione/sistema-di-valutazione-della-performance-
    search projects using the Payback Framework. Health Res                    dei-sistemi-sanitari-regionali
    Policy Syst 2009;7:11.                                               19.   Russo P, Staniscia T, Romano, F. Il valore della spesa sani-
 4. Rahman S, Majumder MA, Shaban SF, et al. Physician par-                    taria in Italia dal 1990 al 2016. GIHTAD 2019;12:1-6.


                                        Bleeding, Thrombosis and Vascular Biology 2023; 2:59
