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Shared decision making in Italy: An updated revision of the current situation
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Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) journal homepage: http://www.elsevier.com/locate/zefq
Shared decision making in Italy: An updated revision of the current situation Partizipative Entscheidungsfindung in Italien: die aktuelle Situation im Überblick Alessandro Bottacini 1,∗ , Peter Scalia 2 , Claudia Goss 1 1 2
Department of Neurosciences, Biomedicine and Movement Sciences, Section of Clinical Psychology, University of Verona, Verona, Italy The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, 1 Medical Center Drive, Lebanon, USA
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Keywords: shared decision making public health patient participation Italy
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Schlüsselwörter: partizipative Entscheidungsfindung Public Health Patientenbeteiligung Italien
a b s t r a c t The aim of this paper is to update the previous review on the state of patient and public participation in healthcare in Italy. Policymakers consider patient involvement an important aspect in health care decisions and encourage patients to actively participate in the clinical interaction. Nevertheless, the term shared decision making (SDM) is still not clearly defined. Patient associations promote patient participation in health care decisions. Several experts attended the latest consensus conference about patient engagement to reach a consensus on the definition of SDM. Research regarding SDM in Italy continues to increase with 17 articles published between 2012 and 2017. Researchers have assessed the variables associated with patient involvement and explored the use of the SDM approach in different medical settings. Despite the dedicated SDM initiative, researchers in Italy recognize room for improvement. Work is needed to reach a common language regarding SDM and its mechanisms to implement this approach at the clinical level.
z u s a m m e n f a s s u n g Der vorliegende Beitrag stellt die Aktualisierung eines früheren Reviews zum Stand der Partizipation von Patienten und der Öffentlichkeit am italienischen Gesundheitswesen dar. Politische Entscheidungsträger sehen die aktive Beteiligung von Patienten an gesundheitsbezogenen Entscheidungen als wichtig an, auch wenn der Begriff ‘‘partizipative Entscheidungsfindung‘‘ (PEF), so wie er uns geläufig ist, noch nicht ausdrücklich erwähnt oder beschrieben worden ist. Von den Patientenverbänden wird die Partizipation der Patienten und Bürger an gesundheitsbezogenen Entscheidungen aktiv gefördert. Mehrere Experten nahmen an der letzten Konsensuskonferenz zur Patientenbeteiligung teil, um zu einer gemeinsamen Definition von PEF zu gelangen. Die Forschungstätigkeit zum Thema PEF hat in Italien zugenommen. So wurden von 2012 bis 2017 17 Beiträge publiziert, in denen verschiedene mit Patiententeilhabe verbundene Parameter sowie der Einsatz von PEF in unterschiedlichen medizinischen Bereichen untersucht wurden. Trotz der Initiative zur Förderung von PEF sehen Wissenschaftler in Italien noch Raum für Verbesserungen. So sollten weitere Anstrengungen unternommen werden, um zu einem einheitlichen Verständnis bezüglich PEF und der Mechanismen zu gelangen, mit deren Hilfe PEF im klinischen Bereich implementiert werden kann.
Introduction ∗ Corresponding author: Alessandro Bottacini, PhD, Psychologist, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Clinical Psychology, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy. E-mail: [email protected] (A. Bottacini).
Since the previous report published in 2011 [1], there has not been considerable progress towards wider implementation of shared decision making (SDM) in Italy. Patients are invited to actively participate in their healthcare decisions and advocate for
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Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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SDM policies in their community [2]. Based on scientific evidence, we are aware of the process and principles underpinning medical decision-making. Decision-making in healthcare has different levels [3]: a) the macro level - decisions on resource allocation and utilization; b) the meso level - clinical decisions on optimal treatment policies for groups of patients with the same disease or similar clinical characteristics, e.g. development of guidelines; c) the micro level - refers to SDM for the individual patient. In recent years, the public has advocated for support at all three levels. The aim of this paper is to update the current state of patient and public participation in healthcare in Italy. This paper provides a description of: i) the Italian National Health Service organization; ii) the latest governmental and institutional initiatives regarding patient participation; iii) the current associations and initiatives promoting patient participation; iv) the latest research projects on patient participation published in peer-reviewed journals; and v) the training initiatives to promote patient participation. We searched the official websites of the Italian Ministry of Health to retrieve relevant documents, and identify individuals working in the area of shared decision making [4]. We also conducted a literature review using the PubMed and Cochrane databases to identify research articles on patient participation and shared decision-making (SDM) in Italy since 2011 using the following key words: patient participation, patient involvement, empowerment, shared decision-making and Italy. We also searched Google, using the same key words, to find Italian sites discussing initiatives related to patient participation in health care and SDM. The following paragraphs aim to give a general overview of the current initiatives in Italy regarding SDM and patient participation in healthcare, and is not meant to be exhaustive. Brief Description of the Italian National Health Service The Italian National Health Service (Servizio Sanitario Nazionale/SSN) was established with the aim of providing efficient, universal healthcare to all Italians, regardless of socioeconomic status, employment status, or pre-existing health conditions. The organization functions at three levels: national, regional and local. The institution at the national level is the Ministry of Health (Ministero della Salute) [4]. It is responsible for setting the overall objectives of the SSN (through the National Health Plan), controlling the drug market and its related research (in conjunction with the Italian drug agency: Agenzia Italiana del Farmaco - AIFA), national prevention programs (e.g., information on vaccinations) and veterinary medicine. It also coordinates a cooperation of 40 public and private hospitals (Instituti di Ricovero e Cura a Carattere Scientifico - IRCCS) which are dedicated to research. The regional government is responsible for planning, financing, controlling, and supervising the efficacy, quality and the provision of services through public and private health organizations at the regional level. On the local level, more than 200 local health authorities (Azienda Sanitaria Locale/ASL) administer the SSN. Governmental and institutional initiatives regarding patients’ and citizens’ participation The 2010-2012 National Health Plan, yet to be updated by policymakers, recognizes the importance of patient participation in decision-making processes, and highlights the paradigm of patientcentered medicine oriented towards a ‘‘shared and active health promotion’’ [5]. In this context, doctor-patient communication and patients’ involvement in treatment decisions are essential. Patients are considered ‘‘empowered’’ if they have the ‘‘knowledge,
awareness and ability necessary for influencing their own and others’ behaviors, in order to improve their quality of life’’. Policymakers acknowledge that people need to play an active role in planning, controlling and evaluating the health and social services both at regional and local health authority level. A more recent plan is the Prevention Plan (2014-2018) [6] that stresses the importance of preventative medicine in health, but does not explicitly mention shared decision making or patient involvement. However, it underlines the vision of creating a patient-centered culture where citizens (both healthy and ill), with their expectations and needs, are the focal point. The shared decision making community has yet to reach a consensus on a clear definition of shared decision making. The lack of ‘common language’ is reflected in the Plan, and makes it difficult to compare the Italian situation with other European countries. Moreover, we recognize the lack of tools for evaluating SDM processes at macro and meso levels. The Italian version of the OPTION scale [7] and the Shared Decision Making-Questionnaire (SDM-Q-9) [8] remain the only validated scales used at the micro level for evaluating SDM in terms of the doctors’ abilities and the patients’ perspective.
Examples of associations and initiatives promoting patient participation at the meso and macro level In recent years, few projects aimed at organizing and promoting patient participation in healthcare have been endorsed by public and private institutions. In 2016, a conference titled:’’ Promoting patient engagement in care processes with evidence-based and impact measures’’ took place in Milan, Italy [9]. The workshops included different representatives involved in the promotion of patient engagement and participation (eg. researchers, clinicians, patient associations, experts of new technology). The conference was part of a larger research program promoted by the Lombardy region, called ‘‘Open Innovation project [10]’’. The project aimed at reaching an agreement among experts on the most effective tools and strategies to promote patient engagement. Several experts from various sectors of the medical, business, and academic communities attended the event with the objective of setting evidence-based recommendations for the patient’s active involvement in the healthcare process. Throughout the conference, experts highlighted the change in perception of patient’s role as ‘‘an epochal transformation’’. They stressed the importance of the patient’s active involvement in prevention and treatment phases, since the aging of the population is directly proportional to the increase in chronic diseases. Unfortunately, the growing attention to patient engagement by researchers is not correlated with an increase in concrete initiatives to promote the patient’s active involvement. ‘‘Partecipa salute’’ (Participate in health care) [11] remains an active project promoted by The Mario Negri Research Institute (Milan) aimed at fostering a strategic alliance between patients (or groups) and professionals (institutions and/or societies), with the common goal of promoting better health care and patients’ involvement. The non-profit organization ‘‘Cittadinanza attiva’’ (Active Citizenship) [12] remains very active on the national front with the primary aim of promoting civic participation for the care of the common good, particularly healthcare, and the defense of citizens’ rights. Another example of associations working to promote and protect patient’s rights is ‘‘Difesa del Malato’’ (Ill Person Defense) [13]. It raises awareness, through social media, of elements that could jeopardize the health of individuals. In addition, it promotes cultural activities to increase participation and commitment in Italian communities.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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Setting
Aims
Main findings
Giordano et al., 2012 [14]
Oncology
To provide the public with the best estimates of benefits and harms of breast cancer screening through the balance sheet tool.
Arcuri et al., 2013 [18]
General practice
Pietrolongo et al., 2013 [26]
Multiple sclerosis (MS)
To test for differences between experts and lay people in assessment of the degree to which a doctor engaged in a shared decision-making with a patient, using the OPTION scale and a movie clip as stimulus material. To assess decision-making from third observer and patient perspectives in MS.
Chiavari et al., 2015 [15]
Oncology
The balance sheet can be seen as a tool to convey estimates based on the best available evidence. It reflects a re-assessment of screening efficacy, showing again that screening is effective and brings more benefits than harms. Being female and being familiar with medical issues were both significantly associated with negative evaluations of the doctor’s ability to involve the patient in the SDM.. Findings indicated limited patient involvement abilities of MS physicians during first consultation and the need to empower Italian MS physician with better communication and shared decision-making skills. DeCo significantly improved SDM and reduced scores of Decisional Conflict Scale (DCS).
Fumagalli et al., 2015* [19]
General practice
Goss et al., 2015 [16]
Oncology
Sacchi et al., 2015* [20]
General practice
Sacchi et al., 2015 [25]
Cardiology
Strauss et al., 2015 [30]
Autism Spectrum Disorders (ASD)
Fadda et al., 2016 [22]
Pediatrics
Gorini et al., 2016* [17]
Oncology
To analyze cancer Decision Aids (DAs) with a particular attention to their level of personalization.
Guarinoni et al., 2016* [28]
Nursing
To explore the literature regarding the model of the Shared Decision Making (SDM) in the field of nursing, in a time range between 1972 and 2015.
Mariani et al., 2016 [29]
Long-term care
To identify barriers and facilitators regarding the implementation of an SDM framework for care planning in two nursing homes, one in Italy and one in the Netherlands.
Renzi et al., 2016* [24]
Hematology
Rosati et al., 2017 [23]
Pediatrics
Zanini et a, 2016 [21]
Chronic pain
D’Amico et al., 2016 [27]
Multiple Sclerosis
To propose a patient-centred model and a shared decision making (SDM) approach to treatment switch in chronic hematological conditions, in particular chronic myeloid leukemia, atrial fibrillation, and -thalassemia. To assess general parental views on SDM and patient-physician SDM relationships in an Italian pediatric outpatients’ clinic. This study examined whether and how a pre-consultation sheet (PCS) that captures patients’ views on their condition and treatments can facilitate doctors in identifying targets for medical advice. This study conducted in patients with multiple sclerosis (MS), examined several factors in relation to the patient’s role in the therapeutic decision-making process.
To evaluate the effects of a decision-making support (Decision Counseling-DeCo) on decision making, decisional conflict, and anxiety in cancer patients facing with values-based decisions on fertility and procreation or genetic testing and risk reduction options in oncology. Delivering an evidence-based concept mapping through a review (1990-2013) of the definitions of patient empowerment, engagement, enablement, activation, involvement, and participation that delineates their boundaries and mutual relationships. To observe the patient involvement through the frequency and type of questions asked by Italian breast cancer patients and to explore factors associated. To highlight the latest trends (2012-2014) on the development, use, and evaluation of Information and Communication Technologies (ICT) based Decision support systems (DSSs) in medicine, with a particular focus on patient-centred and personalized care. To propose a unified framework to promote the shift from a traditional, physician-centred, clinical decision process to a more personalized, patient-oriented shared decision-making (SDM) environment. To investigate to what extent the staff’s competence in SDM contributes to positive child and parent improvement when involving parents in Early Intensive Behavior Interventions (EIBI). To verify whether SDM staff competence contributes to a child’s treatment responsiveness. To gain insights from parents residing in a low measles-mumps-rubella (MMR) uptake area on what constitutes feelings of empowerment in the decision they have to make on their child’s MMR vaccination.
Through the review a concept mapping for the different terms was delineated. The map consists of two dimensions (nature and focus of concept) and marks distinctions and relationships between the concepts. Italian breast cancer patients asked on average more questions than in other countries, mainly about illness management. Other factors related to a greater number of questions were younger age, being employed, and longer consultation length. Although decision support through the delivery of recommendations is frequent, the review highlighted that patient participation in making decisions is still limited, and mostly focused on risk communication. The results point out the importance of running personalized decision models, which can substantially differ from models quantified with population coefficients. Parent inclusion should be conceptualized as a collaborative partnership model rather than as adherence in treatment provision, based on a target SDM staff training that may constitute an external contributor to treatment responsiveness. Autonomy and competence were salient themes in relation to empowerment, and were further connected with beliefs regarding legal responsibility and ethics of freedom. Competence was interpreted as medical knowledge and information-seeking skills. Only few of the existing randomized controlled studies on cancer DAs analyzed took into account individual variables such as cultural level, individual risk attitudes, personal beliefs, and emotional state. The analysis identifies the main characteristics of the SDM model, the tools for its implementation, the patients experience, the fields of application and the integration among SDM e evidence based practice. Through focus group interviews with health-care professionals, the categories of team collaboration, communication skills and nursing home policy were found to be facilitators to the implementation process, whereas regulations, lack of funding and of involvement of family caregivers were the main barriers. Within this framework, decision aids may represent a valid support to the patient–physician relationship.
Highly educated parents preferred SDM for choosing their child’s therapy and this approach reassured them. The PCS captures patients’ views that are valuable in helping doctors identify targets of intervention. It focuses on aspects that matter to patients and that enrich information sharing beyond medical records. Of 100 patients with MS, 40 had a passive attitude, while 35 were willing to collaborate and 25 wanted to play an active role in the decision-making process.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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Published research projects Our literature search on patient participation and shared decision making in Italy uncovered 17 new articles published in peer-reviewed journals between 2012 and 2017 (Table 1). We used the same key words used in the 2011 paper: shared decision-making, Italy, patient involvement, patient participation and empowerment. The articles discuss SDM in a variety of settings. Four studies involve oncology settings [14–17], four focus on SDM in general practice [18–21], two are conducted in pediatrics [22,23] and the others are in the following medical areas: hematology [24], cardiology [25], multiple sclerosis [26,27], nursing [28], long-term care [29], and autism [30] (See Table 1). Of the 17 articles, twelve are original research articles, four are reviews [17,19,20,28], and one is a theoretical paper [24]. The general aims of these studies were to examine the communication skills of physicians, and asses the different factors associated with facilitating the SDM approach. Other aims included: exploring patient and parents’ (in pediatric setting) perspectives on their involvement in healthcare decisions. The SDM approach was used in different medical settings using various decision support tools and counseling techniques. Results show that physicians need to improve their communication skills, [26] and that many use decision support resources only to provide risk communication [20]. Goss et al. found that younger patients, and patients who were employed, asked more questions and were more involved during their clinical consultation [16]. In an observational study conducted at a multiple sclerosis (MS) center in Catania, researchers found that the majority of patients diagnosed with MS were eager to collaborate or play an active role in the medical decision making process, and wanted to better understand the risk and benefits associated with each available treatment [27]. Furthermore, using decision counseling reduced decisional conflict among patients during oncofertility and oncogenetics consultations, and helped them feel understood [15]. Gorini et al. suggests that decision support counseling or tools should preferably be more interactive, and personalized to take into account the patient’s cultural background, personal beliefs, and emotional state [17]. Various shared decision making frameworks have been created to try and create a patient-centered environment in different clinical settings in the hopes of breaking down some of the barriers that hinder patient-physician communication [25,29]. With these frameworks in mind, new tools have been proposed to improve shared decision-making. Examples include the Decision Counseling (DeCo) by Chiavari et al. [15] and the Balance Sheet by Giordano et al. [14]. A tool known as the pre-consultation sheet (PCS) has also been developed for chronic pain consultations to help physicians identify topics that require further discussion with patients, and to better understand patient attitude and beliefs [21]. It is also important to note that researchers have focused on the role of patients’ family members in the shared decision making process [23,30]. Rosati et al. assessed parental views on SDM in an Italian pediatric outpatient clinic, and found that most parents felt assured by the SDM approach, and the overwhelming majority appreciated collaborating with the physician to make the treatment decision for the child [24]. Research has also been conducted to investigate the role of nurses in the implementation of the SDM approach in clinic workflow patterns [28].
Examples of educational training activities promoting patient involvement Courses are offered to students enrolled in medical school in Italy that discuss physician-patient communication and enhancing
the role of the patient in the clinical encounter. As cited in the previous 2011 review, there are a number of Italian associations that offer physicians communication training to help them empower patients to be more active in their care [1]. As far as we know, there is no national program to train physicians on how to practice the shared decision making approach. An important project that was initiated in 2008, known as HUCARE (HUmanization of CAncer caRE) [31], enables trained professionals to provide oncology patients with evidence-based information about their cancer with the hopes of addressing patients’ psychosocial needs. This project is ongoing and involves over 30 cancer centers and research institutes, and more than 700 health professionals and researchers. The HUCARE project offers many resources, one of which is the Question Prompt List (QPL), which is translated in Italian to help Italian-speaking cancer patients [32]. The efficacy of QPL has recently been assessed in Italian breast cancer setting [33]. Patients’ questions shed light on the type of information they need, and is an indication of their desire to be actively involved in the patient-physician interaction [16]. Conclusions The importance of patient participation in health care decisions in Italy is recognized by policy makers. There are initiatives endorsed by public and private institutions to promote patient and family engagement, however, much more work is needed in order to translate these efforts into practice. Patient associations all over Italy are actively trying to improve patient involvement in healthcare, and defending the right of patients to be adequately informed and actively engaged in all the processes regarded their health. Italian research is active and there are several projects and published papers exploring SDM in different medical settings. In conclusion, although shared decision making research, and the desire to shift to a more patient-centered approach in Italy has increased, there needs to be a more concerted effort at the government level, and at the clinical level to embed shared decision making. Excellent initiatives to empower patients are present in Italy, but more needs to be done to come to a consensus on the SDM ‘language’ to aid the implementation of this approach in clinical practice. Conflict of Interest None declared. References [1] Goss C, Mosconi P, Renzi C, Deledda G. Participation of patients and citizens in healthcare decisions in Italy. Z. Evid Fortbild Qual Gesundhwes (ZEFQ) 2011;105(4):277–82. [2] Elwood P, Longley M. My health: whose responsibility? A jury decides. J Epidemiol Comm Health 2010;64:761–4. [3] Stiggelbout AM, de Haes JC. Patient preferences for cancer therapy: an overview of measurement approaches. J Clin Oncol 2001;19:220–30. [4] Ministero della salute. http://www.ministerosalute.it Latest access, April 2017. [5] Ministero della Salute. http://www.salute.gov.it/portale/documentazione. Latest access, April 2017. [6] Ministero della salute Piano nazionale della salute 2014-2018. http://www. salute.gov.it/imgs/C 17 pubblicazioni 2285 allegato.pdf. Latest access, April 2017. [7] Goss C, Fontanesi S, Mazzi MA, Del Piccolo L, Rimondini M. The assessment of patient involvement across consultation. The Italian version of the OPTION scale (in Italian). Epidemiol Psychiatr Soc 2007;16:339–49. [8] Renzi C, Mastroeni S, Pagliarello L, Passalacqua S, Tabolli S, Simon D, et al. Shared decision-making among patients with chronic skin diseases. The International Conference on Communication in Healthcare (EACH) Poster Session, Tuesday, 7 September 2010; P2.3.01. [9] Consensus conference for patient engagement https://ec.europa.eu/ eip/ageing/commitments-tracker/b3/consensus-conference-patientengagement en. Latest access, April 2017.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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Contents lists available at ScienceDirect
Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) journal homepage: http://www.elsevier.com/locate/zefq
Shared decision making in Italy: An updated revision of the current situation Partizipative Entscheidungsfindung in Italien: die aktuelle Situation im Überblick Alessandro Bottacini 1,∗ , Peter Scalia 2 , Claudia Goss 1 1 2
Department of Neurosciences, Biomedicine and Movement Sciences, Section of Clinical Psychology, University of Verona, Verona, Italy The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, 1 Medical Center Drive, Lebanon, USA
a r t i c l e
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Keywords: shared decision making public health patient participation Italy
a r t i k e l
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Schlüsselwörter: partizipative Entscheidungsfindung Public Health Patientenbeteiligung Italien
a b s t r a c t The aim of this paper is to update the previous review on the state of patient and public participation in healthcare in Italy. Policymakers consider patient involvement an important aspect in health care decisions and encourage patients to actively participate in the clinical interaction. Nevertheless, the term shared decision making (SDM) is still not clearly defined. Patient associations promote patient participation in health care decisions. Several experts attended the latest consensus conference about patient engagement to reach a consensus on the definition of SDM. Research regarding SDM in Italy continues to increase with 17 articles published between 2012 and 2017. Researchers have assessed the variables associated with patient involvement and explored the use of the SDM approach in different medical settings. Despite the dedicated SDM initiative, researchers in Italy recognize room for improvement. Work is needed to reach a common language regarding SDM and its mechanisms to implement this approach at the clinical level.
z u s a m m e n f a s s u n g Der vorliegende Beitrag stellt die Aktualisierung eines früheren Reviews zum Stand der Partizipation von Patienten und der Öffentlichkeit am italienischen Gesundheitswesen dar. Politische Entscheidungsträger sehen die aktive Beteiligung von Patienten an gesundheitsbezogenen Entscheidungen als wichtig an, auch wenn der Begriff ‘‘partizipative Entscheidungsfindung‘‘ (PEF), so wie er uns geläufig ist, noch nicht ausdrücklich erwähnt oder beschrieben worden ist. Von den Patientenverbänden wird die Partizipation der Patienten und Bürger an gesundheitsbezogenen Entscheidungen aktiv gefördert. Mehrere Experten nahmen an der letzten Konsensuskonferenz zur Patientenbeteiligung teil, um zu einer gemeinsamen Definition von PEF zu gelangen. Die Forschungstätigkeit zum Thema PEF hat in Italien zugenommen. So wurden von 2012 bis 2017 17 Beiträge publiziert, in denen verschiedene mit Patiententeilhabe verbundene Parameter sowie der Einsatz von PEF in unterschiedlichen medizinischen Bereichen untersucht wurden. Trotz der Initiative zur Förderung von PEF sehen Wissenschaftler in Italien noch Raum für Verbesserungen. So sollten weitere Anstrengungen unternommen werden, um zu einem einheitlichen Verständnis bezüglich PEF und der Mechanismen zu gelangen, mit deren Hilfe PEF im klinischen Bereich implementiert werden kann.
Introduction ∗ Corresponding author: Alessandro Bottacini, PhD, Psychologist, Department of Neurosciences, Biomedicine and Movement Sciences, Section of Clinical Psychology, University of Verona, Policlinico G.B. Rossi, Piazzale L.A. Scuro 10, 37134 Verona, Italy. E-mail: [email protected] (A. Bottacini).
Since the previous report published in 2011 [1], there has not been considerable progress towards wider implementation of shared decision making (SDM) in Italy. Patients are invited to actively participate in their healthcare decisions and advocate for
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Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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SDM policies in their community [2]. Based on scientific evidence, we are aware of the process and principles underpinning medical decision-making. Decision-making in healthcare has different levels [3]: a) the macro level - decisions on resource allocation and utilization; b) the meso level - clinical decisions on optimal treatment policies for groups of patients with the same disease or similar clinical characteristics, e.g. development of guidelines; c) the micro level - refers to SDM for the individual patient. In recent years, the public has advocated for support at all three levels. The aim of this paper is to update the current state of patient and public participation in healthcare in Italy. This paper provides a description of: i) the Italian National Health Service organization; ii) the latest governmental and institutional initiatives regarding patient participation; iii) the current associations and initiatives promoting patient participation; iv) the latest research projects on patient participation published in peer-reviewed journals; and v) the training initiatives to promote patient participation. We searched the official websites of the Italian Ministry of Health to retrieve relevant documents, and identify individuals working in the area of shared decision making [4]. We also conducted a literature review using the PubMed and Cochrane databases to identify research articles on patient participation and shared decision-making (SDM) in Italy since 2011 using the following key words: patient participation, patient involvement, empowerment, shared decision-making and Italy. We also searched Google, using the same key words, to find Italian sites discussing initiatives related to patient participation in health care and SDM. The following paragraphs aim to give a general overview of the current initiatives in Italy regarding SDM and patient participation in healthcare, and is not meant to be exhaustive. Brief Description of the Italian National Health Service The Italian National Health Service (Servizio Sanitario Nazionale/SSN) was established with the aim of providing efficient, universal healthcare to all Italians, regardless of socioeconomic status, employment status, or pre-existing health conditions. The organization functions at three levels: national, regional and local. The institution at the national level is the Ministry of Health (Ministero della Salute) [4]. It is responsible for setting the overall objectives of the SSN (through the National Health Plan), controlling the drug market and its related research (in conjunction with the Italian drug agency: Agenzia Italiana del Farmaco - AIFA), national prevention programs (e.g., information on vaccinations) and veterinary medicine. It also coordinates a cooperation of 40 public and private hospitals (Instituti di Ricovero e Cura a Carattere Scientifico - IRCCS) which are dedicated to research. The regional government is responsible for planning, financing, controlling, and supervising the efficacy, quality and the provision of services through public and private health organizations at the regional level. On the local level, more than 200 local health authorities (Azienda Sanitaria Locale/ASL) administer the SSN. Governmental and institutional initiatives regarding patients’ and citizens’ participation The 2010-2012 National Health Plan, yet to be updated by policymakers, recognizes the importance of patient participation in decision-making processes, and highlights the paradigm of patientcentered medicine oriented towards a ‘‘shared and active health promotion’’ [5]. In this context, doctor-patient communication and patients’ involvement in treatment decisions are essential. Patients are considered ‘‘empowered’’ if they have the ‘‘knowledge,
awareness and ability necessary for influencing their own and others’ behaviors, in order to improve their quality of life’’. Policymakers acknowledge that people need to play an active role in planning, controlling and evaluating the health and social services both at regional and local health authority level. A more recent plan is the Prevention Plan (2014-2018) [6] that stresses the importance of preventative medicine in health, but does not explicitly mention shared decision making or patient involvement. However, it underlines the vision of creating a patient-centered culture where citizens (both healthy and ill), with their expectations and needs, are the focal point. The shared decision making community has yet to reach a consensus on a clear definition of shared decision making. The lack of ‘common language’ is reflected in the Plan, and makes it difficult to compare the Italian situation with other European countries. Moreover, we recognize the lack of tools for evaluating SDM processes at macro and meso levels. The Italian version of the OPTION scale [7] and the Shared Decision Making-Questionnaire (SDM-Q-9) [8] remain the only validated scales used at the micro level for evaluating SDM in terms of the doctors’ abilities and the patients’ perspective.
Examples of associations and initiatives promoting patient participation at the meso and macro level In recent years, few projects aimed at organizing and promoting patient participation in healthcare have been endorsed by public and private institutions. In 2016, a conference titled:’’ Promoting patient engagement in care processes with evidence-based and impact measures’’ took place in Milan, Italy [9]. The workshops included different representatives involved in the promotion of patient engagement and participation (eg. researchers, clinicians, patient associations, experts of new technology). The conference was part of a larger research program promoted by the Lombardy region, called ‘‘Open Innovation project [10]’’. The project aimed at reaching an agreement among experts on the most effective tools and strategies to promote patient engagement. Several experts from various sectors of the medical, business, and academic communities attended the event with the objective of setting evidence-based recommendations for the patient’s active involvement in the healthcare process. Throughout the conference, experts highlighted the change in perception of patient’s role as ‘‘an epochal transformation’’. They stressed the importance of the patient’s active involvement in prevention and treatment phases, since the aging of the population is directly proportional to the increase in chronic diseases. Unfortunately, the growing attention to patient engagement by researchers is not correlated with an increase in concrete initiatives to promote the patient’s active involvement. ‘‘Partecipa salute’’ (Participate in health care) [11] remains an active project promoted by The Mario Negri Research Institute (Milan) aimed at fostering a strategic alliance between patients (or groups) and professionals (institutions and/or societies), with the common goal of promoting better health care and patients’ involvement. The non-profit organization ‘‘Cittadinanza attiva’’ (Active Citizenship) [12] remains very active on the national front with the primary aim of promoting civic participation for the care of the common good, particularly healthcare, and the defense of citizens’ rights. Another example of associations working to promote and protect patient’s rights is ‘‘Difesa del Malato’’ (Ill Person Defense) [13]. It raises awareness, through social media, of elements that could jeopardize the health of individuals. In addition, it promotes cultural activities to increase participation and commitment in Italian communities.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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A. Bottacini et al. / Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) xxx (2017) xxx–xxx Table 1 Description of the retrieved studies (* review or theoretical papers). Study
Setting
Aims
Main findings
Giordano et al., 2012 [14]
Oncology
To provide the public with the best estimates of benefits and harms of breast cancer screening through the balance sheet tool.
Arcuri et al., 2013 [18]
General practice
Pietrolongo et al., 2013 [26]
Multiple sclerosis (MS)
To test for differences between experts and lay people in assessment of the degree to which a doctor engaged in a shared decision-making with a patient, using the OPTION scale and a movie clip as stimulus material. To assess decision-making from third observer and patient perspectives in MS.
Chiavari et al., 2015 [15]
Oncology
The balance sheet can be seen as a tool to convey estimates based on the best available evidence. It reflects a re-assessment of screening efficacy, showing again that screening is effective and brings more benefits than harms. Being female and being familiar with medical issues were both significantly associated with negative evaluations of the doctor’s ability to involve the patient in the SDM.. Findings indicated limited patient involvement abilities of MS physicians during first consultation and the need to empower Italian MS physician with better communication and shared decision-making skills. DeCo significantly improved SDM and reduced scores of Decisional Conflict Scale (DCS).
Fumagalli et al., 2015* [19]
General practice
Goss et al., 2015 [16]
Oncology
Sacchi et al., 2015* [20]
General practice
Sacchi et al., 2015 [25]
Cardiology
Strauss et al., 2015 [30]
Autism Spectrum Disorders (ASD)
Fadda et al., 2016 [22]
Pediatrics
Gorini et al., 2016* [17]
Oncology
To analyze cancer Decision Aids (DAs) with a particular attention to their level of personalization.
Guarinoni et al., 2016* [28]
Nursing
To explore the literature regarding the model of the Shared Decision Making (SDM) in the field of nursing, in a time range between 1972 and 2015.
Mariani et al., 2016 [29]
Long-term care
To identify barriers and facilitators regarding the implementation of an SDM framework for care planning in two nursing homes, one in Italy and one in the Netherlands.
Renzi et al., 2016* [24]
Hematology
Rosati et al., 2017 [23]
Pediatrics
Zanini et a, 2016 [21]
Chronic pain
D’Amico et al., 2016 [27]
Multiple Sclerosis
To propose a patient-centred model and a shared decision making (SDM) approach to treatment switch in chronic hematological conditions, in particular chronic myeloid leukemia, atrial fibrillation, and -thalassemia. To assess general parental views on SDM and patient-physician SDM relationships in an Italian pediatric outpatients’ clinic. This study examined whether and how a pre-consultation sheet (PCS) that captures patients’ views on their condition and treatments can facilitate doctors in identifying targets for medical advice. This study conducted in patients with multiple sclerosis (MS), examined several factors in relation to the patient’s role in the therapeutic decision-making process.
To evaluate the effects of a decision-making support (Decision Counseling-DeCo) on decision making, decisional conflict, and anxiety in cancer patients facing with values-based decisions on fertility and procreation or genetic testing and risk reduction options in oncology. Delivering an evidence-based concept mapping through a review (1990-2013) of the definitions of patient empowerment, engagement, enablement, activation, involvement, and participation that delineates their boundaries and mutual relationships. To observe the patient involvement through the frequency and type of questions asked by Italian breast cancer patients and to explore factors associated. To highlight the latest trends (2012-2014) on the development, use, and evaluation of Information and Communication Technologies (ICT) based Decision support systems (DSSs) in medicine, with a particular focus on patient-centred and personalized care. To propose a unified framework to promote the shift from a traditional, physician-centred, clinical decision process to a more personalized, patient-oriented shared decision-making (SDM) environment. To investigate to what extent the staff’s competence in SDM contributes to positive child and parent improvement when involving parents in Early Intensive Behavior Interventions (EIBI). To verify whether SDM staff competence contributes to a child’s treatment responsiveness. To gain insights from parents residing in a low measles-mumps-rubella (MMR) uptake area on what constitutes feelings of empowerment in the decision they have to make on their child’s MMR vaccination.
Through the review a concept mapping for the different terms was delineated. The map consists of two dimensions (nature and focus of concept) and marks distinctions and relationships between the concepts. Italian breast cancer patients asked on average more questions than in other countries, mainly about illness management. Other factors related to a greater number of questions were younger age, being employed, and longer consultation length. Although decision support through the delivery of recommendations is frequent, the review highlighted that patient participation in making decisions is still limited, and mostly focused on risk communication. The results point out the importance of running personalized decision models, which can substantially differ from models quantified with population coefficients. Parent inclusion should be conceptualized as a collaborative partnership model rather than as adherence in treatment provision, based on a target SDM staff training that may constitute an external contributor to treatment responsiveness. Autonomy and competence were salient themes in relation to empowerment, and were further connected with beliefs regarding legal responsibility and ethics of freedom. Competence was interpreted as medical knowledge and information-seeking skills. Only few of the existing randomized controlled studies on cancer DAs analyzed took into account individual variables such as cultural level, individual risk attitudes, personal beliefs, and emotional state. The analysis identifies the main characteristics of the SDM model, the tools for its implementation, the patients experience, the fields of application and the integration among SDM e evidence based practice. Through focus group interviews with health-care professionals, the categories of team collaboration, communication skills and nursing home policy were found to be facilitators to the implementation process, whereas regulations, lack of funding and of involvement of family caregivers were the main barriers. Within this framework, decision aids may represent a valid support to the patient–physician relationship.
Highly educated parents preferred SDM for choosing their child’s therapy and this approach reassured them. The PCS captures patients’ views that are valuable in helping doctors identify targets of intervention. It focuses on aspects that matter to patients and that enrich information sharing beyond medical records. Of 100 patients with MS, 40 had a passive attitude, while 35 were willing to collaborate and 25 wanted to play an active role in the decision-making process.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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Published research projects Our literature search on patient participation and shared decision making in Italy uncovered 17 new articles published in peer-reviewed journals between 2012 and 2017 (Table 1). We used the same key words used in the 2011 paper: shared decision-making, Italy, patient involvement, patient participation and empowerment. The articles discuss SDM in a variety of settings. Four studies involve oncology settings [14–17], four focus on SDM in general practice [18–21], two are conducted in pediatrics [22,23] and the others are in the following medical areas: hematology [24], cardiology [25], multiple sclerosis [26,27], nursing [28], long-term care [29], and autism [30] (See Table 1). Of the 17 articles, twelve are original research articles, four are reviews [17,19,20,28], and one is a theoretical paper [24]. The general aims of these studies were to examine the communication skills of physicians, and asses the different factors associated with facilitating the SDM approach. Other aims included: exploring patient and parents’ (in pediatric setting) perspectives on their involvement in healthcare decisions. The SDM approach was used in different medical settings using various decision support tools and counseling techniques. Results show that physicians need to improve their communication skills, [26] and that many use decision support resources only to provide risk communication [20]. Goss et al. found that younger patients, and patients who were employed, asked more questions and were more involved during their clinical consultation [16]. In an observational study conducted at a multiple sclerosis (MS) center in Catania, researchers found that the majority of patients diagnosed with MS were eager to collaborate or play an active role in the medical decision making process, and wanted to better understand the risk and benefits associated with each available treatment [27]. Furthermore, using decision counseling reduced decisional conflict among patients during oncofertility and oncogenetics consultations, and helped them feel understood [15]. Gorini et al. suggests that decision support counseling or tools should preferably be more interactive, and personalized to take into account the patient’s cultural background, personal beliefs, and emotional state [17]. Various shared decision making frameworks have been created to try and create a patient-centered environment in different clinical settings in the hopes of breaking down some of the barriers that hinder patient-physician communication [25,29]. With these frameworks in mind, new tools have been proposed to improve shared decision-making. Examples include the Decision Counseling (DeCo) by Chiavari et al. [15] and the Balance Sheet by Giordano et al. [14]. A tool known as the pre-consultation sheet (PCS) has also been developed for chronic pain consultations to help physicians identify topics that require further discussion with patients, and to better understand patient attitude and beliefs [21]. It is also important to note that researchers have focused on the role of patients’ family members in the shared decision making process [23,30]. Rosati et al. assessed parental views on SDM in an Italian pediatric outpatient clinic, and found that most parents felt assured by the SDM approach, and the overwhelming majority appreciated collaborating with the physician to make the treatment decision for the child [24]. Research has also been conducted to investigate the role of nurses in the implementation of the SDM approach in clinic workflow patterns [28].
Examples of educational training activities promoting patient involvement Courses are offered to students enrolled in medical school in Italy that discuss physician-patient communication and enhancing
the role of the patient in the clinical encounter. As cited in the previous 2011 review, there are a number of Italian associations that offer physicians communication training to help them empower patients to be more active in their care [1]. As far as we know, there is no national program to train physicians on how to practice the shared decision making approach. An important project that was initiated in 2008, known as HUCARE (HUmanization of CAncer caRE) [31], enables trained professionals to provide oncology patients with evidence-based information about their cancer with the hopes of addressing patients’ psychosocial needs. This project is ongoing and involves over 30 cancer centers and research institutes, and more than 700 health professionals and researchers. The HUCARE project offers many resources, one of which is the Question Prompt List (QPL), which is translated in Italian to help Italian-speaking cancer patients [32]. The efficacy of QPL has recently been assessed in Italian breast cancer setting [33]. Patients’ questions shed light on the type of information they need, and is an indication of their desire to be actively involved in the patient-physician interaction [16]. Conclusions The importance of patient participation in health care decisions in Italy is recognized by policy makers. There are initiatives endorsed by public and private institutions to promote patient and family engagement, however, much more work is needed in order to translate these efforts into practice. Patient associations all over Italy are actively trying to improve patient involvement in healthcare, and defending the right of patients to be adequately informed and actively engaged in all the processes regarded their health. Italian research is active and there are several projects and published papers exploring SDM in different medical settings. In conclusion, although shared decision making research, and the desire to shift to a more patient-centered approach in Italy has increased, there needs to be a more concerted effort at the government level, and at the clinical level to embed shared decision making. Excellent initiatives to empower patients are present in Italy, but more needs to be done to come to a consensus on the SDM ‘language’ to aid the implementation of this approach in clinical practice. Conflict of Interest None declared. References [1] Goss C, Mosconi P, Renzi C, Deledda G. Participation of patients and citizens in healthcare decisions in Italy. Z. Evid Fortbild Qual Gesundhwes (ZEFQ) 2011;105(4):277–82. [2] Elwood P, Longley M. My health: whose responsibility? A jury decides. J Epidemiol Comm Health 2010;64:761–4. [3] Stiggelbout AM, de Haes JC. Patient preferences for cancer therapy: an overview of measurement approaches. J Clin Oncol 2001;19:220–30. [4] Ministero della salute. http://www.ministerosalute.it Latest access, April 2017. [5] Ministero della Salute. http://www.salute.gov.it/portale/documentazione. Latest access, April 2017. [6] Ministero della salute Piano nazionale della salute 2014-2018. http://www. salute.gov.it/imgs/C 17 pubblicazioni 2285 allegato.pdf. Latest access, April 2017. [7] Goss C, Fontanesi S, Mazzi MA, Del Piccolo L, Rimondini M. The assessment of patient involvement across consultation. The Italian version of the OPTION scale (in Italian). Epidemiol Psychiatr Soc 2007;16:339–49. [8] Renzi C, Mastroeni S, Pagliarello L, Passalacqua S, Tabolli S, Simon D, et al. Shared decision-making among patients with chronic skin diseases. The International Conference on Communication in Healthcare (EACH) Poster Session, Tuesday, 7 September 2010; P2.3.01. [9] Consensus conference for patient engagement https://ec.europa.eu/ eip/ageing/commitments-tracker/b3/consensus-conference-patientengagement en. Latest access, April 2017.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023
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[23] Rosati P, Di Salvo V, D’Amico R, Balduzzi S, Giampaolo R, Rita Marina Mazziotta M, Guerra C, Menichella G, Cosentino SP, Carlino C, Di Ciommo V. Outpatient parents’ views on shared-decision-making at an Italian children’s hospital. Health Promot Int 2017; pii: daw105. doi: 10.1093/heapro/daw105. [24] Renzi C, Riva S, Masiero M, Pravettoni G. The choice dilemma in chronic hematological conditions: Why choosing is not only a medical issue? A psychocognitive perspective. Crit Rev Oncol Hematol 2016;99:134–40. [25] Sacchi L, Rubrichi S, Rognoni C, Panzarasa S, Parimbelli E, Mazzanti A, Napolitano C, Priori SG, Quaglini S. From decision to shared-decision: Introducing patients’ preferences into clinical decision analysis. Artif Intell in Med 2015;65:19–28. [26] Pietrolongo E, Giordano A, Kleinefeld M, Confalonieri P, Lugaresi A, Tortorella C, Pugliatti M, Radice D, Goss C, Heesen C, Solari A. Decision-making in multiple sclerosis consultations in Italy: third observer and patient assessments. PloS One 2013;8:e60721. [27] D’Amico E, Leone C, Patti F. Disability may influence patient willingness to participate in decision making on first-line therapy in multiple sclerosis. Funct Neurol 2016;31:21–3. [28] Guarinoni MG, Dignani L, Motta PC. Shared decision making: a scoping review. Professioni Infermieristiche 2016;69:141–9. [29] Mariani E, Engels Y, Koopmans R, Chattat R, Vernooij-Dassen M. Shared decision-making on a ‘life-and-care plan’ in long-term care facilities: research protocol. Nursing Open 2016;3:179–87. [30] Strauss K, Benvenuto A, Battan B, Siracusano M, Terribili M, Curatolo P, Fava L. Promoting Shared Decision Making to strengthen outcome of young children with Autism Spectrum Disorders: The role of staff competence. Res Dev Disabil 2015;38:48–63. [31] http://www.hucare.it/ private/pdf/aboutus.pdf. Latest access, April 2017. [32] Caminiti C, Diodati F, Filiberti S, Marcomini B, Annunziata MA, Ollari M, Passalacqua R. Cross-cultural adaptation and patients’ judgments of a Question Prompt List for Italian-speaking cancer patients. BMC Health Services Research 2010;10:16. [33] Bottacini A, Goss C, Mazzi MA, Ghilardi A, Buizza C, Molino A, Fiorio E, Nortilli R, Amoroso V, Vassalli L, Brown RF. The involvement of early stage breast cancer patients during oncology consultations in Italy: a multi-centred, randomized controlled trial of a Question Prompt Sheet versus Question Listing. BMJ Open 2017; in press.
Please cite this article in press as: Bottacini A, et al. Shared decision making in Italy: An updated revision of the current situation. Z. Evid. Fortbild. Qual. Gesundh. wesen (ZEFQ) (2017), http://dx.doi.org/10.1016/j.zefq.2017.05.023