DLDaniela Leone

Daniela Leone

*This is an algorithmically generated author record based on publicly available information.

Current Organizations / Institutes

The organizations/institutes from the scholar's latest article


Daniela Leone has a total of 63 co-authors. Here are the top co-authors by number of shared publications:


Latest Publications

  • Open Access

    Multicentre pragmatic randomised controlled feasibility trial of fertiShare, a brief eLearning course to increase fertility staff performance when sharing bad news with their patients – a protocol

    by Sofia Gameiro, Daniela Leone, Arianna D’aNgelo, Zdravka Veleva, Richard Morey, Jacky Boivin

    Introduction Sharing bad news (SBN) is a recurring and stressful challenge for fertility staff and patients. Suboptimal SBN is associated with staff burnout, patient dissatisfaction with care and lack of trust in staff, potentially leading to patient discontinuation. Patients value staff having SBN skills, but staff feel unprepared to do this task. fertiShare is a 2-hour bespoke eLearning course to support fertility staff in SBN with their patients, organised into three modules, with each module offering video content-based lessons, simulated case studies showing optimal and suboptimal approaches to SBN and brief quizzes for self-reflection and assessment. This protocol aims to evaluate if it is feasible to implement fertiShare at UK-based fertility clinics and if it is acceptable to staff and patients. Methods and analysis Multicentre, two-arm, parallel-group, blinded, feasibility randomised controlled trial with 1:1 randomised staff allocation to fertiShare (intervention group) or general communication skills eLearning (control group). Six UK-based clinics, 60 staff spending a minimum of 10% week-time SBN and 360 patients having received bad news from participating staff within the last month will be recruited. Two cohorts of patients will be recruited, one after staff consent to the study and before fertiShare or control eLearning course (pretraining patient cohort) and another 1-month post staff training (post-training patient cohort). Outcome measures relate to demand, acceptability, implementation, practicality and limited efficacy testing, with the primary outcome being staff performance when SBN, reported by patients using an adapted version of the SBN Behavioural Assessment Scale. Recruitment and data collection will span from September 2025 to February 2026. Ethics and dissemination The study was approved by the National Health Service Research Ethics Committee (23/LO/0864) and the Cardiff University – School of Psychology Research Ethics Committee (EC.23.08.08.6827). Results will be disseminated via publications in peer-reviewed journals, conference presentations and public engagement, and will inform if fertiShare should proceed to efficacy evaluation. Insights from this study can inform the implementation of other SBN training in fertility or other healthcare domains and improve understanding of the impact SBN training has on patient experience and outcomes. Trial registration number NCT06587360, https://www.clinicaltrials.gov/


  • Open Access

    The end-of-treatment process in medically assisted reproduction: a qualitative study of healthcare professionals’ views

    by Federica Bonazza, Lidia Borghi, Sara Molgora, Elena Vegni, Daniela Leone

    In the medically assisted reproduction (MAR) pathway, one of the most complex phases is the end of the treatment. Unlike other medical contexts, there is no biological endpoint in the MAR setting. This absence makes the decision to end MAR treatment extremely challenging for both patients and healthcare professionals. Accordingly, our research aimed to examine the process related to the end of MAR treatment, as devised by healthcare professionals. Our sample included physicians, biologists, and psychologists aged ≥18 years with specialised training in assisted reproduction. Data were collected through four focus groups [in February-May 2023], focusing on the topic of the end of treatment (EoT) and its definition. Data were collected and analysed according to the principles of Grounded Theory. The findings shed light on the attributes and components related to the end of the treatment process. The central category "the end of treatment" consists of a definition of what is considered the end of treatment and the associated decision-making process. In the phase leading up to the EoT, the process is influenced by contextual and proximal factors, which interact and influence each other. To cope with and manage the EoT, healthcare providers adopt spontaneous strategies that lead to positives or negative outcomes. End-of-treatment management is a key facet of clinical practice. This contribution increased knowledge about EoT and highlighted healthcare professionals' perspectives, which should be considered for the implementation of best practice points and respect for patients' rights to the highest attainable standard of mental and physical health.

  • Open Access

    Fertility clinics have a duty of care towards patients who do not have children with treatment

    by S Gameiro, D Leone, H Mertes

    In medically assisted reproduction (MAR) success has mostly been measured in terms of achieving (healthy) livebirths. We argue this focus is too narrow and that success should be measured in terms of alleviating patient suffering caused by an unfulfilled child wish. The major implication is that clinics must better tailored care to effectively support patients who do not have child(ren) with treatment. First, we argue that clinics have a duty of care towards patients for whom MAR does not result in children because this is a common treatment outcome, because treatment is burdensome and creates new losses for patients, and because the field has the necessary expertise to provide support and it is part of patient-centred care. Then, we examine concerns about the adequacy of addressing the possibility that treatment may end without children, namely, that this may hinder patients’ hope and put them off doing treatment, and that it may be perceived as a sign of clinical incompetence, as well as concerns about the required skill set. We end with a set of research-informed recommendations to promote healthy adjustment to ending fertility treatment without children. These focus on the need to reconceptualize ‘success’ and ‘failure’ in MAR, to promote open discussion about the possibility of treatment not resulting in children and encourage patients to develop ‘plan(s) B’, to support patients who end treatment without children, and to create the organizational structures needed to support clinics and healthcare professionals in this endeavour.


  • Psychological Characteristics of Inflammatory Bowel Disease Patients: A Comparison Between Active and Nonactive Patients

    by Daniela Leone, Daniela Gilardi, Bianca E Corrò, Julia Menichetti, Elena Vegni, Carmen Correale, Allocca Mariangela, Federica Furfaro, Stefanos Bonovas, Laurent Peyrin-Biroulet, et al.

    The role of new psychological factors such as psychopathological patterns and defense mechanisms in the care of inflammatory bowel disease (IBD) has been poorly investigated. We aimed to assess the psychological characteristics and defense mechanisms of IBD patients. This was a single-center, observational, cross-sectional study. Consecutive adult IBD patients were enrolled and stratified according to disease activity. Sociodemographic and clinical data were collected, and validated questionnaires (Symptom Checklist-90-R [SCL-90-R]) for psychological distress, Defense Mechanism Inventory (DMI) for psychological defense mechanisms, and Inflammatory Bowel Disease Questionnaire (IBDQ) for quality of life (QoL) were administered. Two hundred one patients were enrolled: 101 in remission and 100 with active disease. The mean score for IBDQ was below the cutoff level (156.8 ± 37.8), with a significantly greater impairment of QoL in subjects with flares (136.5 vs 177.5, P < 0.001). Lower scores were associated with female gender. No patients had psychological scores above the cutoff for normality. Statistically higher SCL-90-R scores were found in active patients for obsessive-compulsive disorder (P = 0.026), depression (P = 0.013), anxiety (P = 0.013), phobic anxiety (P = 0.002), psychoticism (P = 0.007), global severity index (GSI) (P = 0.005) and positive symptom total (PST) (P = 0.001). A significantly increased probability of higher global indexes was associated with Crohn’s disease and disease flares. None of the defensive Defense Mechanism Inventory (DMI) styles resulted above the cutoff in our cohort. Further data are needed to demonstrate the potential key role of psychological intervention in the therapeutic strategies utilized for IBD patients, and the identification of specific psychological patterns based on the patients profile is necessary to optimize psychological intervention.


  • Illness Perception in Inflammatory Bowel Disease Patients is Different Between Patients With Active Disease or in Remission: A Prospective Cohort Study

    by Elena Vegni, Daniela Gilardi, Stefanos Bonovas, Bianca E Corrò, Julia Menichetti, Daniela Leone, Allocca Mariangela, Federica Furfaro, Silvio Danese, Gionata Fiorino

    Inflammatory bowel diseases [IBD] are characterised by significant quality of life [QoL] impairment, as well as illness perception. Assessing illness perception may help in optimising the management of IBD patients. In this single-centre, observational, transversal study, consecutive adult IBD patients were enrolled and stratified according to disease activity [active/remission]. The Revised Illness Perception Questionnaire [IPQ-R], based on identity, opinions, and causes of their disease was administered to all patients. Comparison within IPQ-R parameters was done between clinically active patients and those in remission. A total of 201 patients were enrolled (Crohn's disease [CD] = 47%). The most frequently reported IBD-related symptoms were fatigue [86.9%], loss of strength [83.3%], pain [80%], and weight loss [68.2%]. Active patients reported significantly more frequently fatigue [p = 0.005], sore eyes [p = 0.046], and sleep difficulties [p = 0.001], and reported more symptoms than controls [p = 0.023]. Overall, the patients considered stress [84.1%], altered immunity [69.32%], family problems [49.4%], and emotional status [40.9%] as the main causes of IBD. Work overload was more frequently considered as a disease cause in active patients than in those in remission [p = 0.002]. Smoking, family history, and previous inadequate therapies were considered as a relevant risk factor for illness by only 20% of patients. Active IBD patients had more negative thoughts on prognosis [p = 0.001] and more negative emotions [p < 0.0001]. Patients in remission were significantly more convinced about treatment control [p = 0.007] and had clearer understanding of illness [p = 0.009]. Illness perception is impaired in IBD patients. Adequate educational and psychological support may be helpful in the optimal management of IBD patients.


  • Open Access

    Doctor–couple communication during assisted reproductive technology visits

    by D Leone, L Borghi, S Del Negro, C Becattini, E Chelo, M Costa, L De Lauretis, A P Ferraretti, G Giuffrida, C Livi, et al.

    What are the characteristics of doctor–couple communication content during actual ART visits? Physicians were mainly focused on providing biomedical information, while communication content from couples had a 2-fold focus on providing biomedical information and on positive talk. Communication aspects in ART seem crucial for clinical decision-making, retention in care and critical conversations with couples due to low treatment success rates. However, no studies have been carried out on the actual interaction between the doctor and the couple in this context. This observational study involved 28 clinicians and 160 patients referred to eight Italian ART clinics during a one-year recruitment period. ART visits at eight Italian clinics were videotaped. The visits were coded using the Roter Interaction Analysis System (RIAS), particularly focusing on RIAS composite categories, verbal dominance and patient-centeredness score. A total of 85 visits were eligible for analysis (62% acceptance rate), involving 28 clinicians and 160 patients (including 75 couples). The average visit duration was 37 ± 17.7 min. The mean verbal dominance was 1.9 ± 0.86 (range: 0.72–5.74). Physicians mainly focused on providing biomedical information. Communication content from couples had a 2-fold focus on providing biomedical information and on positive talk. The mean of patient centeredness index (PCI) was 0.51 (SD = 0.28; range 0.08–1.77); visits in which the doctor was a woman or the treatment indication was for heterologous fertilization showed higher PCI scores. Overall, females accounted for 67% of all patient talk. Taking this imbalance into account as expected frequencies for each composite category, males reported significantly more utterances in almost all of the socioemotional categories. These results are preliminary and observational and only regard Italy. Communication during visits may have been biased since the professionals who agreed to participate showed an interest in communication issues. Another limitation is a possible Hawthorne effect due to the fact that participants were aware of being videotaped. Our study showed that ART physicians mainly adopted an informative model of communication and a more disease-oriented approach. Findings revealed the complexity of communication content during ART consultations, given its triadic characteristic in which the third party is also a patient; clinicians should be aware of this complex aspect and of the specific male and female perspectives to be taken into account. The results could be useful for training ART professionals. This study was possible thanks to an unconditional grant from Ferring Spa to the Department of Health Sciences, University of Milan. There are no competing interests to declare. N/A.


  • Open Access

    Breaking bad news in assisted reproductive technology: a proposal for guidelines

    by Daniela Leone, Julia Menichetti, Lorenzo Barusi, Elisabetta Chelo, Mauro Costa, Luciana De Lauretis, Anna Pia Ferraretti, Claudia Livi, Arne Luehwink, Giovanna Tomasi, et al.


  • Error disclosure and family members’ reactions: Does the type of error really matter?

    by Daniela Leone, Giulia Lamiani, Elena Vegni, Susan Larson, Debra L. Roter


  • State of the Art: Psychotherapeutic Interventions Targeting the Psychological Factors Involved in IBD

    by Daniela Leone, Julia Menichetti, Gionata Fiorino, Elena Vegni

    The present article aims to review the literature on the relationship between psychology and inflammatory bowel disease (IBD). In particular, the first section is dedicated to explore the role of psychological factors in the etiopathology of the disease, its development and the efficacy of treatments, while the second analyzes existing literature on the role of psychological interventions in the care of IBD patients. Although the role of psychological factors in IBD appears controversial, literature seems to distinguish between antecedents of the disease (stress and lifestyle behavior), potential mediators of disease course (family functioning, attachment style, coping strategies, and illness perception), outcomes of IBD and concurrent factors (anxiety, depression and quality of life). Four types of psychological interventions are described: Stress management, Psychodynamic, Cognitive behavioral and Hypnosis based. Data on the role and efficacy of psychological interventions in IBD patients show little evidence both on reduction of the disease activity and benefits on psychological variables. Psychological interventions seem to be beneficial in the short term especially for adolescents. The importance of considering the connections between psychology and IBD from a broader perspective reflecting the complexity of the phenomenon at multiple levels is discussed.