Toward a new personalized psycho-social approach for the support of prostate cancer and their caregivers dyads: a pilot study.

Introduction: Prostate cancer patients (PCP) often struggle with a significant emotional, physical, and social burden during the care-flow pathway. Noteworthy, PCP should not be considered a standalone patient, but someone who is connected with a relevant social environment and that is usually supported by a beloved one, the caregiver. The involvement of the caregivers through the care pathway might bring significant benefits both on the psychological and the treatment and decision-making side. The present pilot study aimed at preliminarily assessing quantitatively the psychological impact of a prostate cancer diagnosis on the degree of agreement of PCPs and their caregivers on medical decisions, coping resources and psychological distress levels. Methods: 16 PCP and their caregivers were enrolled in the study and fulfilled a battery of standardized questionnaires. Results: Results showed low concordance in decision making styles and preferences in patients and their caregivers and that the dyads showed similar depression symptoms levels. Relevant features of the psychological needs of the analyzed dyads, such as need for information and support, also emerged. Conclusion: On the basis of these preliminary results, guidelines for the construction of tailored brief psychological support interventions for PCP dyads are provided.

Cognitive trajectories after surgery: Guideline hints for assessment and treatment.

Elderly patients who undergo major surgery (not-neurosurgical) under general anaesthesia frequently complain about cognitive difficulties, especially during the first weeks after surgical "trauma". Although recovery usually occurs within a month, about one out of four patients develops full-blown postoperative Neurocognitive disorders (NCD) which compromise quality of life or daily autonomy. Mild/Major NCD affect approximately 10% of patients from three months to one year after major surgery. Neuroinflammation has emerged to have a critical role in the postoperative NCDs pathogenesis, through microglial activation and the release of pro-inflammatory cytokines which increase blood-brain-barrier permeability, enhance movement of leukocytes into the central nervous system (CNS) and favour the neuronal damage. Moreover, pre-existing Mild Cognitive Impairment, alcohol or drugs consumption, depression and other factors, together with several intraoperative and post-operative sequelae, can exacerbate the severity and duration of NCDs. In this context it is crucial rely on current progresses in serum and CSF biomarker analysis to frame neuroinflammation levels, along with establishing standard protocol for neuropsychological assessment (with specific set of tools) and to apply cognitive training or neuromodulation techniques to reduce the incidence of postoperative NCDs when required. It is recommended to identify those patients who would need such preventive intervention early, by including them in pre-operative and post-operative comprehensive evaluation and prevent the development of a full-blown dementia after surgery. This contribution reports all the recent progresses in the NCDs diagnostic classification, pathogenesis discoveries and possible treatments, with the aim to systematize current evidences and provide guidelines for multidisciplinary care.

Effectiveness of Serious Games in Improving Genetic Literacy and Genetic Risk Awareness in the General Public: A Pilot Study.

Background: Genomics is an integral part of medical science; however, European citizens' literacy on basic genetic concepts is still poor. The aim of this study was to evaluate the effectiveness of Serious Games (SGs) in increasing genetic literacy in laypeople and to assess the impact of SGs on participants' perceived self-efficacy (SE) in managing genetic risk implications. Materials and Methods: Two minigames and an adventure game were created, together with leaflets reporting the same information as the SGs. Sixty participants enrolled at baseline and completed a brief sociodemographic questionnaire and an ad hoc questionnaire assessing their genetic knowledge. They were assigned to the SGs group (30 subjects) or to the Leaflets group (30 subjects) by matching age and sex. Both groups had about 40 minutes to play the SGs or to read the leaflets. In the postlearning session, participants completed the same genetic knowledge questionnaires administered at baseline and five items from the Self-Efficacy Scale, whereas the SGs group also filled in the In-Game Experience Questionnaire. Results and Conclusion: Results showed that learning genetic concepts through SGs was comparable to learning through leaflets. Playing SGs was also associated with poor feelings of frustration or annoyance, good engagement in the game challenges and contents, and positive feelings, particularly in subjects under 30 years. Participants perceiving SE increased significantly in both Leaflets and SGs groups, but the effect was higher for SGs players. SGs have the potential to increase genetic literacy in the public by making the learning process more engaging, pleasant and by enhancing SE.

Research Priorities to Increase Confidence in and Acceptance of Health Preference Research: What Questions Should be Prioritized Now?

BACKGROUND AND OBJECTIVE: There has been an increase in the study and use of stated-preference methods to inform medicine development decisions. The objective of this study was to identify prioritized topics and questions relating to health preferences based on the perspective of members of the preference research community. METHODS: Preference research stakeholders from industry, academia, consultancy, health technology assessment/regulatory, and patient organizations were recruited using professional networks and preference-targeted e-mail listservs and surveyed about their perspectives on 19 topics and questions for future studies that would increase acceptance of preference methods and their results by decision makers. The online survey consisted of an initial importance prioritization task, a best-worst scaling case 1 instrument, and open-ended questions. Rating counts were used for analysis. The best-worst scaling used a balanced incomplete block design. RESULTS: One hundred and one participants responded to the survey invitation with 66 completing the best-worst scaling. The most important research topics related to the synthesis of preferences across studies, transferability across populations or related diseases, and method topics including comparison of methods and non-discrete choice experiment methods. Prioritization differences were found between respondents whose primary affiliation was academia versus other stakeholders. Academic researchers prioritized methodological/less studied topics; other stakeholders prioritized applied research topics relating to consistency of practice. CONCLUSIONS: As the field of health preference research grows, there is a need to revisit and communicate previous work on preference selection and study design to ensure that new stakeholders are aware of this work and to update these works where necessary. These findings might encourage discussion and alignment among different stakeholders who might hold different research priorities. Research on the application of previous preference research to new contexts will also help increase the acceptance of health preference information by decision makers.

Balancing benefits and risks in lung cancer therapies: patient preferences for lung cancer treatment alternatives.

Background: In the treatment of Non-Small Cell Lung Cancer (NSCLC) the combination of Immuno- Oncotherapy (IO) and chemotherapy (CT) has been found to be superior to IO or CT alone for patients' survival. Patients and clinicians are confronted with a preference sensitive choice between a more aggressive treatment with a greater negative effect on quality of life versus alternatives that are less effective but have fewer side effects. Objectives: The aims of this study were to: (a) quantify patients' preferences for relevant attributes related to Immuno-Oncotherapy treatment alternatives, and (b) evaluate the maximum acceptable risk (MAR)/Minimum acceptable benefit (MAB) that patients would accept for treatment alternatives. Methods: An online preference survey using discrete-choice experiment (DCE) was completed by NSCLC patients from two hospitals in Italy and Belgium. The survey asked patients' preferences for five patient- relevant treatment attributes. The DCE was developed using a Bayesian D-efficient design. DCE analyses were performed using mixed logit models. Information regarding patient demographics, health literacy, locus of control, and quality of life was also collected. Results: 307 patients (158 Italian, 149 Belgian), stage I to IV, completed the survey. Patients preferred treatments with a higher 5-year survival chance as the most important attribute over all the other attributes. Preference heterogeneity for the attribute weights depended on health literacy, patients' age and locus of control. Patients were willing to accept a substantially increased risks of developing side effects in exchange for the slightest increase (1%) in the chance of surviving at least 5 years from the diagnosis of cancer. Similarly, patients were willing to accept a switch in the mode of administration or complete loss of hair to obtain an increase in survival. Conclusion: In this study, the proportion of respondents who systematically preferred survival over all other treatment attributes was particularly high. Age, objective health literacy and locus of control accounted for heterogeneity in patients' preferences. Evidence on how NSCLC patients trade between survival and other NSCLC attributes can support regulators and other stakeholders on assessing clinical trial evidence and protocols, based on patients' conditions and socio-demographic parameters.

Patients as research partners in preference studies: learnings from IMI-PREFER.

BACKGROUND: There is growing recognition of the importance of patient and public stakeholder involvement (PPI) in patient preference research. However, limited evidence exists regarding the impact, barriers and enablers of PPI in preference studies. The Innovative Medicines Initiative (IMI)-PREFER project conducted a series of preference case studies which incorporated PPI. OBJECTIVE: To describe: (1) how PPI was operationalized in the PREFER case studies, (2) the impact of PPI, and (3) factors that served to impede and facilitate PPI. METHODS: We reviewed the PREFER final study reports to determine how patient partners were involved. We conducted a thematic framework analysis to characterize the impact of PPI and then administered a questionnaire to the PREFER study leads to identify barriers and facilitators to effective PPI. RESULTS: Eight PREFER case studies involved patients as research partners. Patient partners were involved in activities spanning all phases of the patient preference research process, including in study design, conduct and dissemination. However, the type and degree of patient partner involvement varied considerably. Positive impacts of PPI included improvements in the: (1) quality of the research and research process; (2) patient partner empowerment; (3) study transparency and dissemination of results; (4) research ethics, and (5) trust and respect between the research team and the patient community. Of the 13 barriers identified, the 3 most frequently reported were inadequate resources, insufficient time to fully involve patient partners, and uncertainty regarding how to operationalize the role of 'patient partner. Among the 12 facilitators identified, the two most frequently cited were (1) having a clearly stated purpose for involving patients as research partners; and (2) having multiple patient partners involved in the study. CONCLUSION: PPI had many positive impacts on the PREFER studies. Preference study leads with prior PPI experience reported a greater number of positive impacts than those with no such experience. In light of the numerous barriers identified, multi-faceted implementation strategies should be considered to support adoption, integration and sustainment of PPI within preference research. Additional case studies of patient partner involvement in preference research are needed as well to inform best practices in this area.

Research about patients' preferences for medicinal products and treatments is growing. Such research could be improved if patients were involved as 'research partners,' that is, as active members of the study team itself. To date, however, little is known about the actual experience of involving patients as partners in such research. This paper presents learnings from involving patients as partners in 8 case studies conducted as part of IMI-PREFER, a big, European-based project which aimed to develop recommendations about how to conduct preference research. Involving patients as partners led to improvements in the: (1) quality of the research and research process; (2) recruitment of participants; (3) content and design of patient-facing informational materials; and, (4) how and what study results were shared with patient communities. Our findings showed that it is important to plan for patient partners' involvement early on in the design of the preference study so as to ensure that they are fully integrated into the research team and their opportunity to contribute to all stages of the research is optimized. Such planning should address how patient partners will be paid, what their role responsibilities will include, how and when they will be trained and educated, and how they will be supported throughout the course of the study. Having a clearly stated purpose for involving patients as research partners, selecting patient partners who have had prior research experience and relationships with the researchers, and having multiple patient partners on the study team are all also helpful in supporting successful patient involvement. We need more people to share their experiences with involving patient partners in preference research so that we can continue to improve how this is done.

Decision-making process about prenatal genetic screening: how deeply do moms-to-be want to know from Non-Invasive Prenatal Testing?

BACKGROUND: Prenatal information may be obtained through invasive diagnostic procedures and non-invasive screening procedures. Several psychological factors are involved in the decision to undergo a non-invasive prenatal testing (NIPT) but little is known about the decision-making strategies involved in choosing a specific level of in-depth NIPT, considering the increased availability and complexity of NIPT options. The main aim of this work is to assess the impact of psychological factors (anxiety about pregnancy, perception of risk in pregnancy, intolerance to uncertainty), and COVID-19 pandemic on the type of NIPT chosen, in terms of the number of conditions that are tested. METHODS: A self-administered survey evaluated the decision-making process about NIPT. The final sample comprised 191 women (Mage = 35.53; SD = 4.79) who underwent a NIPT from one private Italian genetic company. Based on the test date, the sample of women was divided between "NIPT before COVID-19" and "NIPT during COVID-19". RESULTS: Almost all of the participants reported being aware of the existence of different types of NIPT and more than half reported having been informed by their gynecologist. Results showed no significant association between the period in which women underwent NIPT (before COVID-19 or during COVID-19) and the preferences for more expanded screening panel. Furthermore, regarding psychological variables, results showed a significant difference between perceived risk for the fetus based on the NIPT type groups, revealing that pregnant women who underwent the more expanded panel had a significantly higher level of perceived risk for the fetus than that reported by pregnant women who underwent the basic one. There was no statistically significant difference between the other psychological variables and NIPT type. CONCLUSIONS: Our findings indicate the paramount role of gynecologist and other health care providers, such as geneticists and psychologists, is to support decision-making process in NIPT, in order to overcome people's deficits in genetic knowledge, promote awareness about their preferences, and control anxiety related to the unborn child. Decision-support strategies are critical during the onset of prenatal care, according to the advances in prenatal genomics and to parent's needs.

Caregiving and Shared Decision Making in Breast and Prostate Cancer Patients: A Systematic Review.

BACKGROUND: A cancer diagnosis can impact patients' and caregivers' lives, posing different challenging situations. In particular, breast cancer and prostate cancer are two types of cancer involving families and especially spouses in challenges linked with the diagnosis and treatment process. Caregivers are usually involved in the treatment decision-making (TDM) process concerning patients' clinical pathway, cancer treatment, and ongoing therapies. To date, no contributions provide an exhaustive overview of the role of caregivers in cancer care and their involvement in the TDM process related to the therapies. METHODS: We performed a systematic review of caregiver and patients experiences and perceptions of caregiver involvement in cancer TDM. Articles were searched on Public/Publisher MEDLINE (PubMed), Excerpta Medica Database (Embase), Medical Literature Analysis and Retrieval System Online (Medline), and American Psychological Association APA PsycINFO. RESULTS: 17 studies were included, 10 on prostate cancer and 7 on breast cancer. According to the reviewed studies, patients and caregivers experienced the cancer diagnosis with a sense of unity. Most patients preferred to have an active or collaborative role with caregivers in TDM, feeling it was important to consult or share the decision made with their caregivers. Caregivers preferred to collaborate with patients or let patients decide by themselves after considering their opinions. Caregiver involvement could have a positive influence on the patient's medical decisions, even if cancer diagnosis and treatments overwhelmed patients and caregivers. CONCLUSIONS: These findings highlight the importance of using a perspective that focuses on the relationship between a patient and caregivers when they receive a cancer diagnosis and have to make a treatment decision. Targeting caregiver-patient dyads, rather than individuals, is important since a supported relationship could have a protective effect on psychological distress, quality of life (QOL), and relationship satisfaction. Moreover, dyads may benefit from interventions that focus on the needs of both the patient and caregiver.

The role of caregivers in the clinical pathway of patients newly diagnosed with breast and prostate cancer: A study protocol.

Background: Caregivers may play a fundamental role in the clinical pathway of cancer patients. They provide emotional, informational, and functional support as well as practical assistance, and they might help mediate the interaction and communication with the oncologists when care options are discussed, or decisions are made. Little is known about the impact of dyadic dynamics on patient-doctor communication, patient's satisfaction, or adherence to the therapies. This study protocol aims to evaluate the efficacy of a psychological support intervention on patients-caregivers relationship and their alignment in the treatment decision-making (TDM) process and estimate related improvement in patient' compliance/adherence to treatments. Methods: A total of 102 patients-caregivers' dyads will be involved, among breast and prostate cancer patients. The study entails a pre- post- evaluation through psychological questionnaires, with a randomization of participants in two conditions, the experimental one in which subjects participate in a psychological support consultation, and the control one, where dyads do not receive any intervention. A follow up after 6 months from the enrollment is planned. Discussion: A positive impact of the psychological support intervention on patients' anxiety, depression, distress, and perceived social support is expected. Such improvements can directly affect patients' satisfaction and adherence to treatments. Data gathered from this study may inform health care providers, policy makers, and public health managers about the importance of caregiver's involvement in the cancer care pathway, and the best way to manage it. A further impact is to develop a specific intervention protocol to support caregivers' involvement in cancer care pathway, improve patient's wellbeing, the interaction with physicians and the compliance with the cancer treatment.

Regulation strategies during COVID-19 quarantine: The mediating effect of worry on the links between coping strategies and anxiety.

Introduction: The COVID-19 outbreak forced Italian citizens into a generalized quarantine from March to May 2020. The quarantine is a successful measure to reduce the virus's spread through physical and social distancing, but it can also have negative psychological consequences on the population. People experience high levels of worry and anxiety and have to cope with the consequences of the health emergency. The aim of this study was to preliminarily assess the causal relations among coping, worry and state anxiety at the time of COVID-19 first wave, and the mediation role of worry between coping and state anxiety. Methods: During March 2020, 1273 Italian citizens completed an ad hoc online survey composed of sociodemographic and preoccupation-related questions, and standardized self-report questionnaire (Brief COPE, Penn State Worry Questionnaire and State-Trait Anxiety Inventory-State form). Three separate mediation models were performed. Results: The relationship between coping strategies (i.e.: problem-focused coping, emotion-focused coping and dysfunctional coping) and state anxiety resulted to be mediated by worry. Dysfunctional and problem-focused coping had a negative effect on anxiety scores and this effect was amplified by high levels of worry. Emotion-focused coping reduced state anxiety scores through its effect on reducing the levels of worry, which in turn was related to a reduction in anxiety. Conclusion: The present study offers first evidence for the mediation role of worry in the relation between coping and anxiety during quarantine caused by COVID-19 pandemic. It supports the clinical importance of investigating people's coping strategies along with the levels of (cognitive) worry and their long-term effects on the psychological well-being during the outbreak, in order to deliver adequate personalized interventions. Psychological support should enhance emotion-focused coping strategies that have a protective effect on both worry and anxiety.

Introduction: L'épidémie de COVID-19 a contraint les citoyens italiens à une quarantaine généralisée de mars à mai 2020. La quarantaine est une mesure efficace pour réduire la propagation du virus grâce à l'éloignement physique et social, mais elle peut également avoir des conséquences psychologiques négatives sur la population. Les gens éprouvent des niveaux élevés d'inquiétude et d'anxiété et doivent faire face aux conséquences de l'urgence sanitaire. Le but de cette étude a été d'évaluer de manière préliminaire les relations causales entre l'adaptation, l'inquiétude et l'anxiété d'état au moment de la première vague de COVID-19, et le rôle médiateur de l'inquiétude entre l'adaptation et l'anxiété d'état. Méthodes: Au cours du mois de mars 2020, 1273 citoyens italiens ont rempli une enquête ad hoc en ligne composée de questions concernant des données socio-démographiques et liées aux préoccupations, et d'un questionnaire d'auto-évaluation standardisé (Brief COPE, Penn State Worry Questionnaire et State-Trait Anxiety Inventory, l'échelle d'anxiété ­ État). Trois modèles de médiation distincts ont été réalisés. Résultats: La relation entre les stratégies d'adaptation (c'est-à-dire l'adaptation centrée sur le problème, l'adaptation centrée sur les émotions et l'adaptation dysfonctionnelle) et l'anxiété liée à l'état a été influencée par l'inquiétude. L'adaptation dysfonctionnelle et axée sur les problèmes a eu un effet négatif sur les scores d'anxiété et cet effet a été amplifié par des niveaux élevés d'inquiétude. L'adaptation axée sur les émotions a réduit les scores d'anxiété d'état par son effet sur la réduction des niveaux d'inquiétude, qui à son tour était liée à une réduction de l'anxiété. Conclusion: La présente étude offre une première preuve du rôle médiateur de l'inquiétude dans la relation entre l'adaptation et l'anxiété pendant la quarantaine causée par la pandémie de COVID-19. Elle soutient l'importance clinique d'étudier les stratégies d'adaptation des personnes ainsi que les niveaux d'inquiétude (cognitive) et leurs effets à long terme sur le bien-être psychologique pendant l'épidémie, afin de fournir des interventions personnalisées adéquates. Le soutien psychologique devrait améliorer les stratégies d'adaptation axées sur les émotions qui ont un effet protecteur sur l'inquiétude et l'anxiété.

The Burden of the Pain: Adverse Mental Health Outcomes of COVID-19 in Women With and Without Cancer.

The coronavirus disease 2019 (COVID-19) pandemic had a negative psychological impact on the population at scale, yet it is possible that vulnerable patient populations may experience a heavier burden with increased feelings of anxiety and distress. Cancer patients have to trade-off between the fear of exposing themselves to the virus and the need to continue life-saving medical procedures. The present study investigated the prevalence of generalized anxiety and post-traumatic stress symptoms (PTSS) in a population of Italian cancer patients and healthy participants in the months following the COVID-19 outbreak. Using standardized measures of PTSS (impact of event scale revised; IES-R) and generalized anxiety (generalized anxiety scale; GAD-7), we found that patients experienced higher levels of adverse mental health outcomes. Several variables were found to negatively affect PTSS and anxiety in this population, including the younger age of respondents, having children, and the impossibility to attend regular medical check-ups. These findings stress the importance of maintaining a clear and regular communication with patients throughout future waves of the pandemic and ensure continuity of care in this vulnerable population. Furthermore, this study indicates the need to establish psychological interventions aimed at patients with cancer, targeting especially younger generations who are more likely to experience adverse psychological outcomes.

Genetic testing users in Italy and Germany: Health orientation, health-related habits, and psychological profile.

BACKGROUND: Rapid advances in genomic knowledge and widespread access to the web contributed to the development of genetic services by private companies or medical laboratories. In the European landscape, though, there is not a single coherent regulatory approach to genetic testing (GT). The study aimed to investigate differences and similarities between two populations of GT users, Italians and Germans, in terms of health-related behaviors, psychological characteristics, and attitudes toward genetic information. METHODS: Ninety-nine Italian GT users from one private genetic company and 64 Germans GT users from one medical laboratory, completed an ad hoc self-administered questionnaire. RESULTS: Results showed significant differences in health-related behaviors (unhealthy eating behaviors, smoking behaviors, and frequency in medical check-ups), with Germans reporting higher levels of unhealthy eating habits and smoking behaviors than Italians; Italian users also were more medically controlled. Furthermore, German participants were less willing to change their lifestyle following the GT results compared to Italian participants. Regarding psychological variables, German users felt more confident about their physical well-being and they seemed more motivated than Italians to avoid becoming unhealthy. Finally, two samples differed in the way they accessed genetic testing (with the Italians guided predominately by a physician in contrast with the Germans who were recommended by friends) and managed genetic testing results (with Italian participants significantly more willing to share results with doctors than German participants, who preferred sharing with the family). CONCLUSION: The analysis of cultural and organizational differences could help in defining adequate guidelines for counseling, and provide inputs for regulators in different European contexts.

What people really change after genetic testing (GT) performed in private labs: results from an Italian study.

Despite the widespread diffusion of direct-to-consumer genetic testing (GT), it is still unclear whether people who learn about their genetic susceptibility to a clinical condition change their behaviors, and the psychological factors involved. The aim of the present study is to investigate long-term changes in health-related choices, individual tendencies and risk attitudes in an Italian sample of GT users. In the context of the Mind the Risk study, which investigated a sample of Italian adults who underwent GT in a private laboratory, 99 clients participated in the follow up assessment. They completed a self-administered questionnaire investigating: (a) clinical history and motivation for testing, (b) lifestyle and risk behaviors, (c) individual tendencies toward health, and (d) risk-taking attitude and risk tolerance. Such variables were measured at three different time-points: T0-before GT, T1-at 6 months after genetic results, and T2-at 1 year from results. Results showed that, at baseline, participants who stated they intended to modify their behavior after GT results, effectively did so over time. This result held both for participants who received a positive or negative test result. In general, a healthier diet was the most frequently observed long-term behavioral change. As regards psychological variables, a risk-taking attitude and risk tolerance did not seem to affect the decision to change the lifestyle. Finally, we found an overall reduction in anxiety and worry over health over time, but also a reduction in the motivation for health promotion and prevention, health esteem, and positive expectations for their health in the future.

Opportunities and Challenges of Web-Based and Remotely Administered Surveys for Patient Preference Studies in a Vulnerable Population.

The application of web-based and remotely administered surveys is becoming increasingly popular due to the fact that it offers numerous advantages over traditional paper-based or computer-based surveys completed in the presence of the researcher. However, it is unclear whether complex preference elicitation tasks administered online in highly vulnerable patient populations are also feasible. This commentary discusses opportunities and challenges of conducting quantitative patient preference studies in lung cancer patients using web-based modes of data collection. We refer to our recent experience in the context of the Patient Preference in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project. Among the main advantages were the possibility of reaching a wider and geographically distant population in a shorter timeframe while reducing the financial costs of testing, the greater flexibility offered and the reduced burden on the patients. Some limitations were also identified and should be the object of further research, including the potential lack of inclusiveness of the research, the lack of control over who is completing the survey, a poor comprehension of the study material, and ultimately a lower level of engagement with the study. Despite these limitations, experience from the PREFER project suggests that online quantitative methods for data collection may provide a valuable method to explore preferences in vulnerable patient populations beyond the COVID-19 pandemic.

Key Determinants of Health-Related Quality of Life Among Advanced Lung Cancer Patients: A Qualitative Study in Belgium and Italy.

Background: The lung cancer (LC) treatment landscape has drastically expanded with the arrival of immunotherapy and targeted therapy. This new variety of treatment options, each with its own characteristics, raises uncertainty regarding the key aspects affecting patients' health-related quality of life (HRQL). The present qualitative study aimed to investigate how LC patients perceive their HRQL and the factors that they consider to be most influential in determining their HRQL. Methods: This qualitative research incorporates four focus group discussions, with six LC patients in each group. In total, 24 stage III and IV LC patients were included in the discussions, with Italian (n = 12) and Belgian (n = 12) patients, age range: 42-78, median age = 62 (IQR = 9.3 years), SD = 8.5; 62% men. Using thematic analysis, transcripts and notes from the FGDs were analyzed using NVivo software (edition 12). Results: Three main themes capturing determinants of HRQL were identified. First, patients agreed on the importance of physical aspects (symptoms and side-effects) in determining their HRQL. In particular, skin conditions, nausea, fatigue, risk of infections, sensory abnormalities, pain, and changes in physical appearance were highlighted. Second, patients worried about psychological aspects, negatively impacting their wellbeing such as uncertainties regarding their future health state, and a lower degree of autonomy and independence. Third, patients underlined the importance of social aspects, such as communication with healthcare providers and social interaction with friends, family and peers. Conclusion: This study demonstrates that physical, psychological, and social aspects are key factors driving LC patients' HRQL. Gaining a better understanding of how LC patients perceive their HRQL and how it is affected by their illness and therapy will aid patient-centric decision-making across the drug life cycle, by providing stakeholders (drug developers, regulators, reimbursement bodies, and clinicians) insights about the treatment and disease aspects of importance to LC patients as well as the unmet needs LC patients may have regarding available treatment modalities. Finally, this study underscores a need for individual treatment decision-making that is considerate of uncertainties among LC patients about their future health state, and ways for improving communication between healthcare providers and patients to do so.

Patient Preferences for Lung Cancer Treatments: A Study Protocol for a Preference Survey Using Discrete Choice Experiment and Swing Weighting.

Background: Advanced treatment options for non-small cell lung cancer (NSCLC) consist of immunotherapy, chemotherapy, or a combination of both. Decisions surrounding NSCLC can be considered as preference-sensitive because multiple treatments exist that vary in terms of mode of administration, treatment schedules, and benefit-risk profiles. As part of the IMI PREFER project, we developed a protocol for an online preference survey for NSCLC patients exploring differences in preferences according to patient characteristics (preference heterogeneity). Moreover, this study will evaluate and compare the use of two different preference elicitation methods, the discrete choice experiment (DCE) and the swing weighting (SW) task. Finally, the study explores how demographic (i.e., age, gender, and educational level) and clinical (i.e., cancer stage and line of treatment) information, health literacy, health locus of control, and quality of life may influence or explain patient preferences and the usefulness of a digital interactive tool in providing information on preference elicitation tasks according to patients. Methods: An online survey will be implemented with the aim to recruit 510 NSCLC patients in Belgium and Italy. Participants will be randomized 50:50 to first receive either the DCE or the SW. The survey will also collect information on participants' disease-related status, health locus of control, health literacy, quality of life, and perception of the educational tool. Discussion: This protocol outlines methodological and practical steps to quantitatively elicit and study patient preferences for NSCLC treatment alternatives. Results from this study will increase the understanding of which treatment aspects are most valued by NSCLC patients to inform decision-making in drug development, regulatory approval, and reimbursement. Methodologically, the comparison between the DCE and the SW task will be valuable to gain information on how these preference methods perform against each other in eliciting patient preferences. Overall, this protocol may assist researchers, drug developers, and decision-makers in designing quantitative patient preferences into decision-making along the medical product life cycle.

Incidence of PTSD and generalized anxiety symptoms during the first wave of COVID-19 outbreak: an exploratory study of a large sample of the Italian population.

BACKGROUND: During the COVID-19 pandemic, between March and May 2020, in Italy, people were asked to shelter in place and most had to put their life on hold, while news of the spread of the virus constantly were broadcasted. The change in habits and the potential exposure to a dangerous virus can be categorized as a catastrophic event, which are usually traumatic and therefore have psychological consequences for the people involved. OBJECTIVE: Assuming the COVID-19 pandemic as a possible traumatic event, this study aims to explore the contingent behavioural and psychological impact of COVID-19 spread and related lockdown on the Italian general population, through measuring anxiety and post-traumatic stress symptoms . METHODS: An ad hoc-survey was set up for the this exploratory research, including the standardized Italian versions of the Impact of Event Scale Revised (IES-R) and the Generalized Anxiety Scale (GAD-7), and ad hoc items concerning behavioural reactions due to the pandemic spread and related mass quarantine. Participants were recruited across convenient web-based and mobile app channels using a snowball sampling technique. Data was collected from March 25th to May 1st, 2020. PARTICIPANTS: One-thousand one hundred and ninety-five individuals (851 women and 342 men) completed 60% or more of the survey and were considered for analyses. Mean age was 40 years (s.d. = 14.948). Participants resided in 78 Italian provinces (out of 107 territorial divisions), with 25.7% residing in the Milan province and 9.2% from the Monza and Brianza provinces, closest to the epicentre of the Italian outbreak. RESULTS: During the worst months of the first wave of the Pandemic, the Italian population suffered high level of distress (GAD-7 m = 6.89, s.d. = 5.08; IER-R mean score = 27.86, s.d. 17.46), respectively indicating mild presence of anxiety symptoms, and high levels of PTSD symptoms. Gender seems to be a discriminating variable with women scoring significantly higher than man, both for anxiety symptoms (H (1) = 82.91, p < .001) and all dimensions of PTSD symptoms (intrusion H (1) = 71.23, p < .001, avoidance H (1) = 61.28, p < .001), and hyperarousal (H (1) = 67.348, p < .001). People from Generations Y and Z show to be at higher risk of developing PTSD (V = .746, F (3,1041) =1017.19, p = .001) and GAD symptoms (F (3,1041) = 5.113, p = .002) than older generations. CONCLUSIONS: Gender and generation appeared to be the most consistent risk factor for higher levels of generalized anxiety and PTSD symptoms in the current pandemic. Other variables - such as information seeking behaviours, parental and marriage status, chronic conditions - yielded less consistent evidence. Results indicate the need of including psychological interventions as a standard tool during the emergency management of a catastrophic events such as a pandemic.

Should oncoplastic breast conserving surgery be used for the treatment of early stage breast cancer? Using the GRADE approach for development of clinical recommendations.

INTRODUCTION: The potential advantages of oncoplastic breast conserving surgery (BCS) have not been validated in robust studies that constitute high levels of evidence, despite oncoplastic techniques being widely adopted around the globe. There is hence the need to define the precise role of oncoplastic BCS in the treatment of early breast cancer, with consensual recommendations for clinical practice. METHODS: A panel of world-renowned breast specialists was convened to evaluate evidence, express personal viewpoints and establish recommendations for the use of oncoplastic BCS as primary treatment of unifocal early stage breast cancers using the GRADE approach. RESULTS: According to the results of the systematic review of literature, the panelists were asked to comment on the recommendation for use of oncoplastic BCS for treatment of operable breast cancer that is suitable for breast conserving surgery, with the GRADE approach. Based on the voting outcome, the following recommendation emerged as a consensus statement: Oncoplastic breast conserving surgery should be recommended versus standard breast conserving surgery for the treatment of operable breast cancer in adult women who are suitable candidates for breast conserving surgery (with very low certainty of evidence). DISCUSSION: This review has revealed a low level of evidence for most of the important outcomes in oncoplastic surgery with lack of any randomized data and absence of standard tools for evaluation of clinical outcomes and especially patients' values. Despite areas of controversy, about one-third (36%) of panel members expressed a strong recommendation in support of oncoplastic BCS. Presumably, this reflects a synthesis of views on the relative complexity of these techniques, associated complications, impact on quality of life and costs.

What Matters Most to Lung Cancer Patients? A Qualitative Study in Italy and Belgium to Investigate Patient Preferences.

Background: The potential value of patient preference studies has been recognized in clinical individual treatment decision-making between clinicians and patients, as well as in upstream drug decision-making. Drug developers, regulators, reimbursement and Health Technology Assessment (HTA) bodies are exploring how the use of patient preference studies could inform drug development, regulatory benefit risk-assessment and reimbursement decisions respectively. Understanding patient preferences may be especially valuable in decisions regarding Non-Small Cell Lung Cancer (NSCLC) treatment options, where a variety of treatment options with different characteristics raise uncertainty about which features are most important to NSCLC patients. As part of the Innovative Medicines Initiative PREFER project, this qualitative study aimed to identify patient-relevant lung cancer treatment characteristics. Methods: This study consisted of a scoping literature review and four focus group discussions, 2 in Italy and 2 in Belgium, with a total of 24 NSCLC patients (Stages III-IV). The focus group discussions sought to identify which treatment characteristics patients find most relevant. The discussions were analyzed thematically using a thematic inductive analysis. Results: Patients highlighted themes reflecting: 1) positive effects or expected gains from treatment such as greater life expectancy and maintenance of daily functioning, 2) negative effects or adverse events related to therapy that negatively impact patients' daily functioning such as fatigue and 3) uncertainty regarding the duration and type of treatment effects. These overarching themes were consistent among patients from Belgium and Italy, suggesting that treatment aspects related to efficacy and safety as well as the psychological impact of lung cancer treatment are common areas of concern for patients, regardless of cultural background or country. Discussion: Our findings illustrate the value of using qualitative methods with patients to identify preferred treatment characteristics for advanced lung cancer. These could inform a subsequent quantitative preference survey that assesses patient trade-offs regarding treatment options.

Exploring public attitude toward biofeedback technologies: Knowledge, preferences and personality tendencies.

Background: Biofeedback is increasingly used in the clinical area and in daily health monitoring through wearable devices (e.g. smart watches). Nevertheless, it remains rather unknown. This study aimed to assess, in a sample of Italian citizens, the level of knowledge, attitudes, perceived efficacy and personality tendencies which could affect the uptake of biofeedback technologies. Design and Methods: Participants were recruited by advertising the survey on the social networks, from March to May 2019. 160 subjects filled in an ad hoc online questionnaire assessing socio-demographic variables, clinical status, physical activity, knowledge and attitude towards biofeedback, psychological tendencies toward health. Results: Data showed a good level of interest in biofeedback training in spite of poor knowledge about such technologies. Sport and chronic diseases were not correlated to a greater use of biofeedback. People informed about biofeedback technologies were more interested in undergoing biofeedback training and had higher scores in the Health Locus of Control. Finally, people who showed a positive perception of their own health (Health Esteem) did not rely on these technologies. Discussion: Despite the huge spread of biofeedback technologies, our results disconfirmed the expectation that people having an active lifestyle or a disease were more familiar with biofeedback systems. The attitude toward such technologies seems to depend on individual tendencies. Conclusions: This study suggests the importance to improve general public literacy on biofeedback technologies, tailor tools on their needs and characteristics, empower people's sense of internal health control for promoting a valid use and a proper knowledge of biofeedback.