What leads healthy people to enter in a volunteer register for clinical trials? This study aimed to investigate the relationship between the decision to volunteer in clinical trials for a COVID-19 ...vaccine and social capital, in a sample of healthy volunteers in Italy. Since social capital is characterized by trust, reciprocity, and social and political participation, we claim that it is key in leading individuals to actively take action to protect public health, and to take a risk for the (potential) benefit not only of themselves but for the entire community.
This study was conducted through the administration of a questionnaire to healthy volunteers registered for a phase 1 clinical trial for a COVID-19 vaccine in the Unit Research Centre of ASST-Monza, in September 2020. The primary purpose of a phase 1 study is to evaluate the safety of a new drug candidate before it proceeds to further clinical studies. To approximate a case-control study, we randomly matched the 318 respondents to healthy volunteers (cases) with 318 people randomly selected by Round 9 of the European Social Survey (controls), using three variables, which we considered to be associated with the decision to volunteer: gender, age, and education level. To execute this matching procedure, we used the "ccmatch" module in STATA.
The findings highlight the positive impact of social capital in the choice of healthy individuals to volunteer in COVID-19 vaccine clinical trials. Controlling for possible confounding factors, some exemplary results show that people with a high level of general trust have a greater likelihood of volunteering compared to people with low trust (OR = 2.75, CI = 1.58-4.77); we also found that it is more probable that volunteers are people who have actively taken action to improve things compared with people who have not (for individuals who did three or more actions: OR = 7.54, CI = 4.10-13.86). People who reported voting (OR = 3.91, CI = 1.70-8.99) and participating in social activities more than other people of their age (OR = 2.89, CI = 1.82-4.60) showed a higher probability to volunteer.
Together with the adoption of urgent health measures in response to COVID-19, government policymakers should also promote social capital initiatives to encourage individuals to actively engage in actions aimed at protecting collective health. Our findings make an empirical contribution to the research on vaccines and its intersection with social behaviour, and they provide useful insights for policymakers to manage current and future disease outbreaks and to enhance the enrolment in vaccine trials.
Background: Assessing medically-related fears is of paramount importance to foster medical positive experiences and outcomes and requires an easy-to-administer tool. The Medical Fear Survey-Short ...Version (MFS-SV) is a 25-item questionnaire assessing 5 medically related fears (Injections and Blood Draws, Sharp Objects, Blood, Mutilation, and Examinations and Symptoms). Methods: To examine the psychometric properties of the Italian version of the MFS-SV, exploratory and confirmatory factor analysis were performed on data from 1010 young adults (68.8% female, mean age= 23.9±5.05) who provided demographic information and completed the MFS-SV, the Padua Inventory-Contamination Fear Subscale, the Disgust Propensity and Sensitivity Scale revised (DPSS-R) and the Injection Phobia Scale-Anxiety (IPS-Anx). Convergent validity, reliability, test-retest stability, and multigroup invariance were assessed. Discriminant analysis explored the potential screening function of the MFS-SV. Results: The 5-factor structure of the questionnaire was confirmed, explaining the 68.8% of variance. Raykov’s composite reliability coefficients ranged between .84 and .95. Test-retest stability, convergent validity, and the consistency of the scores across gender were confirmed. The MFS-SV could discriminate subjects with a history of blood donations (Wilk’s Lambda = 0.915; p 0.001). Conclusion: The overall results supported the psychometric properties of the MFS-SV and its suitability for both research and clinical uses to assess different medical fears.
Background
Patient preferences (PP), which are investigated in PP studies using qualitative or quantitative methods, are a growing area of interest to the following stakeholders involved in the ...medical product lifecycle: academics, health technology assessment bodies, payers, industry, patients, physicians, and regulators. However, the use of PP in decisions along the medical product lifecycle remains limited. As the adoption of PP heavily relies on these stakeholders, knowledge of their perceptions of PP is critical.
Objective
This study aimed to characterize stakeholders’ attitudes, needs, and concerns with respect to PP in decision making along the medical product lifecycle.
Methods
Semi-structured interviews (
n
= 143) were conducted with academics (
n
= 24), health technology assessment/payer representatives (
n
= 24), industry representatives (
n
= 24), patients, caregivers and patient representatives (
n
= 24), physicians (
n
= 24), and regulators (
n
= 23) from seven European countries and the USA. Interviews were conducted between April and August 2017. The framework method was used to organize the data and identify themes and key findings in each interviewed stakeholder group.
Results
Interviewees reported being unfamiliar (43%), moderately familiar (42%), or very familiar (15%) with preference methods and studies. Interviewees across stakeholder groups generally supported the idea of using PP in the medical product lifecycle but expressed mixed opinions about the feasibility and impact of using PP in decision making. Interviewees from all stakeholder groups stressed the importance of increasing stakeholders’ understanding of the concept of PP and preference methods and ensuring patients’ understanding of the questions asked in PP studies. Key concerns and needs in each interviewed stakeholder group were as follows: (1) academics: investigating the validity, reliability, reproducibility, and generalizability of preference methods; (2) health technology assessment/payer representatives: developing quality criteria for evaluating PP studies and gaining insights into how to weigh them in reimbursement/payer decision making; (3) industry representatives: obtaining guidance on PP studies and recognition on the importance of PP from decision makers; (4) patients, caregivers, and patient representatives: providing an incentive and adequate information towards patients when participating in PP studies; (5) physicians: avoiding bias as a result of commercial agendas in PP studies and clarifying how to deal with subjective and emotional elements when measuring PP; and (6) regulators: avoiding the misuse of PP study results to overrule the traditional efficacy and safety criteria used for marketing authorization and obtaining robust PP study results.
Conclusions
Despite the interest all interviewed stakeholder groups reported in PP, the effective use of PP in decision making across the medical product lifecycle is currently hampered by a lack of standardization and consensus on how to both measure and use PP.
Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in ...assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders.
Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software.
Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients’ ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations).
Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.
The use of mobile health (mHealth) apps in clinical settings is increasing widely. mHealth has been used to promote prevention, improve early detection, manage care, and support survivors and chronic ...patients. However, data on the efficacy and utility of mHealth apps are limited.
The main objective of this review was to provide an overview of the available research-tested interventions using mHealth apps and their impact on breast cancer care.
A systematic search of Medline, PsycINFO, Embase, and Scopus was performed to identify relevant studies. From the selected studies, the following information was extracted: authors, publication date, study objectives, study population, study design, interventions' features, outcome measures, and results.
We identified 29 empirical studies that described a health care intervention using an mHealth app in breast cancer care. Of these, 7 studies were about the use of an mHealth application in an intervention for breast cancer prevention and early detection, 12 targeted care management, and 10 focused on breast cancer survivors.
Our results indicate consistent and promising findings of interventions using mHealth apps that target care management in breast cancer. Among the categories of mHealth apps focusing on survivorship, mHealth-based interventions showed a positive effect by promoting weight loss, improving the quality of life, and decreasing stress. There is conflicting and less conclusive data on the effect of mHealth apps on psychological dimensions. We advocate further investigation to confirm and strengthen these findings. No consistent evidence for the impact of interventions using mHealth apps in breast cancer prevention and early detection was identified due to the limited number of studies identified by our search. Future research should continue to explore the impact of mHealth apps on breast cancer care to build on these initial recommendations.
The widespread use of online search engines to answer the general public’s needs for information has raised concerns about possible biases and the emerging of a ‘filter bubble’ in which users are ...isolated from attitude-discordant messages. Research is split between approaches that largely focus on the intrinsic limitations of search engines and approaches that investigate user search behavior. This work evaluates the findings and limitations of both approaches and advances a theoretical framework for empirical investigations of cognitive biases in online search activities about health-related topics. We aim to investigate the interaction between the user and the search engine as a whole. Online search activity about health-related topics is considered as a hypothesis-testing process. Two questions emerge: whether the retrieved information provided by the search engines are fit to fulfill their role as evidence, and whether the use of this information by users is cognitively and epistemologically valid and unbiased.
After the COVID-19 pandemic outbreak in March 2020, the majority of hospital policies have followed guidelines aimed to prevent the virus transmission and the families' entry was denied in all ...hospital wards and intensive care units (ICU). Despite being necessary, such restrictions have been experienced with discomfort and sufferings by the general ICU staff of Treviso Hospital (Italy) and by families of patients. Therefore, from April 2020, a step-by-step project was developed to reactivate contact with COVID-19 patients' families. The several requests and appeals of intensive care communities and organizations, both nationally and internationally, motivated the Treviso hospital initiative, leading to a model that might be potentially useful to other intensive care units worldwide.
Major recent interpretations of the conjunction fallacy postulate that people assess the probability of a conjunction according to (non-normative) averaging rules as applied to the constituents' ...probabilities or represent the conjunction fallacy as an effect of random error in the judgment process. In the present contribution, we contrast such accounts with a different reading of the phenomenon based on the notion of inductive confirmation as defined by contemporary Bayesian theorists. Averaging rule hypotheses along with the random error model and many other existing proposals are shown to all imply that conjunction fallacy rates would rise as the perceived probability of the added conjunct does. By contrast, our account predicts that the conjunction fallacy depends on the added conjunct being perceived as inductively confirmed. Four studies are reported in which the judged probability versus confirmation of the added conjunct have been systematically manipulated and dissociated. The results consistently favor a confirmation-theoretic account of the conjunction fallacy against competing views. Our proposal is also discussed in connection with related issues in the study of human inductive reasoning.
Recent estimates suggest that up to 34% of frontline workers in healthcare (FLWs) at the forefront of the COVID-19 pandemic response are reporting elevated symptoms of psychological distress due to ...resource constraints, ineffective treatments, and concerns about self-contamination. However, little systematic research has been carried out to assess the mental health needs of FLWs in Europe, or the extent of psychological suffering in FLWs within different European countries of varying outbreak severity. Accordingly, this project will employ a mixed-methods approach over three work packages to develop best-practice guidelines for alleviating psychological distress in FLWs during the different phases of the pandemic. Work package 1 will identify the point and long-term prevalence of psychological distress symptoms in a sample of Irish and Italian FLWs, and the predictors of these symptoms. Work package 2 will perform a qualitative needs assessment on a sample of Irish and Italian FLWs to identify sources of stress and resilience, barriers to psychological care, and optimal strategies for alleviating psychological distress in relation to the COVID-19 pandemic. Work package 3 will synthesise the findings from the preceding work packages to draft best practice guidelines, which will be co-created by a multidisciplinary panel of experts using the Delphi method. The guidelines will provide clinicians with a framework for alleviating psychological distress in FLWs, with particular relevance to the COVID-19 pandemic, but may also have relevance for future pandemics and other public health emergencies.
This study explored the trajectories of patient-centered orientation in a sample of Italian medical students throughout medical school.
Four consecutive student cohorts were longitudinally assessed ...at the second (T0) and fifth year (T1) of medical school. Students completed a questionnaire including demographics and the Italian validated version of the Patient-Practitioner Orientation Scale.
352 students completed both administrations. Students became more patient-centered in terms of Sharing along the course of their clinical curriculum, whereas there were no significant changes in Caring. Groups with distinct developmental trajectory patterns of both Caring and Sharing were identified. Students high in patient-centeredness at T0 reported significantly lower scores at T1 while students with lower scores at T0 significantly increased from the first to the last measurement. Female students significantly outscored their male colleagues on Caring and Sharing in both administrations.
Findings call for innovative education strategies to sustain patient-centeredness attitudes in medical students entering hospital-based clinical medicine. Further research is needed to identify characteristics of the medical curriculum that are primarily involved in fostering students’ patient-centeredness.
Including the assessment and monitoring of patient-centeredness throughout the medical school can inform tailored education aiming to foster this dimension.
•Sharing attitude increased throughout medical school while Caring remained stable.•Students scoring lower on Caring and Sharing in year 2 increased in year 5.•Students scoring higher on Caring and Sharing in year 2 decreased in year 5.•Females students were more patient-centered than their male counterparts.
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