Search

Iron deficiency anaemia (IDA) is the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD). The Health Technology Assessment approach was applied to evaluate the sustainability of intravenous (IV) iron formulations in the Italian hospital setting, with particular focus on ferric carboxymaltose. Data on the epidemiology of IBD and associated IDA, in addition to the efficacy and safety of IV iron formulations currently used in Italy, were retrieved from scientific literature. A hospital-based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed. IDA prevalence in IBD patients varies markedly from 9 to 73%. IV iron preparations were proven to have good efficacy and safety profiles, and ferric carboxymaltose provided a fast correction of haemoglobin and serum ferritin levels in iron-deficient patients. Despite a higher price, ferric carboxymaltose would confer a beneficial effect to the hospital, in terms of reduced cost related to individual patient management and additionally to the patient by reducing the number of infusions and admissions to healthcare facilities. Ethically, the evaluation is appropriate due to its efficacy and compliance. This assessment supports the introduction of ferric carboxymaltose in the Italian outpatient setting. [ABSTRACT FROM AUTHOR]

The first panellist will focus on the jurists view on the legislative proposal on DCC, discuss proportionality of measure, incl. key considerations for DCC and PLF data combinations. A basic overview on the differences between vaccination, certificates, immunity passports and other passes, and the key characteristics of the DCC will be provided. Feasibility in terms of implementing acts across EU Member- States will be elaborated upon, incl. both potential expiry and revocation, as well as potential remedies in case of emerging issues, i.e., right to DCC, but no vaccine, strong contraindication against vaccination, known issues of reduced immunity despite vaccination, etc. Critical aspects with relevance for both the European and the global dimensions, i.e., GDPR and data transfer agreements, secondary use of health data, human-rights’ issues, implications for vulnerable groups, etc., will also be discussed. [ABSTRACT FROM AUTHOR]

Caramaschi F [Istituto di Igiene Università di Padova, Via Loredan 18, 35100 Padova, Italy], Del Corno G, Favaretti C, Giambelluca SE, Montesarchio E and Fara GM. Chloracne following environmental contamination by TCDD in Seveso, Italy. 1981, 10: 135–143. Data are presented on the occurrence of chloracne, clinical symptoms and biochemical changes in 164 children following environmental contamination by TCDD from an industrial accident in Seveso, Italy. An overall positive association was found between the territorial distribution of chloracne cases and the different levels of soil contamination in the affected area. Individual risk factors such as condition and length of exposure, intake via contaminated foods, etc. were evaluated; no single factor appeared to be associated with chloracne. Disturbances of the gastrointestinal tract were more frequently observed in children affected with chloracne than in those from the same areas having no skin lesions. However, no clinically definable systemic disease has been diagnosed. [ABSTRACT FROM PUBLISHER]

A three-year oncology teleconsulting project was concluded in November 2000. During a six-month study period, 38 clinical physicians and 47 nurses used the system. A total of 617 electronic patient records were created in the oncology department, 297 in dermatology and 24 in gynaecology. There were 45 synchronous teleconsultations involving various participants, lasting a total of 708 min. We conducted surveys of the attitudes of users to the teleconsulting system both before and after its implementation. There were no significant differences between the two surveys and the results showed that users had a positive reaction to the system and high expectations of its future utilization. [ABSTRACT FROM AUTHOR]

Background/Objectives . Many vaccines have been developed in recent decades, and many more will be available in the future. When new safe and effective vaccines are available, decision-makers must extensively assess them before including them in the national immunization plan and issuing recommendations. The Health Technology Assessment (HTA) could be an objective, transparent, and comprehensive approach to guiding the decision-making process for the use of vaccines. Objectives and Methods . The aim of this study was to review the indications for HTA use contained in Italian institutional documents on vaccination, namely the National Immunization Plans (NIPs) and available full Italian HTA reports on vaccines, assessing their availability at the time of national recommendations' introductions. Results . HTA has been recognised as an eligible approach to deciding upon the introduction of vaccines through the NIPs of 2012-2014 and 2017-2019, and the last NIP, of 2023-2025, highlights the lack of funding dedicated to the production of independent HTA reports that can be used for issuing recommendations. In 2007-2023, twenty full HTA reports on vaccines were published in Italy: eight reports on influenza vaccines, five on Human Papilloma Virus (HPV), three each on meningococcal and pneumococcal vaccines, and one on rotavirus vaccine. HTA was applied with different purposes, namely the evaluation of new vaccines or their re-assessment, but it was not always timely with respect to both the marketing authorisation and the issuing of national recommendations for use. Conclusions . As HTA can be considered the best tool to disentangle the overall value of vaccines, it would be desirable for it to be used more and more to provide the evidence for efficient resource use. This calls for action to improve the transfer of HTA results to decision-makers, to try to fill the gap between research and decision and foster evidence-based recommendations.

Background: Individuals with high blood pressure in India often miss essential follow-up visits. Missed visits contribute to gaps across the hypertension care continuum and preventable cardiovascular disease. Widespread misconceptions around hypertension care and treatment may contribute to low follow-up attendance rates, but to date, there is limited evidence of the effect of interventions to debunk such misconceptions on health-seeking behavior. We conducted a randomized controlled trial to measure whether combining information debunking commonly-held misconceptions with a standard reminder reduces missed follow-up visits among individuals with high blood pressure and investigated whether any observed effect was moderated through belief change., Methods: We recruited 388 patients with uncontrolled blood pressure from the outpatient wards of two public sub-district hospitals in Punjab, India. Participants randomly assigned to the intervention arm received two WhatsApp messages, sent 3 and 1 days before their physician-requested follow-up visit. The WhatsApp message began with a standard reminder, reminding participants of their upcoming follow-up visit and its purpose. Following the standard reminder, we included brief debunking statements aimed at acknowledging and correcting common misconceptions and misbeliefs about hypertension care seeking and treatment. Participants in the control group received usual care and did not receive any messages., Results: We did not find evidence that the enhanced WhatsApp reminders improved follow-up visit attendance (Main effect: 2.2 percentage points, p-value = 0.603), which remained low across both treatment (21.8%, 95% CI: 15.7%, 27.9%) and control groups (19.6%, 95% CI: 14.2%, 25.0%). Participants had widespread misconceptions about hypertension care but our debunking messages did not successfully correct these beliefs (p-value = 0.187)., Conclusions: This study re-affirms the challenge of continuity of care for chronic diseases in India and suggests that simple phone-based health communication methods may not suffice for changing prevalent misconceptions and improving health-seeking behavior., Trial Registration: The trial began on July 18th. We registered the trial on July 18th (before recruitment began), including the main outcomes, on the German Clinical Trial Register [Identifier: DRKS00029712] and published a pre-analysis plan in the Open Science Framework [osf.io/67g35]., (© 2024. The Author(s).)

Objectives: The objective was to identify antimicrobial resistance related knowledge, attitudes and practice gaps of general practitioners, patients and farmers., Methods: Cross-sectional, mixed-mode (in-person and distance) survey conducted out among the key antimicrobial prescribers and consumers in Uzbekistan, from March to October 2020. We calculated knowledge and attitude scores and applied multivariable adaptive linear regression., Results: Data were collected from 718 adults (236 - GPs, 251 - patients and 231 - farmers) aged 18 years and older. 66.5 % (n = 157) of general practitioners didn't base their antimicrobials prescription on guidelines. A third were not familiar with the delayed antibiotic prescriptions strategy. Most general practitioners prescribe antibiotics on patients' request; one third if patients have fever, almost 60 % (n = 142) if patients have cough with sputum.Majority of patients believed that antibiotics can cure influenza and cold. Every third farmer thought that antibiotics is an antiviral and every fifth a tool to increase productivity. Almost two third of them used antibiotics to protect livestock/poultry/fish from disease.For all three groups, the strongest predictor for the right attitude was the knowledge level., Conclusions: All three groups had knowledge gaps in the form of misconception and problem underestimation which manifests itself as a wrong practice. Interventions are needed at the national, institutional and individual levels, in particular in the trainings of general practitioners and farmers., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Research team reports financial support was provided by TDR, the 10.13039/100016285Special Programme for Research and Training in Tropical Diseases, co-sponsored by UNICEF, UNDP, the World Bank and WHO. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors.)

Background: The World Health Organization defines "infodemic" as the phenomenon of an uncontrolled spread of information in digital and physical environments during a disease outbreak, causing confusion and risk-taking behaviors that can harm health. The aim of this scoping review is to examine international evidence and identify strategies and bottlenecks to tackle health-related fake news., Methods: We performed a scoping review of the literature from 1 January 2018 to 26 January 2023 on PubMed, Web of Science, and Scopus electronic databases. We also performed a search of grey literature on institutional websites. The research question has been defined according to the PCC (population, concept, and context) mnemonic for constructing research questions in scoping reviews., Results: The overall research in the scientific databases yielded a total of 5,516 records. After removing duplicates, and screening the titles, abstracts, and full texts, we included 21 articles from scientific literature. Moreover, 5 documents were retrieved from institutional websites. Based on their content, we decided to group recommendations and bottlenecks into five different and well-defined areas of intervention, which we called strategies: "foster proper communication through the collaboration between science and social media companies and users," "institutional and regulatory interventions," "check and debunking," "increase health literacy," and "surveillance and monitoring through new digital tools.", Conclusion: The multidisciplinary creation of standardized toolkits that collect recommendations from the literature and institutions can provide a valid solution to limit the infodemic, increasing the health education of both citizens and health professionals, providing the knowledge to recognize fake news, as well as supporting the creation and validation of AI tools aimed at prebunking and debunking., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Gentili, Villani, Osti, Corona, Gris, Zaino, Bonacquisti, De Maio, Solimene, Gualano, Favaretti, Ricciardi and Cascini.)

The COVID-19 pandemic has put a lot of pressure on all the world's health systems and public health leaders who have often found themselves unprepared to handle an emergency of this magnitude. This study aims to bring together published evidence on the qualities required to leaders to deal with a public health issue like the COVID-19 pandemic. This scoping literature review was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist. A search of relevant articles was performed in the PubMed, Scopus and Web of Science databases. A total of 2499 records were screened, and 45 articles were included, from which 93 characteristics of effective leadership were extrapolated and grouped into 6 clusters. The qualities most frequently reported in the articles were human traits and emotional intelligence (46.7%) and communication skills such as transparency and reliability (48.9%). Responsiveness and preparedness (40%), management skills (33.3%) and team working (35.6%) are considered by a significant percentage of the articles as necessary for the construction of rapid and effective measures in response to the emergency. A considerable proportion of articles also highlighted the need for leaders capable of making evidence-based decisions and driving innovation (31.1%). Although identifying leaders who possess all the skills described in this study appears complex, determining the key characteristics of effective public health leadership in a crisis, such as the COVID-19 pandemic, is useful not only in selecting future leaders but also in implementing training and education programmes for the public health workforce., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: A working group conducted a survey on the use of the principle of buffer space (BS), which in case of emergencies, could benefit healthcare settings. The aim of the preliminary investigation is to define new research lines in hospitals' functional design., Background: The global experience of the COVID-19 pandemic highlighted challenges faced by hospitals when responding promptly to emergencies, including spatial reorganization and suspension of ordinary medical activities for ensuring adequate management of the emergency surge of patients., Methods: The group designed questionnaires to be administered to healthcare staff and healthcare designers aimed at understanding varied conceptions and features of BSs. Content across the two surveys overlapped significantly, allowing for direct comparisons of responses, while also including tailored questions in relation to the respective experience and skills of the two groups of respondents., Results: 102 healthcare professionals and 56 designers took part to the survey. Analysis of the responses permitted for initial recommendations regarding BS typology including (a) proximity to the emergency department (ED), intensive care units (ICUs), and inpatient wards (IWs); (b) location within hospitals but separate from other medical areas; (c) need for independent access; (d) organizational and spatial features similar to ED, ICUs, and IWs; (e) existing as a fully flexible operational space; and (f) BS bed capacity to be approximately 12% of ED beds., Conclusions: Although the analysis is related to the Italian context, the expansion of this preliminary research to alternate healthcare facilities and geographic areas is necessary for reaching a wide consensus by different professionals on this field. It serves as a starting point for future investigations regarding the implementation of BS in hospital settings., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Addressing the global challenge of vaccine hesitancy, amplified during the COVID-19 pandemic due to misinformation propagated via social media, necessitates innovative health communication strategies. This investigation scrutinizes the efficacy of Short, Animated, Story-based (SAS) videos in fostering knowledge, behavioral intent, and engagement around COVID-19 vaccination. We conducted an online three-arm parallel randomized controlled trial (RCT) involving 792 adult participants (≥18 years, English-speaking) from the United States. The intervention group viewed a SAS video on COVID-19 vaccination, the attention placebo control group watched a SAS video on hope, and the control group received no intervention. Our primary objectives were to assess the influence of SAS videos on knowledge, behavioral intent, and engagement regarding COVID-19 vaccination. Participants in the intervention group displayed significantly higher mean knowledge scores (20.6, 95 % CI: 20.3-20.9) compared to both the attention placebo control (18.8, 95 % CI: 18.5-19.1, P  < .001) and control groups (18.7, 95 % CI: 18.4-19.0, P < .001). However, SAS videos did not notably affect behavioral intent. Perception of COVID-19 as a significant health threat emerged as a strong predictor for engaging with the post-trial video without further incentives (OR: 0.44; 95 % CI: 0.2-0.96). The 35-44 age group exhibited the highest post-trial engagement ( P  = .006), whereas right-wing political inclination negatively associated with engagement (OR: 1.98; 95 % CI: 3.9-1.01). Vaccination status correlated significantly with self-efficacy ( P  < .001), perceived social norms (P < .001), and perceived response efficacy of the COVID-19 vaccine (P < .001), all heightened in the intervention group. These findings suggest that while SAS videos effectively amplify COVID-19 vaccination knowledge, their impact on behavioral intent is not direct. They do, however, affect determinants of vaccination status, thereby indirectly influencing vaccination behavior. The study highlights the appeal of SAS videos among younger audiences, but underscores the need for further examination of factors impeding vaccination engagement. As SAS videos closely mirror conventional social media content, they hold significant potential as a public health communication tool on these platforms. Trial Registration: Trial was registered at drks.de with the identifier DRKS00027938, on 5 January 2022., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2023 The Authors.)

Background: Uncontrolled hypertension is a leading risk factor for cardiovascular diseases. In Uganda, such diseases account for approximately 10% of all deaths, with 1 in 5 adults having hypertension (>90% of the hypertensive cases are uncontrolled). Although basic health care in the country is available free of cost at government facilities, regularly accessing medication to control hypertension is difficult because supply chain challenges impede availability. Clients therefore frequently suspend treatment or buy medication individually at private facilities or pharmacies (incurring significant costs). In recent years, mobile health (mHealth) interventions have shown increasing potential in addressing health system challenges in sub-Saharan Africa, but the acceptability, feasibility, and uptake conditions of mobile money approaches to chronic disease management remain understudied., Objective: This study aims to design and pilot-test a mobile money-based intervention to increase the availability of antihypertensive medication and lower clients' out-of-pocket payments. We will build on existing local approaches and assess the acceptability, feasibility, and uptake of the designed intervention. Furthermore, rather than entering the study setting with a ready-made intervention, this research will place emphasis on gathering applied ethnographic insights early, which can then inform the parameters of the intervention prototype and concurrent trial., Methods: We will conduct a mixed methods study following a human-centered design approach. We will begin by conducting extensive qualitative research with a range of stakeholders (clients; health care providers; religious, cultural, and community leaders; academics; and policy makers at district and national levels) on their perceptions of hypertension management, money-saving systems, and mobile money in the context of health care. Our results will inform the design, iterative adaptation, and implementation of an mHealth-facilitated pooled financing intervention prototype. At study conclusion, the finalized prototype will be evaluated quantitatively via a randomized controlled trial., Results: As of August 2023, qualitative data collection, which started in November 2022, is ongoing, with data analysis of the first qualitative interviews underway to inform platform and implementation design. Recruitment for the quantitative part of this study began in August 2023., Conclusions: Our results aim to inform the ongoing discourse on novel and sustainable pathways to facilitate access to medication for the management of hypertension in resource-constrained settings., Trial Registration: German registry of clinical trials DRKS00030922; https://drks.de/search/en/trial/DRKS00030922., International Registered Report Identifier (irrid): DERR1-10.2196/46614., (©Josephine Schwab, Jonas Wachinger, Richard Munana, Maxencia Nabiryo, Isaac Sekitoleko, Juliette Cazier, Rebecca Ingenhoff, Caterina Favaretti, Vasanthi Subramonia Pillai, Ivan Weswa, John Wafula, Julius Valentin Emmrich, Till Bärnighausen, Felix Knauf, Samuel Knauss, Christine K Nalwadda, Nikkil Sudharsanan, Robert Kalyesubula, Shannon A McMahon. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 30.11.2023.)

Background and Aim: The Decree of the President of the Italian Republic 14/01/1997 is the reference norm related to the accreditation of public and private healthcare structures. This guideline establishes the minimum structural, technological and organizational requirements that each structure operating in the Italian territory must comply with., Methods: In occasion of the project work for the postgraduate training course in healthcare management by ALTEMS School, a team of researchers conducted a survey on the state of updating of the minimum structural requirements indicated in the norm-in particular those relating to hospital facilities- with those adopted by the individual regions through the analysis of the most up-to-date regional regulations., Results: Precisely starting from the comparison of regional references and from the regulations on the subject of structural accreditation which suggest strategic environmental units and which address some key-aspects relating to the contemporary design of healing environments (i.e. semi-intensive care units, hybrid operating theatres, etc.), the outcome of the project work is to define a proposal to update the national reference document, also in the light of the currently changing needs in terms of hospital design., Conclusions: The research aims to become a starting milestone for future investigations. The team investigated - in this first phase - the functional areas listed in the norm, and the next step aims to extend the analysis also to the innovative functions (i.e. buffer spaces, hybrid operating theatres, sub-intensive care units, etc.) and/or introduced only the last years which have only been regulated in some regions.

COVID-19 misinformation has spread rapidly across social media. To counter misinformation, we designed a short, wordless and animated video (called the CoVideo) to deliver scientifically informed and emotionally compelling information about preventive COVID-19 behaviours. After 15 163 online participants were recruited from Germany, Mexico, Spain, the UK and the USA, we offered participants in the attention placebo control (APC) and do-nothing arms the option to watch the CoVideo (without additional compensation) as post-trial access to treatment. The objective of our study was to evaluate participant engagement by quantifying (i) the proportion of participants opting to watch the CoVideo and (ii) the duration of time spent watching the CoVideo. We quantified the CoVideo opt-in and view time by experimental arm, age, gender, educational status, country of residence and COVID-19 prevention knowledge. Overall engagement with the CoVideo was high: 72% of the participants [CI: 71.1%; 73.0%] opted to watch the CoVideo with an average view time of 138.9 out of 144.0 s [CI: 138.4; 139.4], with no statistically significant differences by arm. Older participants (35-59 years) and participants with higher COVID-19 prevention knowledge had higher view times than their counterparts. Spanish participants had the highest opt-in percentage whereas Germans exhibited the shortest view times of the five countries. Short, wordless and animated storytelling videos, optimized for 'viral spread' on social media, can enhance global engagement with COVID-19 prevention messages by transcending cultural, language and literary barriers., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Italy was the first country in the western world to be affected by the COVID-19 pandemic, arguably among the worst-affected ones, counting 12 million cases and 150 thousand deaths two years since the first case. Facing new challenges, Italy has enacted different strategies and policies to limit the spread of the SARS-CoV-2 virus and treat those affected by COVID-19. This narrative review provided an overview of factors, measures, and actions that shaped Italy's first two years of the COVID-19 pandemic by investigating epidemiological data and using a mixed-method approach. This narrative review aimed to summarize the most relevant aspects and measures and analyze available data to provide policymakers and healthcare providers with the instruments to learn from this pandemic and improve their preparedness for future pandemic events. The first two years of the pandemic differ in that, during the first year, significant necessary changes to the way health systems were organized were implemented, increasing healthcare spending and adopting social and physical distancing measures that were stricter than the ones adopted in the second year. However, as the pandemic progressed, increased knowledge of the virus and related variants, as well as the introduction of highly effective vaccines, which were not equally available to the whole population, resulted in a stratification of COVID-19 infections and deaths based on factors such as age, vaccination status, and individual susceptibility to the virus.

To work efficiently in healthcare organizations and optimize resources, team members should agree with their leader's decisions critically. However, nowadays, little evidence is available in the literature. This systematic review and meta-analysis has assessed the effectiveness of leadership interventions in improving healthcare outcomes such as performance and guidelines adherence. Overall, the search strategies retrieved 3,155 records, and 21 of them were included in the meta-analysis. Two databases were used for manuscript research: PubMed and Scopus. On 16th December 2019 the researchers searched for articles published in the English language from 2015 to 2019. Considering the study designs, the pooled leadership effectiveness was 14.0% (95%CI 10.0-18.0%) in before-after studies, whereas the correlation coefficient between leadership interventions and healthcare outcomes was 0.22 (95%CI 0.15-0.28) in the cross-sectional studies. The multi-regression analysis in the cross-sectional studies showed a higher leadership effectiveness in South America (β = 0.56; 95%CI 0.13, 0.99), in private hospitals (β = 0.60; 95%CI 0.14, 1.06), and in medical specialty (β = 0.28; 95%CI 0.02, 0.54). These results encourage the improvement of leadership culture to increase performance and guideline adherence in healthcare settings. To reach this purpose, it would be useful to introduce a leadership curriculum following undergraduate medical courses., Competing Interests: The authors declare no conflict of interest.

Introduction: Exposure to a high volume of vaccine misinformation on social media can have a negative effect on vaccine confidence and rates. To counteract misinformation, we designed a collage of three short, animated story-based (SAS) videos to convey scientifically informed and accessible information about COVID-19 vaccine applicable to a social media context., Methods and Analysis: We will conduct an online randomized controlled trial primarily to: (1) determine the effectiveness of SAS videos in improving COVID-19 vaccine knowledge; (2) evaluate the effectiveness of SAS videos in increasing behavioral intent for COVID-19 vaccination; and (3) quantify people's interest in watching SAS videos about the COVID-19 vaccine. We also aim to identify barriers and facilitators to COIVD-19 vaccinations that have been shown to minimize vaccine hesitancy between vaccinated and unvaccinated populations. Using a web-based recruitment platform, a total of 10,000 adults from the United States will be recruited and randomly assigned to (1) a SAS video collage arm, (2) an attention placebo control video arm, or (3) no intervention arm (1:1:1). Furthermore, we will measure behavioral intent to obtain information on vaccination regarding COVID-19. At the end of the trial, participants randomized to arm 2 and arm 3 will be given the option of watching one of the intervention videos voluntarily to assess participant engagement with SAS videos. Finally, we will assess individual factors associated with vaccine hesitancy - hope, optimism, COVID-19 perceived risks and benefits, self-efficacy, perceived social norms, and trust - and compare vaccinated and unvaccinated participants across the three arms., Discussions: Evidence-based information from official channels can be complex and inaccessible to the general public, whereas false information on social media is frequently shared in brief postings, images, or videos that can easily reach the general public, thereby rapidly disseminating (mis-)information. To avoid the spread of misinformation, social media may be used to deliver evidence-based and emotionally compelling information in a readily accessible format in order to pre-empt misinformation. Our findings may help inform future SAS efforts addressing COVID-19 and other important public health challenges., Ethics and Dissemination: The study was approved by the Heidelberg University Hospital's Ethics Committee (S-163/2022). The trial was registered with German Clinical Trials Register (www.drks.de) on 5 January 2022: number DRKS00027938. Findings of the study will be published in peer-reviewed scientific publications and possibly presented at scientific conferences., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer RMS declared a shared affiliation with the author FB to the handling editor at the time of review., (Copyright © 2022 Barteit, Hachaturyan, Beleites, Kühn, Favaretti, Adam and Bärnighausen.)

Background: Fear over side-effects is one of the main drivers of COVID-19 vaccine hesitancy. A large literature in the behavioral and communication sciences finds that how risks are framed and presented to individuals affects their judgments of its severity. However, it remains unknown whether such framing changes can affect COVID-19 vaccine behavior and be deployed as policy solutions to reduce hesitancy., Methods: We conducted a pre-registered randomized controlled trial among 8998 participants in the United States and the United Kingdom to examine the effects of different ways of framing and presenting vaccine side-effects on individuals' willingness to get vaccinated and their perceptions of vaccine safety., Results: Adding a descriptive risk label ('very low risk') next to the numerical side-effect and providing a comparison to motor-vehicle mortality increased participants' willingness to take the COVID-19 vaccine by 3.0 percentage points (p=0.003) and 2.4 percentage points (p=0.049), respectively. These effects were independent and additive and combining both framing strategies increased willingness to receive the vaccine by 6.1 percentage points (p<0.001). Mechanistically, we find evidence that these framing effects operate by increasing individuals' perceptions of how safe the vaccine is., Conclusions: Low-cost side-effect framing strategies can meaningfully affect vaccine intentions at a population level., Funding: Heidelberg Institute of Global Health., Clinical Trial Number: German Clinical Trials Registry (#DRKS00025551)., Competing Interests: NS, CF, VH, AV No competing interests declared, TB TB received consultancy fees for KfW on the OSCAR initiative in Vietnam. TB also participated in the following: NIH-funded study "Healthy Options", Chair of the Data Safety and Monitoring Board (DSMB), German National Committee on the "Future of Public Health Research and Education", Chair of the scientific advisory board to the EDCTP Evaluation, Member of the UNAIDS Evaluation Expert Advisory Committee, National Institutes of Health Study Section Member on Population and Public Health Approaches to HIV/AIDS (PPAH), US National Academies of Sciences, Engineering, and Medicine's Committee for the "Evaluation of Human Resources for Health in the Republic of Rwanda under the President's Emergency Plan for AIDS Relief (PEPFAR)", University of Pennsylvania (UPenn) Population Aging Research Center (PARC) External Advisory Board Member, Co-chair of the Global Health Hub Germany (which was initiated by the German Ministry of Health). The author has no other competing interests to declare, (© 2022, Sudharsanan et al.)

Background: Short, animated story-based (SAS) videos are a novel and promising strategy for promoting health behaviors. To gain traction as an effective health communication tool, SAS videos must demonstrate their potential to engage a diverse and global audience. In this study, we evaluate engagement with a SAS video about the consumption of added sugars, which is narrated by a child (a nonthreatening character), a mother (a neutral layperson), or a physician (a medical expert)., Objective: This study aims to (1) assess whether engagement with the sugar intervention video differs by narrator type (child, mother, physician) and trait proneness to reactance and (2) assess whether the demographic characteristics of the participants (age, gender, education status) are associated with different engagement profiles with the sugar intervention video., Methods: In December 2020, after 4013 participants from the United Kingdom completed our randomized controlled trial, we offered participants assigned to the placebo arms (n=1591, 39.65%) the choice to watch the sugar intervention video (without additional compensation) as posttrial access to treatment. We measured engagement as the time that participants chose to watch the 3.42-minute video and collected data on age, gender, education status, and trait reactance proneness. Using ordinary least squares regression, we quantified the association of the demographic characteristics and trait reactance proneness with the sugar video view time., Results: Overall, 66.43% (n=1047) of the 1576 participants in the 2 placebo arms voluntarily watched the sugar intervention video. The mean view time was 116.35 (52.4%) of 222 seconds. Results show that view times did not differ by narrator (child, mother, physician) and that older participants (aged 25-59 years, mean = 125.2 seconds) watched the sugar video longer than younger adults (aged 18-25 years, mean = 83.4 seconds). View time remained consistent across education levels. Participants with low trait reactance (mean = 119.3 seconds) watched the intervention video longer than high-trait-reactance participants (mean = 95.3 seconds), although this association did not differ by narrator type., Conclusions: The majority of participants in our study voluntarily watched more than half of the sugar intervention video, which is a promising finding. Our results suggest that SAS videos may need to be shorter than 2 minutes to engage people who are young or have high trait proneness to reactance. We also found that the choice of narrator (child, mother, or physician) for our video did not significantly affect participant engagement. Future videos, aimed at reaching diverse audiences, could be customized for different age groups, where appropriate., Trial Registration: German Clinical Trials Register DRKS00022340; https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00022340., International Registered Report Identifier (irrid): RR2-10.2196/25343., (©Caterina Favaretti, Alain Vandormael, Violetta Hachaturyan, Merlin Greuel, Jennifer Gates, Till Bärnighausen, Maya Adam. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 24.01.2022.)

Background: Short and animated story-based (SAS) videos can be an effective strategy for promoting health messages. However, health promotion strategies often motivate the rejection of health messages, a phenomenon known as reactance. In this study, we examine whether the child narrator of a SAS video (perceived as nonthreatening, with low social authority) minimizes reactance to a health message about the consumption of added sugars., Objective: This study aims to determine whether our SAS intervention video attenuates reactance to the sugar message when compared with a content placebo video (a health message about sunscreen) and a placebo video (a nonhealth message about earthquakes) and determine if the child narrator is more effective at reducing reactance to the sugar message when compared with the mother narrator (equivalent social authority to target audience) or family physician narrator (high social authority) of the same SAS video., Methods: This is a web-based randomized controlled trial comparing an intervention video about sugar reduction narrated by a child, the child's mother, or the family physician with a content placebo video about sunscreen use and a placebo video about earthquakes. The primary end points are differences in the antecedents to reactance (proneness to reactance, threat level of the message), its components (anger and negative cognition), and outcomes (source appraisal and attitude). We performed analysis of variance on data collected (N=4013) from participants aged 18 to 59 years who speak English and reside in the United Kingdom., Results: Between December 9 and December 11, 2020, we recruited 38.62% (1550/4013) men, 60.85% (2442/4013) women, and 0.52% (21/4013) others for our study. We found a strong causal relationship between the persuasiveness of the content promoted by the videos and the components of reactance. Compared with the placebo (mean 1.56, SD 0.63) and content placebo (mean 1.76, SD 0.69) videos, the intervention videos (mean 1.99, SD 0.83) aroused higher levels of reactance to the message content (P<.001). We found no evidence that the child narrator (mean 1.99, SD 0.87) attenuated reactance to the sugar reduction message when compared with the physician (mean 1.95, SD 0.79; P=.77) and mother (mean 2.03, SD 0.83; P=.93). In addition, the physician was perceived as more qualified, reliable, and having more expertise than the child (P<.001) and mother (P<.001) narrators., Conclusions: Although children may be perceived as nonthreatening messengers, we found no evidence that a child narrator attenuated reactance to a SAS video about sugar consumption when compared with a physician. Furthermore, our intervention videos, with well-intended goals toward audience health awareness, aroused higher levels of reactance when compared with the placebo videos. Our results highlight the challenges in developing effective interventions to promote persuasive health messages., Trial Registration: German Clinical Trials Registry DRKS00022340; https://tinyurl.com/mr8dfena., International Registered Report Identifier (irrid): RR2-10.2196/25343., (©Violetta Hachaturyan, Maya Adam, Caterina Favaretti, Merlin Greuel, Jennifer Gates, Till Bärnighausen, Alain Vandormael. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 22.11.2021.)

Background: Short and animated story-based (SAS) videos, which can be rapidly distributed through social media channels, are a novel and promising strategy for promoting health behaviors. In this study, we evaluate the effectiveness of a SAS video intervention to reduce the consumption of added sugars., Methods: In December 2020, we randomized 4159 English-speaking participants from the United Kingdom (1:1:1) to a sugar intervention video, a content placebo video about sunscreen use (no sugar message), or a placebo video about earthquakes (no health or sugar message). We nested six list experiments in each arm and randomized participants (1:1) to a control list or a control list plus an item about consuming added sugars. The primary end-points were mean differences (on a scale of 0-100) in behavioral intent and direct restoration of freedom to consume added sugars., Results: Participants (N = 4013) who watched the sugar video had significantly higher behavioral intent to cut their daily intake of added sugar (mean difference (md) = 16.7, 95% confidence interval (CI) = 1.5-31.8, P  = 0.031), eat fresh fruit daily (md = 16.7, 95% CI = 0.5-32.9, P  = 0.043), and check food labels for sugar content (md = 20.5, 95% CI = 2.6-38.5, P  = 0.025) when compared with the sunscreen (content placebo) video. The sugar video did not arouse intent to restore freedom and consume added sugars when compared with the two placebo videos., Conclusions: Our SAS intervention video did not arouse reactance and increased short-term behavioral intent among participants to reduce their consumption of added sugars. SAS videos, which draw on best practices from the entertainment-education media, communication theory, and the animation industry, can be an effective strategy for delivering emotionally compelling narratives to promote health behavior change., Trial Registration: German Clinical Trials Register: DRKS00022340., Competing Interests: Competing interests: The authors have completed the ICMJE Declaration of Interest Form (available upon request from the corresponding author) and declare no conflicts of interest.Correspondence to:
Dr Alain Vandormael
Heidelberg Institute of Global Health (HIGH)
Im Neuenheimer Feld 130/3
Heidelberg University
Heidelberg 69120
Germany
alain.vandormael@uni-heidelberg.de, (Copyright © 2021 by the Journal of Global Health. All rights reserved.)

Background: Innovative approaches to the dissemination of evidence-based COVID-19 health messages are urgently needed to counter social media misinformation about the pandemic. To this end, we designed a short, wordless, animated global health communication video (the CoVideo), which was rapidly distributed through social media channels to an international audience., Objective: The objectives of this study were to (1) establish the CoVideo's effectiveness in improving COVID-19 prevention knowledge, and (2) establish the CoVideo's effectiveness in increasing behavioral intent toward COVID-19 prevention., Methods: In May and June 2020, we enrolled 15,163 online participants from the United States, Mexico, the United Kingdom, Germany, and Spain. We randomized participants to (1) the CoVideo arm, (2) an attention placebo control (APC) arm, and (3) a do-nothing arm, and presented 18 knowledge questions about preventive COVID-19 behaviors, which was our first primary endpoint. To measure behavioral intent, our second primary endpoint, we randomized participants in each arm to five list experiments., Results: Globally, the video intervention was viewed 1.2 million times within the first 10 days of its release and more than 15 million times within the first 4 months. Knowledge in the CoVideo arm was significantly higher (mean 16.95, 95% CI 16.91-16.99) than in the do-nothing (mean 16.86, 95% CI 16.83-16.90; P<.001) arm. We observed high baseline levels of behavioral intent to perform many of the preventive behaviors featured in the video intervention. We were only able to detect a statistically significant impact of the CoVideo on one of the five preventive behaviors., Conclusions: Despite high baseline levels, the intervention was effective at boosting knowledge of COVID-19 prevention. We were only able to capture a measurable change in behavioral intent toward one of the five COVID-19 preventive behaviors examined in this study. The global reach of this health communication intervention and the high voluntary engagement of trial participants highlight several innovative features that could inform the design and dissemination of public health messages. Short, wordless, animated videos, distributed by health authorities via social media, may be an effective pathway for rapid global health communication during health crises., Trial Registration: German Clinical Trials Register DRKS00021582; https://tinyurl.com/6r4zkbbn., International Registered Report Identifier (irrid): RR2-10.1186/s13063-020-04942-7., (©Alain Vandormael, Maya Adam, Merlin Greuel, Jennifer Gates, Caterina Favaretti, Violetta Hachaturyan, Till Bärnighausen. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 27.07.2021.)

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our "Perspective" illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

Background: Countries in Africa progressively implement performance-based financing schemes to improve the quality of care provided by maternal, newborn and child health services. Beyond its direct effects on service provision, evidence suggests that performance-based financing can also generate positive externalities on service utilization, such as increased use of those services that reached higher quality standards after effective scheme implementation. Little, however, is known about externalities generated within non-incentivized health services, such as positive or negative effects on the quality of services within the continuum of maternal care., Methods: We explored whether a performance-based financing scheme in Malawi designed to improve the quality of childbirth service provision resulted positive or negative externalities on the quality of non-targeted antenatal care provision. This non-randomized controlled pre-post-test study followed the phased enrolment of facilities into a performance-based financing scheme across four districts over a two-year period. Effects of the scheme were assessed by various composite scores measuring facilities' readiness to provide quality antenatal care, as well as the quality of screening, prevention, and education processes offered during observed antenatal care consultations., Results: Our study did not identify any statistically significant effects on the quality of ANC provision attributable to the implemented performance-based financing scheme. Our findings therefore suggest not only the absence of positive externalities, but also the absence of any negative externalities generated within antenatal care service provision as a result of the scheme implementation in Malawi., Conclusions: Prior research has shown that the Malawian performance-based financing scheme was sufficiently effective to improve the quality of incentivized childbirth service provision. Our findings further indicate that scheme implementation did not affect the quality of non-incentivized but clinically related antenatal care services. While no positive externalities could be identified, we also did not observe any negative externalities attributable to the scheme's implementation. While performance-based incentives might be successful in improving targeted health care processes, they have limited potential in producing externalities - neither positive nor negative - on the provision quality of related non-incentivized services.

Background: Entertainment-education media can be an effective strategy for influencing health behaviors. To improve entertainment-education effectiveness, we seek to investigate whether the social authority of a person delivering a health message arouses the motivation to reject that message-a phenomenon known as reactance., Objective: In this study, using a short animated video, we aim to measure reactance to a sugar reduction message narrated by a child (low social authority), the child's mother (equivalent social authority to the target audience), and a family physician (high social authority). The aims of the study are to determine the effect of the narrator's perceived social authority on reactance to the sugar reduction message, establish the effectiveness of the video in improving behavioral intent to reduce the intake of added sugars, and quantify participants' interest in watching the entertainment-education intervention video., Methods: This is a parallel group, randomized controlled trial comparing an intervention video narrated by a low, equivalent, or high social authority against a content placebo video and a placebo video. Using a web-based recruitment platform, we plan to enroll 4000 participants aged between 18 and 59 years who speak English and reside in the United Kingdom. The primary end points will include measures of the antecedents to reactance (proneness to reactance and threat level of the message), its components (anger and negative cognition), and attitudinal and behavioral intent toward sugar intake. We will measure behavioral intent using list experiments. Participants randomized to the placebo videos will be given a choice to watch one of the sugar-intervention videos at the end of the study to assess participant engagement with the entertainment-education video., Results: The study was approved by the ethics committee of Heidelberg University on March 18, 2020 (S-088/2020). Participant recruitment and data collection were completed in December 2020. The data analysis was completed in April 2021, and the final results are planned to be published by August 2021., Conclusions: In this trial, we will use several randomization procedures, list experimentation methods, and new web-based technologies to investigate the effect of perceived social authority on reactance to a message about reducing sugar intake. Our results will inform the design of future entertainment-education videos for public health promotion needs., Trial Registration: German Clinical Trials Registry DRKS00022340: https://www.drks.de/drks&#95;web/navigate.do?navigationId=trial.HTML&TRIAL&#95;ID=DRKS00022340., International Registered Report Identifier (irrid): DERR1-10.2196/25343., (©Alain Vandormael, Maya Adam, Violetta Hachaturyan, Merlin Greuel, Caterina Favaretti, Jennifer Gates, Till Baernighausen. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.05.2021.)

The European Network for Health Technology Assessment (EUnetHTA) organizes an annual Forum with stakeholders to receive feedback on its activities, processes, and outputs produced. The fourth edition of the EUnetHTA Forum brought together representatives of HTA bodies, patient organizations, healthcare professionals (HCPs), academia, payers, regulators, and industry. The aim of this paper is to provide an overview of the highlights presented at the 2019 EUnetHTA Forum, reporting the main items and themes discussed in the plenary panel and breakout sessions. The leading topic was the concept of unmet medical need seen from different stakeholders' perspectives. Breakout sessions covered the joint production of assessment reports and engagement with payers, patients, and HCPs. Synergies, pragmatism, and inclusiveness across Member States and stakeholders were emphasized as leading factors to put in place a collaboration that serves the interest of patients and public health in a truly European spirit.

Objectives: Evaluation is crucial for integration of e-Health/m-Health into healthcare systems and health technology assessment (HTA) could offer sound methodological basis for these evaluations. Aim of this study was to look for HTA reports on e-Health/m-Health technologies and to analyze their transparency, consistency and thoroughness, with the goal to detect areas that need improvement., Methods: PubMed, ISI-WOS, and University of York - Centre for Reviews and Dissemination-electronic databases were searched to identify reports on e-Health/m-Health technologies, published up until April 1, 2016. The International Network of Agencies for Health Technology Assessment (INAHTA) checklist was used to evaluate transparency and consistency of included reports. Thoroughness was assessed by checking the presence of domains suggested by the European network for Health Technology Assessment (EUnetHTA) HTA Core Model., Results: Twenty-eight reports published between 1999 and 2015 were included. Most were delivered by non-European countries (71.4 percent) and only 35.7 percent were classified as full reports. All the HTA reports defined the scope of research whereas more than 80 percent provided author details, summary, discussed findings, and conclusion. On the contrary, policy and research questions were clearly defined in around 30 percent and 50 percent of reports. With respect to the EUnetHTA Core Model, around 70 percent of reports dealt with effectiveness and economic evaluation, more than 50 percent described health problem and approximately 40 percent organizational and social aspects., Conclusions: E-Health/m-Health technologies are increasingly present in the field of HTA. Yet, our review identified several missing elements. Most of the reports failed to respond to relevant assessment components, especially ethical, social and organizational implications.

Background: Non-communicable diseases (NCDs) kill 40 million people each year. The management of chronic respiratory NCDs such as chronic obstructive pulmonary disease (COPD) is particularly critical in Italy, where they are widespread and represent a heavy burden on healthcare resources. It is thus important to redefine the role and responsibility of respiratory specialists and their scientific societies, together with that of the whole healthcare system, in order to create a sustainable management of COPD, which could become a model for other chronic respiratory conditions., Methods: These issues were divided into four main topics (Training, Organization, Responsibilities, and Sustainability) and discussed at a Consensus Conference promoted by the Research Center of the Italian Respiratory Society held in Rome, Italy, 3-4 November 2016., Results and Conclusions: Regarding training, important inadequacies emerged regarding specialist training - both the duration of practical training courses and teaching about chronic diseases like COPD. A better integration between university and teaching hospitals would improve the quality of specialization. A better organizational integration between hospital and specialists/general practitioners (GPs) in the local community is essential to improve the diagnostic and therapeutic pathways for chronic respiratory patients. Improving the care pathways is the joint responsibility of respiratory specialists, GPs, patients and their caregivers, and the healthcare system. The sustainability of the entire system depends on a better organization of the diagnostic-therapeutic pathways, in which also other stakeholders such as pharmacists and pharmaceutical companies can play an important role.

Background: For better supporting the science-governance interface, the potential of health assessments appears underrated., Aims: To identify what various types of health assessment have in common; how they differ; which assessment(s) to apply for which purpose; and what needs and options there are for future joint development., Methods: This review is based on five types of health assessment: monitoring/surveillance/reporting, assessment of health impact, of health technology, of health systems performance, health-related economic assessment. The approach is exploratory and includes: applying an agreed set of comparative criteria; circulating and supplementing synoptic tables; and interpreting the results., Results: Two of the assessments deal with the question 'Where do we stand?', two others with variants of 'What if' questions. Economic Assessment can take place in combination with any of the others. The assessments involve both overall 'procedures' and a variety of 'methods' which inescapably reflect some subjective assumptions and decisions, e.g. on issue framing. Resources and assistance exist for all these assessments. The paper indicates which type of assessment is appropriate for what purpose., Conclusions: Although scientific soundness of health assessments is not trivial to secure, existing types of health assessment can be interpreted as a useful 'toolkit' for supporting governance. If current traces of 'silo' thinking can be overcome, the attainability of a more unified culture of health assessments increases and such assessments might more widely be recognized as a prime, 'tried and tested' way to voice Public Health knowledge and to support rational governance and policy-making., (© The Author 2017. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.)

Breakthrough cancer Pain (BTcP) has a high prevalence in cancer population. Patients with BTcP reported relevant health care costs and poor quality of life. The study assessed the cost-effectiveness of the available Oral Fentanyl Formulations (OFFs) for BTcP in Italy. A decision-analytical model was developed to estimate costs and benefits associated with treatments, from the Italian NHS perspective. Expected reductions in pain intensity per BTcP episodes were translated into, percentage of BTcP reduction, resource use and Quality-Adjusted-Life-Years (QALYs). Relative efficacy, resources used and unit costs data were derived from the literature and validated by clinical experts. Probabilistic and deterministic sensitivity analyses were performed. At base-case analysis, Sublingual Fentanyl Citrate (FCSL) compared to other oral formulations reported a lower patient's cost (€1,960.8) and a higher efficacy (18.7% of BTcP avoided and 0.0507 QALYs gained). The sensitivity analyses confirmed the main results in all tested scenarios, with the highest impact reported by BTcP duration and health care resources consumption parameters. Between OFFs, FCSL is the cost-effective option due to faster reduction of pain intensity. However, new research is needed to better understand the economic and epidemiologic impact of BTcP, and to collect more robust data on economic and quality of life impact of the different fentanyl formulations. Different fentanyl formulations are available to manage BTcP in cancer population. The study is the first that assesses the different impact in terms of cost and effectiveness of OFFs, providing new information to better allocate the resources available to treat BTcP and highlighting the need of better data.

Introduction: Health Technology Assessment (HTA) plays a key role in the policy and decision-making process. Nevertheless, it is time- and resource-consuming, and therefore requires proper resource allocation. Priority setting, as a best way to organize effective and explicit resource allocation systems, may be applied even in this field., Objective: The aim of this study was to provide an overview of criteria used for priority setting in HTA at European level., Methods: A systematic review of the scientific literature was performed through PubMed alongside consultation of the websites of the European HTA Agencies belonging to the INAHTA. The search was limited to papers written in English and provided with the full text. Documents were considered eligible if providing criteria for priority setting in HTA., Results: Seven scientific articles were retrieved from PubMed and 14 European HTA Agencies released prioritization criteria were analysed. The most relevant criteria were: frequency/burden of disease, economic impact and costs, potential benefits, impact on ethical, social, cultural and/or legal aspects., Conclusion: This work is meant to contribute to supranational discussion on priority setting at European level and shows that, despite the available evidence, work still needs to be done toward harmonization and sharing of the criteria to adopt.

Purpose: The purpose of this paper is to account for a ten-year experience with the European Foundation for Quality Management (EFQM) Excellence Model implemented in the Trento Healthcare Trust., Design/methodology/approach: Since 2000, the EFQM Excellence Model provided an overarching framework to streamline business process governance, to support and improve its enablers and results. From 2000 to 2009, staff performed four internal (self) and four external EFQM-based assessments that provided guidance for an integrated management system. Over the years, key controls and assurances improved service quality through business planning, learning and practice cycles., Findings: Rising assessment ratings and improving results characterized the journey. The average self-assessment score (on a 1,000 points scale) was 290 in 2001, which increased to 610 in 2008. Since 2006, the Trust has been Recognized for Excellence (four stars). The organization improved significantly on customer satisfaction, people results and key service delivery and outcomes., Practical Implications: The EFQM Model can act as an effective tool to meet governance demands and promote system-level results. The approach to integrated governance discussed here may support similar change processes in comparable organizations., Originality/value: The paper describes a unique experience when implementing EFQM within a large Italian healthcare system, which had a broader reach and lasted longer than any experience in Italian healthcare.

This study was aimed at increasing the clinical usefulness of clinical pharmacological advice (CPA) for personalized drug dosing based on therapeutic drug monitoring (TDM). Educational and organizational interventions focused on improving the knowledge of clinical pharmacology among hospital healthcare workers and reducing the incidence of errors throughout the process were planned. After a pre-interventional period of risk assessment, different list forms of the types of error occurring in the various phases of the process (Phase 1, request for CPA and blood sampling for TDM; Phase 2, sample delivery to and check in at the CPU; Phase 3, TDM execution and CPA production) were created. In the interventional period, the errors were collected daily and educational programmes were carried out. The pre-intervention error rate was 19.5%, and resulted significantly higher for the requests coming from the medical wards compared with those from the surgical wards or the ICUs (26.0% versus 10.5% versus 13.7%, p < 0.001). The educational programme trained 303 nurses and 145 physicians. Afterwards, the error percentage progressively dropped (15.5% in the 2nd trimester; 12.3% in the 3rd one; 10.5% in the 4th one). The adopted strategy resulted in significant improvements which may be useful both to improve quality of patient care and to reduce waste in healthcare costs., (© 2014 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).)

Objectives: The aim of this study was to review the history of health technology assessment (HTA) in Italy., Methods: Founded in 1978, the Italian National Health Service (NHS) has been strongly regionalized mainly after a constitutional reform, which started a devolution process. HTA started in the 1980s at the National Institute of Health and in a few University Hospitals, with a focus on big ticket technology: that process was driven by clinical engineers., Results: In recent years, HTA is becoming an important tool for decision-making processes at central, regional, and local levels. In particular, the National Agency for Regional Health Services (AGENAS) and five regions (of twenty-one) are strongly committed to develop HTA initiatives connected with the planning process., Conclusions: At the local level, the hospital-based HTA activity is probably the most important peculiarity of the country and the real driver of the HTA movement.

The study aims to define the technical, ethical, juridical and economic issues involved in the assessment of a reprocessing policy for single-use interventional cardiac devices (SUDs). The feasibility of reprocessing was evaluated for cardiac electrophysiology catheters by comparing the chemical, physical and functional properties of new and reprocessed devices. The issue of hygiene was addressed by developing microbiological tests for the quantification of bioburden, sterility and pyrogenic load. The results of more than 1500 tests, conducted on 531 catheters, suggested a precautionary number of regenerations of five cycles. The ethical aspects were reviewed and the European juridical framework was assessed, revealing a need for harmonization. Applying a specific economic model, potential savings were calculated for a representative cardiology department and estimated at national and European level. Potential savings of 41.2% and 32.9% were calculated for diagnostic and ablation catheters, respectively. Safe and effective reprocessing of SUDs could be pursued if quality control processes and certified procedures are met. A reprocessing policy in EP laboratory could lead to savings of about 27,250 euros per 100,000 population, but the economic benefits are strongly dependent on the maximum number of regenerations and the regeneration rate.

Objectives: To examine the distribution of interventional cardiac catheterization laboratories, their case load, the time trends, and the regional variation of percutaneous transluminal cutaneous angioplasty (PTCA) utilization in Italy., Methods: Analysis of data was provided by the annual reports of the Italian Group of Studies and Interventional Cardiology over the period from 1983 to 1996., Results: The number of PTCA facilities and their use steadily increased, mainly in the North. In 1996 the utilization rate was 34 per 100,000 population, but only 60% of labs performed 200 or more procedures., Conclusions: Dramatic time trends and regional variations often took place without an epidemiology and technology assessment-based planning process.

The use of cardiac catheterization procedures and the number of hemodynamic laboratories in Italy increased steadily from 1983 through 1993, sometimes with no planning or modern technology assessment. It is recommended that in the future funds be assigned to improve underused laboratories rather than to build new facilities.

The authors present the findings of a study in three stages (1989-1991) on the appropriateness of human albumin use at the hospital of Padova, Italy. In the first stage, guidelines for appropriate use were defined and a monitoring system was set up. In the second stage, compliance of the hospital departments with the new guidelines was assessed in a sample of human albumin prescription charts and related medical records. This revealed a reduction in consumption of 25%. Sixty-eight per cent of all albumin was given for indications that are only occasionally appropriate. The information given in the prescription chart agreed with the diagnosis contained in the medical records in 78% of cases. At the end of this stage new regulating mechanisms were introduced. The third stage consisted of a medium-term assessment and produced basically the same results as the previous stage. Crucial steps in the implementation of effective actions in quality improvement processes have been discussed.

A quality improvement system has been established in 1989 in the hospital network of Padua and its organization is described. Three selected experiences are reported. (1) Appropriateness of the use of human albumin. After the assessment of the clinical policy, new guidelines were experimentally introduced and an evaluation after 3 months has shown a decrease of the total number of prescriptions (25%) and of inappropriate indications (9% vs 40.1%). (2) Urinary Tract Infections (UTI) and indwelling catheterization. The study showed 49% of conditions related to UTI and some corrigible inadequacies in the process of care: 37.2% of indications were probably not justified; 40% of patients who did not undergo urineculture had indications and 13% who underwent urineculture had no indications to the test. Guidelines for appropriate indications and a continuing education programme have been introduced. (3) Falls by hospitalized patients. The patient fall rate was 0.3/1000. As the reporting system showed inaccuracies (for example, the severity of injury was not collected in 34% of cases), a new notification form was introduced in 1991.