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Introduction Patient-centricity calls for accurate consideration of patients’ preferences at every step of the care pathway. Decision aids (DAs) are interventions that provide patients with information about treatment options, enabling shared decision-making (SDM). This study investigated the practice of SDM by breast cancer (BC) specialists and the diffusion of DAs in the treatment of BC in Europe. The secondary objective of the study was to explore heterogeneity across respondents’ subgroups. Methods A prospective, cross-sectional, cross-country questionnaire targeting breast specialists was distributed online across breast cancer networks at both national and European level. The survey results were analyzed descriptively. Mann-Whitney-U tests, and probit regressions were performed to explore differences between subgroups. Results Respondents were mostly medical oncologists and surgeons. Respondents expressed high comfort with SDM approach (mean: 4.29, CI95%: 4.15-4.44). The majority reported DAs were available, and used, in their organization. Statistically significant gender differences were observed, indicating that female physicians might be more prone to adopting SDM approaches with patients. Conclusions Patient-centricity calls for consideration of patients’ values. The specialists in this survey showed a promising attitude towards SDM. DAs availability translates into use, although this mainly refers to paper tools, whereas digital tools seem mostly illustrated in the literature.

COVID-19 pandemic challenges have accelerated the reliance on digital health fuelling the expanded incorporation of mobile apps into healthcare services, particularly for the management of long-term conditions such as chronic diseases (CDs). However, the impact of health apps on outcomes for CD remains unclear, potentially owing to both the poor adoption of formal development standards in the design process and the methodological quality of studies. A systematic search of randomised trials was performed on Medline, ScienceDirect, the Cochrane Library and Scopus to provide a comprehensive outlook and review the impact of health apps on CD. We identified 69 studies on diabetes ( n  = 29), cardiovascular diseases ( n  = 13), chronic respiratory diseases ( n  = 13), cancer ( n  = 10) or their combinations ( n  = 4). The apps rarely adopted developmental factors in the design stage, with only around one-third of studies reporting user or healthcare professional engagement. Apps differed significantly in content, with a median of eight behaviour change techniques adopted, most frequently pertaining to the ‘Feedback and monitoring’ (91%) and ‘Shaping knowledge’ (72%) categories. As for the study methodologies, all studies adopted a traditional randomised control trial (RCT) design, with relatively short follow-ups and limited sample sizes. Findings were not significant for the majority of studies across all CD, with most RCTs revealing a high risk of bias. To support the adoption of apps for CD management, this review reinforces the need for more robust development and appropriate study characteristics to sustain evidence generation and elucidate whether study results reflect the true benefits of apps or a biased estimate due to unsuitable designs.

Patient-reported outcomes (PROs) are any report of the status of a patient's health condition that comes directly from the patient (or in some cases from a caregiver or surrogate responder), without interpretation by a practitioner or anyone else. PROs are increasingly used as a valuable source of data in different domains of health care, including research, clinical practice, health care management, and decision making on the regulation, coverage, and reimbursement of new technologies. Several factors must be considered when selecting which PRO measure to use to ensure their appropriate use and interpretation as well as their relevance for decision makers. The increasing availability of PRO data, its integration with other data sources, and the improvements in data analytics offer a valuable opportunity to place the patient at the center of any health care process. However, several issues need to be addressed, including interoperability, data governance, security, privacy, and ethics, to realize an effective, integrated, standardized, real-time assessment of PROs in the health care systems.

Background Shared decision-making (SDM) is a collaborative process whereby patients and clinicians jointly deliberate on the best treatment option that takes into account patients’ preferences and values. In breast cancer care, different treatment options have become available to patients in the last decade. Various interventions, including patient decision aids (PtDAs), have been designed to promote SDM in this disease area. This study aimed at investigating the factors that influence the successful adoption and implementation of SDM interventions in real-world healthcare delivery settings. Methods A scoping review of scientific and grey literature was conducted for the period 2006–2021 to analyse the support for SDM interventions and their adoption in breast cancer clinical practice. The interpretation of findings was based on the Practical, Robust Implementation and Sustainability Model (PRISM) for integrating research findings into practice. Results Overall, 19 studies were included for data synthesis, with more than 70% published since 2017. The availability of SDM tools does not automatically translate into their actual use in clinical settings. Factors related to users’ co-creation, the clinical team’s attitude and knowledge, organisational support and regulatory provisions facilitate the adoption of SDM interventions. However, overlooking aspects such as the re-organisation of care pathways, patient characteristics, and assigning of resources (human, financial, and facilities) can hinder implementation efforts. Conclusions Compared to the mounting evidence on the efficacy of SDM interventions, knowledge to support their sustained implementation in daily care is still limited, albeit results show an increasing interest in strategies that facilitate their uptake in breast cancer care over time. These findings highlight different strategies that can be used to embed SDM interventions in clinical practice. Future work should investigate which approaches are more effective in light of organisational conditions and external factors, including an evaluation of costs and healthcare system settings.

Mobile health (mHealth) solutions have proven to be effective in a wide range of patient outcomes and have proliferated over time. However, a persistent challenge of digital health technologies, including mHealth, is that they are characterized by early dropouts in clinical practice and struggle to be used outside experimental settings or on larger scales. This study aimed to explore barriers and enablers to the uptake of mHealth solutions used by patients with cancer undergoing treatment, using a theory-guided implementation science model, that is, the Consolidated Framework for Implementation Research (CFIR). A scoping literature review was conducted using PubMed (MEDLINE), Web of Science, and ScienceDirect databases in March 2022. We selected studies that analyzed the development, evaluation, and implementation of mHealth solutions for patients with cancer that were used in addition to the standard of care. Only empirical designs (eg, randomized controlled trials, observational studies, and qualitative studies) were considered. First, information on the study characteristics, patient population, app functionalities, and study outcomes was extracted. Then, the CFIR model was used as a practical tool to guide data collection and interpretation of evidence on mHealth uptake. Overall, 91 papers were included in the data synthesis. The selected records were mostly randomized controlled trials (26/91, 29%) and single-arm, noncomparative studies (52/91, 57%). Most of the apps (42/73, 58%) were designed for both patients and clinicians and could be used to support any type of cancer (29/73, 40%) and a range of oncological treatments. Following the CFIR scheme (intervention, outer setting, inner setting, individuals, process), multistakeholder co-design, codevelopment, and testing of mHealth interventions were identified as key enablers for later uptake. A variety of external drivers emerged, although the most relevant outer incentive fostering mHealth use was addressing patient needs. Among organizational factors likely to influence technology uptake, interoperability was the most prominent, whereas other providers' dimensions such as managerial attitudes or organizational culture were not systematically discussed. Technology-related impediments that could hamper the use of mHealth at the individual level were considered least often. The hype surrounding mHealth in cancer care is hindered by several factors that can affect its use in real world and nonexperimental settings. Compared with the growing evidence on mHealth efficacy, knowledge to inform the uptake of mHealth solutions in clinical cancer care is still scarce. Although some of our findings are supported by previous implementation research, our analysis elaborates on the distinguishing features of mHealth apps and provides an integrated perspective on the factors that should be accounted for implementation efforts. Future syntheses should liaise these dimensions with strategies observed in successful implementation initiatives.

Background The aims of this research were to provide a better understanding of the specific evidence needs for assessment of clinical and cost-effectiveness of cell and gene therapies, and to explore the extent that the relevant categories of evidence are considered in health technology assessment (HTA) processes. Methods A targeted literature review was conducted to identify the specific categories of evidence relevant to the assessment of these therapies. Forty-six HTA reports for 9 products in 10 cell and gene therapy indications across 8 jurisdictions were analysed to determine the extent to which various items of evidence were considered. Results The items to which the HTA bodies reacted positively were: treatment was for a rare disease or serious condition, lack of alternative therapies, evidence indicating substantial health gains, and when alternative payment models could be agreed. The items to which they reacted negatively were: use of unvalidated surrogate endpoints, single arm trials without an adequately matched alternative therapy, inadequate reporting of adverse consequences and risks, short length of follow-up in clinical trials, extrapolating to long-term outcomes, and uncertainty around the economic estimates. Conclusions The consideration by HTA bodies of evidence relating to the particular features of cell and gene therapies is variable. Several suggestions are made for addressing the assessment challenges posed by these therapies. Jurisdictions conducting HTAs of these therapies can consider whether these suggestions could be incorporated within their existing approach through strengthening deliberative decision-making or performing additional analyses.

Italy was the first country in Europe to be hit by the Severe Acute Respiratory Syndrome Coronavirus 2. Little research has been conducted to understand the economic impact of providing care for SARS-CoV-2 patients during the pandemic. Our study aims to quantify the incremental healthcare costs for hospitalizations associated to being discharged before or after the first SARS-CoV-2 case was notified in Italy, and to a positive or negative SARS-CoV-2 notified infection. We used data on hospitalizations for 9 different diagnosis related groups at a large Italian Research Hospital with discharge date between 1st January, 2018 and 31st December 2021. The median overall costs for a hospitalization increased from 2410EUR (IQR: 1588–3828) before the start of the pandemic, to 2645EUR (IQR: 1885–4028) and 3834EUR (IQR: 2463–6413) during the pandemic, respectively for patients SARS-CoV-2 negative and positive patients. Interestingly, according to results of a generalized linear model, the highest increases in the average costs sustained for SARS-CoV-2 positive patients with respect to patients discharged before the pandemic was found among those with diagnoses unrelated to COVID-19, i.e. kidney and urinary tract infections with CC (59.71%), intracranial hemorrhage or cerebral infarction (53.33), and pulmonary edema and respiratory failure (47.47%). Our study highlights the economic burden during the COVID-19 pandemic on the hospital system in Italy based on individual patient data. These results contribute to the to the debate around the efficiency of the healthcare services provision during a pandemic.

Background Colonoscopy is one of the most frequently performed medical procedures worldwide, yet incomplete examinations remain common, leading to higher costs and delay in diagnosis and therapy. When a colonoscopy is not finished, a second procedure is recommended to complete the exploration of the large bowel such as another optical colonoscopy or virtual colonoscopy. Endorail ® is a medical device accessory for colonoscopes, based on magnetic balloon technology, developed to facilitate colonoscopy completion. This study reports an early budget impact analysis to quantify the short-term financial impact on hospital and National Healthcare System (NHS) budgets considering the introduction of this innovative technology in the routine clinical practice. Methods We estimated the budget impact of using Endorail for the management of colonoscopies that would be declared incomplete according to the standard of care (SoC), in the clinical practice in Italy over the first five years of commercialization. The hospital perspective considered a micro-costing analysis, while the NHS perspective considered the national reimbursement rates for healthcare services and the costs due to possible diagnostic delays in patients with colon cancer. Results Diagnostic pathway per-patient costs for Endorail strategy (hospital perspective 252.97 €, NHS perspective 132.75 €) showed slight savings compared to SoC (hospital perspective 255.89 €, NHS perspective 138.63 €). Increasing the use of the device from 2% to 10% of incomplete colonoscopies in five years could lead to savings at national level of 633,449 € and 856,286 €, respectively in the hospital and NHS perspective. Savings occur already during the first year and are mainly due to avoided second procedures. The sensitivity analyses, by varying the model parameters, showed savings at national level up to 1,691,686 €. Conclusions The early budget impact analysis indicates that Endorail can be considered a cost-neutral strategy for both hospital and NHS perspectives in Italy. Per-patient differences slightly favor Endorail, and a gradual increase in its use yields modest national savings that begin in the first year. In view of the model’s limitations, further research is required to validate the results and evaluate additional economic, organizational, and environmental effects. Moreover, evaluating patient perspectives and preferences may reveal further benefits of the technology, which is designed to improve both patient outcomes and experience by shortening procedure time, reducing discomfort, and minimizing the need for repeat examinations.

This paper presents a comparative analysis of value-based frameworks (VBFs) developed in the United States and Europe for both drugs and medical devices. The authors relied on a comprehensive literature review to identify relevant dimensions of analysis and available VBFs. Compared to previous studies on this topic, this study focused on the roles and strategic objectives of different institutions and organizations currently orchestrating the debate and development of VBFs and value-based initiatives. Among several projects and initiatives aimed at measuring value in health care, the study identified and analyzed in detail 7 VBFs. Different frameworks not only reflect different conceptions of value, but also different strategic objectives for which value needs to be measured: influencing clinical decision making, informing health care policies, affecting reimbursement, and pricing mechanisms or driving industry developments. Ultimately, all of these objectives represent different levers for fostering value-based treatment choices, but their different routes imply the assignment of key responsibilities to different actors within health care: medical professionals, patients, policymakers, payers, and medical technology and pharmaceutical companies. The proliferation of frameworks used for measuring the value of different health care objects and processes seems certainly a worthy exercise, but a real paradigm shift toward value-based care could only happen if these tools will be systematically used in practice and if all of these levers are played together, with joint actions and shared awareness of the key stakeholders' groups.