BACKGROUND: Internationally, patient-accessible electronic health records (PAEHRs) are increasingly being implemented. Despite reported benefits to patients, the innovation has prompted concerns among health care professionals (HCPs), including the possibility that access incurs a \"dumbing down\" of clinical records. Currently, no review has investigated empirical evidence of whether and how documentation changes after introducing PAEHRs.
OBJECTIVE: This paper presents the protocol for a scoping review examining potential subjective and objective changes in HCPs documentation after using PAEHRs.
METHODS: This scoping review will be carried out based on the framework of Arksey and O\'Malley. Several databases will be used to conduct a literature search (APA PsycInfo, CINAHL, PubMed, and Web of Science Core Collection). Authors will participate in screening identified papers to explore the research questions: How do PAEHRs affect HCPs\' documentation practices? and What subjective and objective changes to the clinical notes arise after patient access? Only studies that relate to actual use experiences, and not merely prior expectations about PAEHRs, will be selected in the review. Data abstraction will include but will not be limited to publication type, publication year, country, sample characteristics, setting, study aim, research question, and conclusions. The Mixed Methods Appraisal Tool will be used to assess the quality of the studies included.
RESULTS: The results from this scoping review will be presented as a narrative synthesis structured along the key themes of the corpus of evidence. Additional data will be prepared in charts or tabular format. We anticipate the results to be presented in a scoping review at a later date. They will be disseminated at scientific conferences and through publication in a peer-reviewed journal.
CONCLUSIONS: This is the first scoping review that considers potential change in documentation after implementation of PAEHRs. The results can potentially help affirm or refute prior opinions and expectations among various stakeholders about the use of PAEHRs and thereby help to address uncertainties. Results may help to provide guidance to clinicians in writing notes and thus have immediate practical relevance to care. In addition, the review will help to identify any substantive research gaps in this field of research. In the longer term, our findings may contribute to the development of shared documentation guidelines, which in turn are central to improving patient communication and safety.
UNASSIGNED: PRR1-10.2196/46722.

Background: Prostate cancer is the second most common cancer in men, with up to one-third of men being diagnosed in their lifetime. Recently, novel therapies have received regulatory approval with significant improvement in overall survival for metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and nonmetastatic castration-resistant prostate cancer. To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). Objective: This review aimed to map HTA status, reimbursement restrictions, and patient access for 3 advanced prostate cancer indications across 23 European countries during 2011-2021. Methods: HTA, country reimbursement lists, and ESMO-MCBS scorecards were reviewed for evidence and data across 26 European countries. Results: The analysis demonstrated that only in Greece, Germany, and Sweden was there full access across all included prostate cancer treatments. Treatments available for metastatic castration-resistant prostate cancer were widely reimbursed, with both abiraterone and enzalutamide accessible in all countries. In 3 countries (Hungary, the Netherlands, and Switzerland), there was a statistically significant difference (P<.05) between status of reimbursement and ESMO-MCBS \"substantial benefit\" (score of 4 or 5) vs \"no substantial benefit\" (score <4). Conclusion: Overall, the impact of the ESMO-MCBS on reimbursement decisions in Europe is unclear, with significant variation across the countries included in this review.

Ongoing efforts worldwide to provide patients with patient-accessible electronic health records (PAEHRs) have led to variability in adolescent and parental access across providers, regions, and countries. There is no compilation of evidence to guide policy decisions in matters such as access age and the extent of parent proxy access. In this paper, we outline our scoping review of different stakeholders\' (including but not limited to end users) views, use, and experiences pertaining to web-based access to electronic health records (EHRs) by children, adolescents, and parents.
The aim of this study was to identify, categorize, and summarize knowledge about different stakeholders\' (eg, children and adolescents, parents, health care professionals [HCPs], policy makers, and designers of patient portals or PAEHRs) views, use, and experiences of EHR access for children, adolescents, and parents.
A scoping review was conducted according to the Arksey and O\'Malley framework. A literature search identified eligible papers that focused on EHR access for children, adolescents, and parents that were published between 2007 and 2021. A number of databases were used to search for literature (PubMed, CINAHL, and PsycINFO).
The approach resulted in 4817 identified articles and 74 (1.54%) included articles. The papers were predominantly viewpoints based in the United States, and the number of studies on parents was larger than that on adolescents and HCPs combined. First, adolescents and parents without access anticipated low literacy and confidentiality issues; however, adolescents and parents who had accessed their records did not report such concerns. Second, the main issue for HCPs was maintaining adolescent confidentiality. This remained an issue after using PAEHRs for parents, HCPs, and other stakeholders but was not an experienced issue for adolescents. Third, the viewpoints of other stakeholders provided a number of suggestions to mitigate issues. Finally, education is needed for adolescents, parents, and HCPs.
There is limited research on pediatric PAEHRs, particularly outside the United States, and on adolescents\' experiences with web-based access to their records. These findings could inform the design and implementation of future regulations regarding access to PAEHRs. Further examination is warranted on the experiences of adolescents, parents, and HCPs to improve usability and utility, inform universal principles reducing the current arbitrariness in the child\'s age for own and parental access to EHRs among providers worldwide, and ensure that portals are equipped to safely and appropriately manage a wide variety of patient circumstances.
RR2-10.2196/36158.

Approaches to routine vaccine funding and the underlying budget-setting process vary greatly across European countries. The ongoing COVID-19 pandemic has put enormous pressure on healthcare systems, affecting resilience of the overall vaccine ecosystem.
This article reviews how vaccine budgets are structured across 8 European countries (England, Finland, France, Germany, Italy, Norway, Romania, and Spain). First a literature review of the landscape was undertaken, followed by expert interviews to review the findings and consider policy principles to secure prioritisation and sustainability of routine vaccination budgets post-COVID.
The organisation of budgets and vaccine spending varies greatly across Europe. In 2/8 countries (France and Germany) vaccine spending is subsumed into a wider healthcare budget. In 2/8 countries (Italy and Romania) the budget differentiates public health and prevention spending from other areas of healthcare, though there is no standalone vaccine budget. In 4/8 countries (England, Finland, Norway and Spain) there is a standalone vaccine budget, however this may not cover all elements needed for immunisation delivery and is not always transparent.
Ensuring adequate and dynamic country vaccine budgets, with horizon scanning approaches like in England and Finland, or flexible vaccines expenditures like Germany, would greatly help the timely availability of public funding for new vaccines and strengthen vaccines supply security in Europe through a more virtuous European vaccine ecosystem.

BACKGROUND: As patient online access to electronic health records becomes the standard, implementation of access for adolescents and parents varies across providers, regions, and countries. There is currently no international compilation of evidence to guide policy decisions in matters such as age limit for access and the extent of parent proxy access.
OBJECTIVE: This paper presents the protocol for a scoping review of different stakeholders\' (including but not limited to end users) perspectives on use, opinions, and experiences pertaining to online access to electronic health records by parents, children, and adolescents.
METHODS: This scoping review will be conducted according to the Arksey and O\'Malley framework. Several databases will be used to conduct a literature search (PubMed, CINAHL, and PsycInfo), in addition to literature found outside of these databases. All authors will participate in screening identified papers, following the research question: How do different stakeholders experience parents\', children\'s, and adolescents\' online access to the electronic health records of children and adolescents? Data abstraction will include but will not be limited to publication type, publication year, country, sample characteristics, setting, study aim, research question, and conclusions. The data to be analyzed are from publicly available secondary sources, so this study does not require an ethics review.
RESULTS: The results from this scoping review will be presented in a narrative form, and additional data on study characteristics will be presented in diagrams or tabular format. This scoping review protocol was first initiated by Uppsala University in June 2021 as part of the NordForsk-funded research project NORDeHEALTH. The results are expected to be presented in a scoping review in June 2022. The results will be disseminated through stakeholder meetings, scientific conference presentations, oral presentations to the public, and publication in a peer-reviewed journal.
CONCLUSIONS: This is, to our knowledge, the first study to map the literature on the use and experiences of parents\' and adolescents\' online access to the electronic health records of children and adolescents. The findings will describe what benefits and risks have been experienced by different stakeholders so far in different countries. A mapping of studies could inform the design and implementation of future regulations around access to patient-accessible electronic health records.
UNASSIGNED: DERR1-10.2196/36158.

UNASSIGNED: The onset of the COVID-19 pandemic in March of 2020 forced a rapid pivot to telehealth and compelled a use-case experiment in specialty telehealth neurology movement disorders care. The aims of this study were to quantify the potential benefit of telehealth as an option to the Parkinson\'s disease community as shown by the first 9 months of the COVID-19 pandemic, and to quantify the potential impact of the absence of a deep brain stimulation (DBS) telehealth option on DBS patient follow-up.
UNASSIGNED: New patient visits to the Inova Parkinson\'s and Movement Disorder\'s Center from April to December 2020 (9 months) were retrospectively reviewed for telehealth vs. in-person, demographics (age, gender, race, primary insurance), chief complaint, prior movement disorders specialist (MDS) consultation, imaging tests ordered, and distance/travel time from primary zip code to clinic. Additionally, DBS programming visit volume from April to December 2020 was compared to DBS programming visit volume from April to December 2019.
UNASSIGNED: Of the 1,097 new patients seen, 85% were via telehealth (N = 932) and 15% in person (N = 165). In the telehealth cohort, 97.75% had not consulted with an MDS before (N = 911), vs. 87.9% of in-person (N = 145). Age range was 61.8 +/- 17.9 years (telehealth), 68.8 +/- 16.0 years (in-person). Racial breakdown for telehealth was 60.7% White (N = 566), 10.4% Black (N = 97), 7.4% Asian (N = 69) and 4.5% Hispanic (N = 42); in-person was 70.9% White (N = 117), 5.5% Black (N = 9), 7.9% Asian (N = 13) and 5.5% Hispanic (N = 9). Top 5 consultation reasons, top 10 primary insurance providers and imaging studies ordered between the two cohorts were similar. Distance/travel time between primary zip code and clinic were 33.8 +/- 104.8 miles and 42.2 +/- 93.4 min (telehealth) vs. 38.1 +/- 114.7 miles and 44.1 +/- 97.6 min (in-person). DBS programming visits dropped 24.8% compared to the same period the year before (254 visits to 191 visits).
UNASSIGNED: Telehealth-based new patient visits to a Movement Disorders Center appeared successful at increasing access to specialty care. The minimal difference in supporting data highlights the potential parity to in-person visits. With no telehealth option for DBS visits, a significant drop-off was seen in routine DBS management.

Patient access to their own electronic health records (EHRs) is likely to become an integral part of healthcare systems worldwide. It has the potential to decrease the healthcare provision costs, improve access to healthcare data, self-care, quality of care, and health and patient-centered outcomes. This systematic literature review is aimed at identifying the impact in terms of benefits and issues that have so far been demonstrated by providing patients access to their own EHRs, via providers\' secure patient portals from primary healthcare centers and hospitals. Searches were conducted in PubMed, MEDLINE, CINHAL, and Google scholar. Over 2000 papers were screened and were filtered based on duplicates, then by reading the titles and finally based on their abstracts or full text. In total, 74 papers were retained, analyzed, and summarized. Papers were included if providing patient access to their own EHRs was the primary intervention used in the study and its impact or outcome was evaluated. The search technique used to identify relevant literature for this paper involved input from five experts. While findings from 54 of the 74 papers showed positive outcome or benefits of patient access to their EHRs via patient portals, 10 papers have highlighted concerns, 8 papers have highlighted both and 2 have highlighted absence of negative outcomes. The benefits range from re-assurance, reduced anxiety, positive impact on consultations, better doctor-patient relationship, increased awareness and adherence to medication, and improved patient outcomes (e.g., improving blood pressure and glycemic control in a range of study populations). In addition, patient access to their health information was found to improve self-reported levels of engagement or activation related to self-management, enhanced knowledge, and improve recovery scores, and organizational efficiencies in a tertiary level mental health care facility. However, three studies did not find any statistically significant effect of patient portals on health outcomes. The main concerns have been around security, privacy and confidentiality of the health records, and the anxiety it may cause amongst patients. This literature review identified some benefits, concerns, and attitudes demonstrated by providing patients\' access to their own EHRs. This access is often part of government strategies when developing patient-centric self-management elements of a sustainable healthcare system. The findings of this review will give healthcare providers a framework to analyze the benefits offered by promoting patient access to EHRs and decide on the best approach for their own specialties and clinical setup. A robust cost-benefit evaluation of such initiatives along with its impact on major stakeholders within the healthcare system would be essential in understanding the overall impact of such initiatives. Implementation of patient access to their EHRs could help governments to appropriately prioritize the development or adoption of national standards, whilst taking care of local variations and fulfilling the healthcare needs of the population, e.g., UK Government is aiming to make full primary care records available online to every patient. Ultimately, increasing transparency and promoting personal responsibility are key elements of a sustainable healthcare system for future generations.

Objective: This study aims to provide an up-to-date analysis of the current state of patient access to new drugs in South Korea, focusing on the effect of new review pathways for reimbursement. Methods: We analyzed patients\' access to new drugs, listing rate and lead time until listing from marketing authorization. New pathways were defined as \'price negotiation waiver,\' \'risk-sharing agreements,\' and \'pharmacoeconomic evaluation exemption.\' Results: The listing rate for drugs increased after the introduction of the new pathways (93.7% vs. 77.9%, p < 0.001). Before the new pathways, the median lead time for listing was 21.0 months (95% CI: 16.9-25.0), while afterward it was shortened to 10.9 months (95% CI: 10.2-11.7) (p < 0.001). Conclusion: Although it has strengthened national health insurance coverage by positively impacting the rate and lead time, the lead time for the oncology and orphan drugs is substantially longer as compared to other drugs. Expanding the eligibility criteria to include non-life-threatening but rare or intractable diseases, and resolving the system\'s operational issues are still necessary.

A large number of medical devices (MDs) is available in Europe. Procedures for market approval and reimbursement have been adopted over recent years to promote accelerating patient access to innovative MDs. However, there remains uncertainty and non-transparency regarding these procedures. We provide a structured overview of market approval and reimbursement procedures and practices regarding access to MDs in the EU. Market approval procedures were found to be uniformly described. Data on reimbursement procedures and practices was both heterogeneous and incomplete. Time to MD access was mainly determined by reimbursement procedures. The influence of the patient on time to access was not reported. Prescription practices varied among device types. Barriers to and facilitators of early patient access that set the agenda for policy implications were also analyzed. Barriers were caused by unclear European legislation, complex market approval procedures, lack of data collection, inconsistency in evidence requirements between countries, regional reimbursement and provision, and factors influencing physicians\' prescription including the device costs, waiting times and hospital-physician relationships. Facilitators were: available evidence that meets country-specific requirements for reimbursement, diagnosis-related groups, additional payments and research programs. Further research needs to focus on creating a complete overview of reimbursement procedures and practices by extracting further information from sources such as grey literature and interviews with professionals, and defining clear criteria to objectify time to access.

While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies. Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars. References of included papers were also scrutinized. After a title-, abstract- and full text screening, out of the 153 original hits and 77 additional ones from screening the references, 58 papers (12 empirical papers, 5 systematic reviews and 41 non-empirical papers) were included. Expert opinion: Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access. Indeed, it is the opinion of the authors that the concern of switching to biosimilars is overhyped.