Approaches to Evaluations of Virtual Care in Primary Care

A literature search informed this Environmental Scan and identified 11 evaluations of virtual care in primary care health settings and 7 publications alluding to methods, standards, and guidelines (referred to as evaluation guidance documents in this report) being used in various countries to evaluate virtual care in primary care health settings. The majority of included literature was from Australia, the US, and the UK, with 2 evaluation guidance documents published by the Heart and Stroke Foundation of Canada. Evaluation guidance documents recommended using measurements that assess the effectiveness and quality of clinical care including safety outcomes, time and travel, financial and operational impact, participation, health care utilization, technology experience including feasibility, user satisfaction, and barriers and facilitators or measures of health equity. Evaluation guidance documents specified that the following key decisions and considerations should be integrated into the planning of a virtual care evaluation: refining the scope of virtual care services; selecting an appropriate meaningful comparator; and identifying opportune timing and duration for the evaluation to ensure the evaluation is reflective of real-world practice, allows for adequate measurement of outcomes, and is comprehensive, timely, feasible, non-complex, and non–resource-intensive. Evaluation guidance documents highlighted that evaluations should be systematic, performed regularly, and reflect the stage of virtual care implementation to encompass the specific considerations associated with each stage. Additionally, evaluations should assess individual virtual care sessions and the virtual care program as a whole. Regarding economic components of virtual care evaluations, the evaluation guidance documents noted that costs or savings are not limited to monetary or financial measures but can also be represented with time. Cost analyses such as cost-benefit and cost-utility estimates should be performed with a specific emphasis on selecting an appropriate perspective (e.g., patient or provider), as that influences the benefits, effects, and how the outcome is interpreted. Two identified evaluations assessed economic outcomes through cost analyses in the perspective of the patient and provider. Evidence suggests that, in some circumstances, virtual care may be more cost-effective and reduces the cost per episode and patient expenses (e.g., travel and parking costs) compared to in-person care. However, virtual care may increase the number of individuals treated, which would increase overall health care spending. Four identified evaluations assessed health care utilization. The evidence suggests that virtual care reduces the duration of appointments and may be more time-efficient compared to in-person care. However, it is unclear if virtual care reduces the use of medical resources and the need for follow-up appointments, hospital admissions, and emergency department visits compared to in-person care. Five identified evaluations assessed participation outcomes. Evidence was variable, with some evidence reporting that virtual care reduced attendance (e.g., reduced attendance rates) and other evidence noting improved attendance (e.g., increased completion rate and decreased cancellations and no-show rates) compared to in-person care. Three identified evaluations assessed clinical outcomes in various health contexts. Some evidence suggested that virtual care improves clinical outcomes (e.g., in primary care with integrated mental health services, symptom severity decreased) or has a similar effect on clinical outcomes compared to in-person care (e.g., use of virtual care in depression elicited similar results with in-person care). Three identified evaluations assessed the appropriateness of prescribing. Some studies suggested that virtual care improves appropriateness by increasing guideline-based or guideline-concordant antibiotic management, or elicits no difference with in-person care.

Developing a Prenatal Nutrition Tool: A Process of Evidence, Collaboration, and Consultation

The Prenatal Nutrition Tool was created for care providers that work with pregnant clients and aims to support focused conversations on nutrition topics that influence maternal and infant health outcomes. A systematic 9-step product development process that combined findings from the literature with perspectives of nutrition experts and care providers was used to develop the tool. The results of a literature review and a modified Delphi Process (to obtain expert opinion) laid the foundation for the tool content. The final tool incorporated client feedback. More specifically, client feedback helped to refine tool questions. The tool consists of 2 parts: a questionnaire (written survey) and a conversation guide. The questionnaire covers 4 key themes (pregnancy weight gain, multivitamins, life circumstances, overall food intake) in 13 questions. The conversation guide utilizes public health nutrition guidance documents to lead care providers in focused discussions with clients. The tool is not intended to be a screening tool for medical conditions or replace an in-depth prenatal nutrition assessment. The tool can be accessed by any care provider in Canada on the Alberta Health Services website at Prenatal Nutrition Tool | Alberta Health Services .

Moving From Evidence To Decisions in Guidelines: An Analysis of Guidance Documents

Background The process of moving from evidence to decisions (EtD) represents a cornerstone within guideline development methods. Little is known about the processes used by organizations in charge of guideline development and what criteria they consider when formulating recommendations. Objective To identify and describe the processes suggested for the formulation of healthcare recommendations in health care guidelines available in guidance documents. Methods We searched in spring 2020 the Guidelines International Network (G-I-N) website, MEDLINE, and The Cochrane Methodology Register to retrieve guidance documents published in the last decade by organizations dedicated to guideline development. Pairs of researchers independently selected and extracted data about the characteristics of the guidance document, including explicit or implicit recommendation-related criteria and processes considered, as well as the use of frameworks. We conducted both descriptive and bivariate analyses. Results We included 68 guidance documents, published mostly by scientific societies (58%). Most of the organizations reported a system for grading the strength of recommendations (88%), half of them being the GRADE approach. Two out of three guidance documents (66%) proposed the use of a framework to guide the EtD process. We identified 14 recommendation-related criteria. The GRADE Evidence to Decision (GRADE-EtD) framework was the most often reported framework (19 organizations, 42%), whereas 20 organizations (44%) proposed their own multi-criteria frameworks. Using any EtD framework was related with a more comprehensive set of recommendation-related criteria compared to no framework, especially for criteria like values, equity, and acceptability. A similar association was observed between the GRADE-EtD framework and either no framework or another EtD frameworks. Conclusion The use of systematic and structured processes for moving from evidence to decisions is still limited among international organizations. The use of EtD frameworks facilitates the inclusion of relevant recommendation criteria. Among the structured frameworks, the GRADE-EtD framework offers the most comprehensive perspective for evidence-informed decision-making processes. More complete and detailed reporting in the guidance documents is warranted.

Ethics as attention to context: recommendations for the ethics of artificial intelligence

This article shows that current ethics guidance documents and initiatives for artificial intelligence (AI) tend to be dominated by a principled approach to ethics. Although this brings value to the field, it also entails some risks, especially in relation to the abstraction of this form of ethics that makes it poorly equipped to engage with and address deep socio-political issues and the material impacts of AI. This is particularly problematic considering the risk for AI to further entrench already existing social inequalities and injustices and contribute to environmental damage. To respond to this challenge posed by AI ethics today, this article proposes to complement the existing principled approach with an approach to ethics as attention to context and relations. It does so by drawing from alternative ethical theories to the dominant principled one, especially the ethics of care or other feminist approaches to ethics. Related to this, it encourages the inclusion of social sciences and humanities in the development, deployment and use of AI, as well as in AI ethics discussions and initiatives. This article presents this proposal for an ethics as attention to context and formulates a series of practical recommendations to implement this proposal concretely.

PP205 The Use Of Real-World Evidence To Support National Institute For Health And Care Excellence Medical Technology Submissions

IntroductionAlthough randomized controlled trials (RCTs) are recognized as providing the highest level of clinical evidence, few medical device RCTs are available due to underfunding or inherent challenges associated with trial design. This study examines the extent to which real-world evidence (RWE) supports the recommendations made by the National Institute for Health and Care Excellence Medical Technologies Evaluation Programme (MTEP).MethodsAll MTEP guidance documents published online prior to October 2020 were reviewed. The “case for adoption” recommendation, type of clinical data, and clinical critiques for each MTEP submission were extracted and categorized. RWE was defined as studies with neither blinding nor prospective selection or control of patient characteristics.ResultsOf the MTEP submissions reviewed, 34 of 45 (76%) received a positive recommendation. Independent of outcome, all submissions included RWE, but only 19 (42%) utilized RCT evidence (15 were recommended and four were not). Meta-analyses of RWE were used whenever possible. The most common clinical critiques in unsuccessful submissions were the following: (i) not generalizable to the United Kingdom National Health Service (NHS); (ii) low quality; (iii) likelihood of bias; (iv) trial design faults; (v) uncertain benefit; and (vi) evidence unrelated to scope.ConclusionsThis study suggests that while the use of RCTs has not always led to a positive recommendation, RWE can be valuable in decision-making. Evidence that is generalizable to the NHS, is related to the scope, and shows clear indication of benefit is more likely to positively influence MTEP decision-making.

Determination the rational locations of territorial emergency response teams in the area of possible emergency situations of natural and technogenic nature

Due to frequent emergency cases at hazardous production facilities, which can lead to an environmental disaster, material and social damage, the issue of using the rational locations of territorial emergency response teams in the area of responsibility is the most relevant. The greatest weight if it is necessary to determine the rational place for the permanent deployment of territorial emergency rescue units created by the state authorities of the subject of the Russian Federation. Due to the lack of guidance documents and methodological recommendations for determining the permanent location of territorial emergency rescue units, this task was solved in each constituent entity of the Russian Federation in its own way and with a significant degree of subjectivity. It is proposed to use an algorithm for determining the permanent location of the rescue formation in the area of responsibility based on the probability of calling the formation to incidents, accidents and emergencies.

Time to inclusion in clinical guidance documents for non-oncological orphan drugs and biologics with expedited FDA designations: a retrospective survival analysis

ObjectivesDrug and biological products that treat rare, serious or life-threatening conditions can receive US Food and Drug Administration (FDA) orphan designation and expedited programme designations (accelerated approval, breakthrough therapy, fast track or priority review) meant to incentivise development. Timely recommendations from guidance documents may encourage more rapid and appropriate use and access to these medicines for serious conditions. We sought to determine time between FDA approval and inclusion in guidance documents for non-oncological orphan products overall and by number and type of expedited programme designations.Design and settingRetrospective survival analysis of non-oncological orphan products with ≥1 expedited designation approved since 1992. In June 2020, PubMed, Turning Research into Practice and Guideline Central databases were searched to identify guidance documents influencing US practice that included each product.Main outcomes and measuresThe primary outcome was time to guidance inclusion, defined as any recommendation on use provided within the recommendation framework used by the guidance document.ResultsAmong 135 included non-oncological orphan products, 97.0% (n=131) were designated with priority review, 49.6% (n=67) fast track, 16.3% (n=22) breakthrough therapy and 14.1% (n=19) accelerated approval. Sixty per cent of products (n=81) received ≥2 designations. Overall, 74.1% (n=100) were included in a guidance document. The median time to inclusion was 2.87 years (IQR 2.21–4.18) for the entire cohort. In survival analyses, guidance inclusion was more likely to occur earlier for products with ≥2 designations (HR, 1.84; 95% CI 1.21 to 2.79) and for those with fast-track designation compared with priority review (HR 1.40; 95% CI 1.02 to 2.0). Of 35 products not included in a guidance document, 54.3% (n=19) were approved in 2018 or later.ConclusionsAmong non-oncological orphan products with priority designations, nearly 3 years had passed between FDA approval and inclusion in any guidance document. These findings suggest that despite efforts to expedite availability, appropriate access to these treatments may be delayed because of the lack of timely guidance on their use in clinical practice.

COVID-19 management in social care in England: a systematic review of changing policies and newspaper reported staff perspectives.

Adult social care has been a major focus of public attention and infection control guidance during the COVID-19 pandemic, with a high mortality both for carers and those receiving care. To protect themselves and others from infection, staff in residential and domiciliary care settings had to quickly adapt to infection control measures that heavily impacted on their working and every-day life, whilst navigating new responsibilities, uncertainties and anxieties. We sought to explore the production and reception of guidance and look at ways these can be adapted to improve the working life of care staff in domiciliary and residential care whilst reducing the risk of SARS-CoV-2 transmission amid this pandemic and of future emerging infections. We conducted two complementary and integrated systematic reviews of published documents in the pre-vaccination era: (1) National guidance for social care (conducted between 29 July to 28 October 2020), and (2) Newspaper coverage of infection control issues in social care (conducted between 27th July to 10th September 2020). Three higher order common themes emerged in the integrated systematic review of guidance documents and newspaper articles: a) Testing, b) Personal Protective Equipment, c) Employment. The reviews revealed a sharp disjunction between the content of infection control guidance and its usability and applicability in social care settings. We suggest that infection control guidance needs to be better adapted to social care settings and informed by the sector. The practicalities of care work and care settings need to be at the core of the process for guidance to be relevant and effective. Modes and timings of communications also need to be optimised.

Use of COVID-19 evidence in humanitarian settings: the need for dynamic guidance adapted to changing humanitarian crisis contexts

Background For humanitarian organisations to respond effectively to complex crises, they require access to up-to-date evidence-based guidance. The COVID-19 crisis has highlighted the importance of updating global guidance to context-specific and evolving needs in humanitarian settings. Our study aimed to understand the use of evidence-based guidance in humanitarian responses during COVID-19. Primary data collected during the rapidly evolving pandemic sheds new light on evidence-use processes in humanitarian response. Methods We collected and analysed COVID-19 guidance documents, and conducted semi-structured interviews remotely with a variety of humanitarian organisations responding and adapting to the COVID-19 pandemic. We used the COVID-19 Humanitarian platform, a website established by three universities in March 2020, to solicit, collate and document these experiences and knowledge. Results We analysed 131 guidance documents and conducted 80 interviews with humanitarian organisations, generating 61 published field experiences. Although COVID-19 guidance was quickly developed and disseminated in the initial phases of the crisis (from January to May 2020), updates or ongoing revision of the guidance has been limited. Interviews conducted between April and September 2020 showed that humanitarian organisations have responded to COVID-19 in innovative and context-specific ways, but have often had to adapt existing guidance to inform their operations in complex humanitarian settings. Conclusions Experiences from the field indicate that humanitarian organisations consulted guidance to respond and adapt to COVID-19, but whether referring to available guidance indicates evidence use depends on its accessibility, coherence, contextual relevance and trustworthiness. Feedback loops through online platforms like the COVID-19 Humanitarian platform that relay details of these evidence-use processes to global guidance setters could improve future humanitarian response.

GI Guidelines for the Metropolitan City of Cagliari (Italy): A Method for Implementing Green Areas

The decline of natural capital resulting from urbanization has triggered phenomena such as landscape fragmentation and loss of biodiversity. European institutions have published documents and strategies with the purpose of counteracting such phenomena. In this regard, in 2020 the European Commission released the European Biodiversity Strategy 2030, which defines biodiversity conservation objectives and promotes the implementation of green infrastructures (GIs) designed to supply ecosystem services, which can increase people’s well-being. The scientific literature has scarcely dealt with methods for drafting guidance documents (guidelines) to support public administrations in the implementation of GIs. In this study, we aim at designing and applying a method for drafting GI guidelines. We apply the method to the Metropolitan City of Cagliari, the main urbanized area—which partially includes the former Province of Cagliari—of Sardinia (Italy). According to the findings, a proposal of GI guidelines should be rooted in context analysis and consistency checks and should be tailored to specific geographical and institutional contexts. The preliminary guidelines described in this study are designed to provide public administrations with GI guidelines based on scientific, technical, and cultural considerations, and are aimed at supporting an effective implementation of GIs and a GI network.