The Impact of Virtual Consultations on the Quality of Primary Care: Systematic Review.

BACKGROUND: The adoption of virtual consultations, catalyzed by the COVID-19 pandemic, has transformed the delivery of primary care services. Owing to their rapid global proliferation, there is a need to comprehensively evaluate the impact of virtual consultations on all aspects of care quality. OBJECTIVE: This study aims to evaluate the impact of virtual consultations on the quality of primary care. METHODS: A total of 6 databases were searched. Studies that evaluated the impact of virtual consultations, for any disease, were included. Title and abstract screening and full-text screening were performed by 2 pairs of investigators. Risk of bias was assessed using the Mixed Methods Appraisal Tool. A narrative synthesis of the results was performed. RESULTS: In total, 30 studies (5,469,333 participants) were included in this review. Our findings suggest that virtual consultations are equally effective to or more effective than face-to-face care for the management of certain conditions, including mental illness, excessive smoking, and alcohol consumption. Overall, 4 studies indicated positive impacts on some aspects of patient-centeredness; however, a negative impact was noted on patients' perceived autonomy support (ie, the degree to which people perceive those in positions of authority to be autonomy supportive). Virtual consultations may reduce waiting times, lower patient costs, and reduce rates of follow-up in secondary and tertiary care settings. Evidence for the impact on clinical safety is extremely limited. Evidence regarding equity was considerably mixed. Overall, it appears that virtual care is more likely to be used by younger, female patients, with disparities among other subgroups depending on contextual factors. CONCLUSIONS: Our systematic review demonstrated that virtual consultations may be as effective as face-to-face care and have a potentially positive impact on the efficiency and timeliness of care; however, there is a considerable lack of evidence on the impacts on patient safety, equity, and patient-centeredness, highlighting areas where future research efforts should be devoted. Capitalizing on real-world data, as well as clinical trials, is crucial to ensure that the use of virtual consultations is tailored according to patient needs and is inclusive of the intended end users. Data collection methods that are bespoke to the primary care context and account for patient characteristics are necessary to generate a stronger evidence base to inform future virtual care policies.

Strengths, Weaknesses, Opportunities, and Threats Analysis of the Use of Digital Health Technologies in Primary Health Care in the Sub-Saharan African Region: Qualitative Study.

BACKGROUND: Digital health technologies (DHTs) have become increasingly commonplace as a means of delivering primary care. While DHTs have been postulated to reduce inequalities, increase access, and strengthen health systems, how the implementation of DHTs has been realized in the sub-Saharan Africa (SSA) health care environment remains inadequately explored. OBJECTIVE: This study aims to capture the multidisciplinary experiences of primary care professionals using DHTs to explore the strengths and weaknesses, as well as opportunities and threats, regarding the implementation and use of DHTs in SSA primary care settings. METHODS: A combination of qualitative approaches was adopted (ie, focus groups and semistructured interviews). Participants were recruited through the African Forum for Primary Care and researchers' contact networks using convenience sampling and included if having experience with digital technologies in primary health care in SSA. Focus and interviews were conducted, respectively, in November 2021 and January-March 2022. Topic guides were used to cover relevant topics in the interviews, using the strengths, weaknesses, opportunities, and threats framework. Transcripts were compiled verbatim and systematically reviewed by 2 independent reviewers using framework analysis to identify emerging themes. The COREQ (Consolidated Criteria for Reporting Qualitative Research) checklist was used to ensure the study met the recommended standards of qualitative data reporting. RESULTS: A total of 33 participants participated in the study (n=13 and n=23 in the interviews and in focus groups, respectively; n=3 participants participated in both). The strengths of using DHTs ranged from improving access to care, supporting the continuity of care, and increasing care satisfaction and trust to greater collaboration, enabling safer decision-making, and hastening progress toward universal health coverage. Weaknesses included poor digital literacy, health inequalities, lack of human resources, inadequate training, lack of basic infrastructure and equipment, and poor coordination when implementing DHTs. DHTs were perceived as an opportunity to improve patient digital literacy, increase equity, promote more patient-centric design in upcoming DHTs, streamline expenditure, and provide a means to learn international best practices. Threats identified include the lack of buy-in from both patients and providers, insufficient human resources and local capacity, inadequate governmental support, overly restrictive regulations, and a lack of focus on cybersecurity and data protection. CONCLUSIONS: The research highlights the complex challenges of implementing DHTs in the SSA context as a fast-moving health delivery modality, as well as the need for multistakeholder involvement. Future research should explore the nuances of these findings across different technologies and settings in the SSA region and implications on health and health care equity, capitalizing on mixed-methods research, including the use of real-world quantitative data to understand patient health needs. The promise of digital health will only be realized when informed by studies that incorporate patient perspective at every stage of the research cycle.

Health technology assessment and priority setting for universal health coverage: a qualitative study of stakeholders' capacity, needs, policy areas of demand and perspectives in Nigeria.

INTRODUCTION: Health technology assessment (HTA) is an effective tool to support priority setting and generate evidence for decision making especially en route to achieving universal health coverage (UHC). We assessed the capacity needs, policy areas of demand, and perspectives of key stakeholders for evidence-informed decision making in Nigeria where HTA is still new. METHODS: We surveyed 31 participants including decision makers, policy makers, academic researchers, civil society organizations, community-based organizations, development partners, health professional organizations. We revised an existing survey to qualitatively examine the need, policy areas of demand, and perspectives of stakeholders on HTA. We then analyzed responses and explored key themes. RESULTS: Most respondents were associated with organizations that generated or facilitated health services research. Research institutes highlighted their ability to provide expertise and skills for HTA research but some respondents noted a lack of human capacity for HTA. HTA was considered an important and valuable priority-setting tool with a key role in the design of health benefits packages, clinical guideline development, and service improvement. Public health programs, medicines and vaccines were the three main technology types that would especially benefit from the application of HTA. The perceived availability and accessibility of suitable local data to support HTA varied widely but was mostly considered inadequate and limited. Respondents needed evidence on health system financing, health service provision, burden of disease and noted a need for training support in research methodology, HTA and data management. CONCLUSION: The use of HTA by policymakers and communities in Nigeria is very limited mainly due to inadequate and insufficient capacity to produce and use HTA. Developing sustainable and institutionalized HTA systems requires in-country expertise and active participation from a range of stakeholders. Stakeholder participation in identifying HTA topics and conducting relevant research will enhance the use of HTA evidence produced for decision making. Therefore, the identified training needs for HTA and possible research topics should be considered a priority in establishing HTA for evidence-informed policy making for achieving UHC particularly among the most vulnerable people in Nigeria.

Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study.

BACKGROUND: Accelerated digitalization in the health sector requires the development of appropriate evaluation methods to ensure that digital health technologies (DHTs) are safe and effective. Software as a medical device (SaMD) is a commonly used DHT by clinicians to provide care to patients. Traditional research methods for evaluating health care products, such as randomized clinical trials, may not be suitable for DHTs, such as SaMD. However, evidence to show their safety and efficacy is needed by regulators before they can be used in practice. Clinical simulation can be used by researchers to test SaMD in an agile and low-cost way; yet, there is limited research on criteria to assess the robustness of simulations and, subsequently, their relevance for a regulatory decision. OBJECTIVE: The objective of this study was to gain consensus on the criteria that should be used to assess clinical simulation from a regulatory perspective when it is used to generate evidence for SaMD. METHODS: An eDelphi study approach was chosen to develop a set of criteria to assess clinical simulation when used to evaluate SaMD. Participants were recruited through purposive and snowball sampling based on their experience and knowledge in relevant sectors. They were guided through an initial scoping questionnaire with key themes identified from the literature to obtain a comprehensive list of criteria. Participants voted upon these criteria in 2 Delphi rounds, with criteria being excluded if consensus was not met. Participants were invited to add qualitative comments during rounds and qualitative analysis was performed on the comments gathered during the first round. Consensus was predefined by 2 criteria: if <10% of the panelists deemed the criteria as "not important" or "not important at all" and >60% "important" or "very important." RESULTS: In total, 33 international experts in the digital health field, including academics, regulators, policy makers, and industry representatives, completed both Delphi rounds, and 43 criteria gained consensus from the participants. The research team grouped these criteria into 7 domains-background and context, overall study design, study population, delivery of the simulation, fidelity, software and artificial intelligence, and study analysis. These 7 domains were formulated into the simulation for regulation of SaMD framework. There were key areas of concern identified by participants regarding the framework criteria, such as the importance of how simulation fidelity is achieved and reported and the avoidance of bias throughout all stages. CONCLUSIONS: This study proposes the simulation for regulation of SaMD framework, developed through an eDelphi consensus process, to evaluate clinical simulation when used to assess SaMD. Future research should prioritize the development of safe and effective SaMD, while implementing and refining the framework criteria to adapt to new challenges.

Usability and Feasibility Evaluation of a Web-Based and Offline Cybersecurity Resource for Health Care Organizations (The Essentials of Cybersecurity in Health Care Organizations Framework Resource): Mixed Methods Study.

BACKGROUND: Cybersecurity is a growing challenge for health systems worldwide as the rapid adoption of digital technologies has led to increased cyber vulnerabilities with implications for patients and health providers. It is critical to develop workforce awareness and training as part of a safety culture and continuous improvement within health care organizations. However, there are limited open-access, health care-specific resources to help organizations at different levels of maturity develop their cybersecurity practices. OBJECTIVE: This study aims to assess the usability and feasibility of the Essentials of Cybersecurity in Health Care Organizations (ECHO) framework resource and evaluate the strengths, weaknesses, opportunities, and threats associated with implementing the resource at the organizational level. METHODS: A mixed methods, cross-sectional study of the acceptability and usability of the ECHO framework resource was undertaken. The research model was developed based on the technology acceptance model. Members of the Imperial College Leading Health Systems Network and other health care organizations identified through the research teams' networks were invited to participate. Study data were collected through web-based surveys 1 month and 3 months from the date the ECHO framework resource was received by the participants. Quantitative data were analyzed using R software (version 4.2.1). Descriptive statistics were calculated using the mean and 95% CIs. To determine significant differences between the distribution of answers by comparing results from the 2 survey time points, 2-tailed t tests were used. Qualitative data were analyzed using Microsoft Excel. Thematic analysis used deductive and inductive approaches to capture themes and concepts. RESULTS: A total of 16 health care organizations participated in the study. The ECHO framework resource was well accepted and useful for health care organizations, improving their understanding of cybersecurity as a priority area, reducing threats, and enabling organizational planning. Although not all participants were able to implement the resource as part of information computing technology (ICT) cybersecurity activities, those who did were positive about the process of change. Learnings from the implementation process included the usefulness of the resource for raising awareness and ease of use based on familiarity with other standards, guidelines, and tools. Participants noted that several sections of the framework were difficult to operationalize due to costs or budget constraints, human resource limitations, leadership support, stakeholder engagement, and limited time. CONCLUSIONS: The research identified the acceptability and usability of the ECHO framework resource as a health-focused cybersecurity resource for health care organizations. As cybersecurity in health care organizations is everyone's responsibility, there is potential for the framework resource to be used by staff with varied job roles. Future research needs to explore how it can be updated for ICT staff and implemented in practice and how educational materials on different aspects of the framework could be developed.

Regional perspectives on patient safety policies and initiatives: a focus group study with patient safety leaders in the Middle East and Asian regions.

Preventing and reducing risks and harm to patients is of critical importance as unsafe care is a leading cause of death and disability globally. However, the lack of consolidated information on patient safety policies and initiatives at regional levels represents an evidence gap with implications for policy and planning. The aim of the study was to answer the question of what patient safety policies and initiatives are currently in place in the Middle East and Asian regions and what were the main strengths, weaknesses, opportunities and threats in developing these. A qualitative approach using online focus groups was adopted. Participants attended focus groups beginning in August 2022. A topic guide was developed using a strengths, weaknesses, opportunities and threats framework analysis approach. The Consolidated Criteria for Reporting Qualitative Research checklist was used to ensure the recommended standards of qualitative data reporting were met. 21 participants from 11 countries participated in the study. Current patient safety policies identified were categorised across 5 thematic areas and initiatives were categorised across a further 10 thematic areas. Strengths of patient safety initiatives included enabling healthcare worker training, leadership commitment in hospitals, and stakeholder engagement and collaboration. Weaknesses included a disconnect between health delivery and education, implementation gaps, low clinical awareness and buy-in at the facility level, and lack of leadership engagement. Just culture, safety by design and education were considered opportunities, alongside data collection and reporting for research and shared learning. Future threats were low leadership commitment, changing leadership, poor integration across the system, a public-private quality gap and political instability in some contexts. Undertaking further research regionally will enable shared learning and the development of best practice examples. Future research should explore the development of policies and initiatives for patient safety at the provider, local and national levels that can inform action across the system.

How NHS data could benefit us all and how to build the trust needed to make it happen.

The pandemic has accelerated the data-sharing conversation and patients are increasingly receptive to sharing data, but missteps in this area could undermine public trust. This article outlines public concerns, lessons learned from previous unsuccessful activities, and the potential for secure data environments, which will be vital for the UK to maximise benefits for patients and the NHS.

Identifying benefits and concerns with using digital health services during COVID-19: Evidence from a hospital-based patient survey.

Despite large-scale adoption during COVID-19, patient perceptions on the benefits and potential risks with receiving care through digital technologies have remained largely unexplored. A quantitative content analysis of responses to a questionnaire (N = 6766) conducted at a multi-site acute trust in London (UK), was adopted to identify commonly reported benefits and concerns. Patients reported a range of promising benefits beyond immediate usage during COVID-19, including ease of access; support for disease and care management; improved timeliness of access and treatment; and better prioritisation of healthcare resources. However, in addition to known risks such as data security and inequity in access, our findings also illuminate some less studied concerns, including perceptions of compromised safety; negative impacts on patient-clinician relationships; and difficulties in interpreting health information provided through electronic health records and mHealth apps. Implications for future research and practice are discussed.

Safety in fragile, conflict-affected, and vulnerable settings: An evidence scanning approach for identifying patient safety interventions.

Background: The number of people living in fragile, conflict-affected, and vulnerable (FCV) settings is growing rapidly and attention to achieving universal health coverage must be accompanied by sufficient focus on the safety of care for universal access to be meaningful. Healthcare workers in these settings are working under extreme conditions, often with insufficient contextualized evidence to support decision-making. Recognising the relative paucity of, and methodological issues in gathering evidence from these settings, the evidence scanning described in this paper considered which patient safety interventions might offer the 'better bet', eg, the most effective and appropriate intervention in FCV settings. Methods: An evidence scanning approach was used to examine the literature. The search was limited to FCV settings and low-income settings as defined by the World Bank, but if a systematic review included a mix of evidence from FCV/low income settings, as well as low-middle income settings, it was included. The search was conducted in English and limited to studies published from 2003 onwards, utilising Google Scholar as a publicly accessible database and further review of the grey literature, with specific attention to the outputs of non-governmental organisations. The search and subsequent analysis were completed between April and June 2020. Results: The majority of studies identified related to strengthening infection prevention and control which was also found to be the 'better bet' intervention that could generalise to other settings, be most feasible to implement, and most effective for improving patient care and associated outcomes. Other prioritized interventions include risk management, with contributing elements such as reporting, audits, and death review processes. Conclusions: Infection prevention and control interventions dominate in the literature for multiple reasons including strength of evidence, acceptability, feasibility, and impact on patient and health worker well-being. However, there is an urgent need to further develop the evidence base, specialist knowledge, and field guidance on a range of other patient safety interventions such as education and training, patient identification, subject specific safety actions, and risk management.

Lessons post-COVID from national and international approaches to safety and quality in healthcare.

The COVID-19 pandemic has been a challenge as well as an opportunity for healthcare. The pandemic has exposed the inherent weaknesses in health systems globally while, at the same time, revealing strengths on which post-pandemic health systems can be built. We propose lessons on improving quality and safety post-pandemic from a global perspective based on recent policy publications and our global experience. Nine possible lessons are discussed. These lessons can ensure that healthcare does not return to the old normal, but rather builds on what we have learnt as we deliver on the Sustainable Development Goals and universal health coverage. Quality and safety are an essential component of healthcare strategy. Post-pandemic systems require a transparent compassionate culture, with integration of care at its core. The workforce must be trained in the skills to improve care, and patient and healthcare worker protection (both physically and psychologically) needs to be a given. Any development of systems will best be co-produced with the people who receive and deliver care in an equal partnership. Finally, the new systems need to be conscious of emerging threats (such as the challenge of climate change), building sustainable health systems that also address the structural inequities that currently exist.

Measuring Health Outcomes in HIV: Time to Bring in the Patient Experience.

Introduction: Over the past decade, the global response to HIV has led to a reduction in the number of new infections, and a decrease in associated mortality. Yet, the number of people living with HIV (PLHIV) is high, with an estimated 38 million infected worldwide. As HIV shifts from being an acute terminal illness to a chronic condition, evaluating programmatic responses to HIV with sole reliance on biological markers (such as viral load or CD4 cell count) as proxies for patient health may no longer be suitable. HIV affects the lives of those infected in myriad ways which should be reflected in programme evaluations by measuring health-related quality of life, in addition to biomarkers. Discussion: In this commentary we argue that there is a pressing need to review how a "good" health outcome is defined and measured in light of care systems moving towards value-based frameworks that measure value in terms of the actual health outcomes achieved (rather than processes of care), global response shifting to providing long-term care for PLHIV in the community, and integrating HIV as part of universal health coverage plans. Efforts should be directed towards validating generic and disease specific patient-reported measures of PLHIV, to identify the most suitable tools. Such efforts will ensure that patient experience is appropriately captured, especially to be used in programme or economic evaluations. Conclusions: It is only by recognising and measuring the full range of health, mental and social outcomes related to the disease that the health status of PLHIV can be fully understood.

Use and impact of virtual primary care on quality and safety: The public's perspectives during the COVID-19 pandemic.

INTRODUCTION: With the onset of Coronavirus disease (COVID-19), primary care has swiftly transitioned from face-to-face to virtual care, yet it remains largely unknown how this has impacted the quality and safety of care. We aim to evaluate patient use of virtual primary care models during COVID-19, including change in uptake, perceived impact on the quality and safety of care and willingness of future use. METHODOLOGY: An online cross-sectional survey was administered to the public across the United Kingdom, Sweden, Italy and Germany. McNemar tests were conducted to test pre- and post-pandemic differences in uptake for each technology. One-way analysis of variance was conducted to examine patient experience ratings and perceived impacts on healthcare quality and safety across demographic characteristics. RESULTS: Respondents (n = 6326) reported an increased use of telephone consultations ( + 6.3%, p < .001), patient-initiated services ( + 1.5%, n = 98, p < 0.001), video consultations ( + 1.4%, p < .001), remote triage ( + 1.3, p < 0.001) and secure messaging systems ( + 0.9%, p = .019). Experience rates using virtual care technologies were higher for men (2.4 ± 1.0 vs. 2.3 ± 0.9, p < .001), those with higher literacy (2.8 ± 1.0 vs. 2.3 ± 0.9, p < .001), and participants from Germany (2.5 ± 0.9, p < .001). Healthcare timeliness and efficiency were the dimensions most often reported as being positively impacted by virtual technologies (60.2%, n = 2793 and 55.7%, n = 2,401, respectively), followed by effectiveness (46.5%, n = 1802), safety (45.5%, n = 1822), patient-centredness (45.2%, n = 45.2) and equity (42.9%, n = 1726). Interest in future use was highest for telephone consultations (55.9%), patient-initiated digital services (56.1%), secure messaging systems (43.4%), online triage (35.1%), video consultations (37.0%) and chat consultations (30.1%), although significant variation was observed between countries and patient characteristics. DISCUSSION: Future work must examine the drivers and determinants of positive experiences using remote care to co-create a supportive environment that ensures equitable adoption and use. Comparative analysis between countries and health systems offers the opportunity for policymakers to learn from best practices internationally.

How to improve patient safety in fragile, conflict-affected and vulnerable settings: a Delphi study protocol.

INTRODUCTION: There is a high burden of adverse events and poor outcomes in fragile, conflict-affected and vulnerable (FCV) settings. To improve outcomes, there is a need to better identify which interventions can improve patient safety in these settings, as well as to develop strategies to optimise their implementation. OBJECTIVE: This study intends to generate a consensus on the most relevant patient safety interventions from experts with experience on FCV settings, including frontline clinicians and managers/administrators, non-governmental organisations, policymakers and researchers. METHODS AND ANALYSIS: The study uses an online Delphi research approach (eDelphi). Participants will include experts from a range of backgrounds, including those working in a variety of FCV settings. Participants will be established contacts known to the research team or recruited via snowball sampling, and will be asked to identify and rank the importance of a variety of patient safety interventions. Consensus will be defined as >70% of participants agreeing/strongly agreeing or disagreeing/strongly disagreeing with a statement. Data analysis will be completed in Microsoft Excel and NVivo. The primary outcome of the study will be a list of the most relevant and applicable patient safety interventions for FCV settings. ETHICS AND DISSEMINATION: The study has received approval from Imperial College London Ethics Committee (reference number 20IC665). Anonymous results will be made available to the public, academic organisations and policymakers.

How can we make better health decisions a Best Buy for all?: Commentary based on discussions at iDSI roundtable on 2 nd May 2019 London, UK.

The World Health Organization (WHO) resolution calling on Member States to work towards achieving universal health coverage (UHC) has increased the need for prioritizing health spending. Such need will soon accelerate as low- and middle-income countries transition from external aid. Countries will have to make difficult decisions on how best to integrate and finance previously donor-funded technologies and health services into their UHC packages in ways that are equitable, and operationally and financially sustainable. The International Decision Support Initiative (iDSI) is a global network of health, policy and economic expertise which supports countries in making better decisions about how best and how much to spend public money on healthcare. iDSI core partners include Center For Global Development, China National Health Development Research Center, Clinton Health Access Initiative, Health Intervention and Technology Assessment Program, Thailand / National Health Foundation, Imperial College London, Kenya Medical Research Institute, and the Norwegian Institute of Public Health. In May 2019, iDSI convened a roundtable entitled Why strengthening health systems to make better decisions is a Best Buy. The event brought together members of iDSI, development partners and other organizations working in the areas of evidence-informed priority-setting, resource allocation and purchasing. The roundtable participants identified key challenges and activities that could be undertaken by the broader health technology assessment (HTA) community to further country-led capacity building, as well to foster deeper collaboration between the community itself. HTA is a tool which can assist governments and development partners with evaluating alternative investment options in a defensible and accountable fashion. The definition and scope of HTA, and what it can achieve and support, can be presented more clearly and cohesively to stakeholders. Organizations engaging in HTA must develop deeper collaboration, and integrate existing collaborations, to ensure progress in developing HTA institutionalization globally is well organized and sustainable.