Impact of fatigue as the primary determinant of functional limitations among patients with post-COVID-19 syndrome: a cross-sectional observational study.

OBJECTIVES: To describe self-reported characteristics and symptoms of treatment-seeking patients with post-COVID-19 syndrome (PCS). To assess the impact of symptoms on health-related quality of life (HRQoL) and patients' ability to work and undertake activities of daily living. DESIGN: Cross-sectional single-arm service evaluation of real-time user data. SETTING: 31 post-COVID-19 clinics in the UK. PARTICIPANTS: 3754 adults diagnosed with PCS in primary or secondary care deemed suitable for rehabilitation. INTERVENTION: Patients using the Living With Covid Recovery digital health intervention registered between 30 November 2020 and 23 March 2022. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the baseline Work and Social Adjustment Scale (WSAS). WSAS measures the functional limitations of the patient; scores of ≥20 indicate moderately severe limitations. Other symptoms explored included fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue), depression (Patient Health Questionnaire-Eight Item Depression Scale), anxiety (Generalised Anxiety Disorder Scale, Seven-Item), breathlessness (Medical Research Council Dyspnoea Scale and Dyspnoea-12), cognitive impairment (Perceived Deficits Questionnaire, Five-Item Version) and HRQoL (EQ-5D). Symptoms and demographic characteristics associated with more severe functional limitations were identified using logistic regression analysis. RESULTS: 3541 (94%) patients were of working age (18-65); mean age (SD) 48 (12) years; 1282 (71%) were female and 89% were white. 51% reported losing ≥1 days from work in the previous 4 weeks; 20% reported being unable to work at all. Mean WSAS score at baseline was 21 (SD 10) with 53% scoring ≥20. Factors associated with WSAS scores of ≥20 were high levels of fatigue, depression and cognitive impairment. Fatigue was found to be the main symptom contributing to a high WSAS score. CONCLUSION: A high proportion of this PCS treatment-seeking population was of working age with over half reporting moderately severe or worse functional limitation. There were substantial impacts on ability to work and activities of daily living in people with PCS. Clinical care and rehabilitation should address the management of fatigue as the dominant symptom explaining variation in functionality.

Effectiveness of digital and remote provision of the Healthier You: NHS Diabetes Prevention Programme during the COVID-19 pandemic.

AIMS: To assess weight change in the Healthier You: NHS Diabetes Prevention Programme (NHS DPP) delivered via video conferencing (remote) sessions or delivered via specific digital interventions through apps or websites, during the COVID-19 pandemic compared to group-based face-to-face interventions, pre-pandemic. METHODS: Prospectively collected national service-level data relating to individuals with non-diabetic hyperglycaemia (HbA1c 42-47 mmol/mol (6.0%-6.4%) or fasting plasma glucose 5.5-6.9 mmol/L) referred to the NHS DPP from June 2016 to March 2022. RESULTS: Between March 2020 and March 2022, 335,961 people were referred to the programme and were offered a choice of remote or digital intervention. This was preceded by 556,793 people referred to the face-to-face programme between June 2016 and February 2022. Uptakes to intervention sessions were 47% for those offered a choice and 39% for face-to-face. Remote and digital participants were significantly younger (60 and 56 vs. 65 years) and heavier (86.1 kg and 91.0 kg vs. 84.1 kg) compared to face-to-face. Weight change was assessed for 42,407 remote, 7699 digital and 97,205 face-to-face participants with sufficient time to have finished the programme and no missing data. Mean weight losses for participants attending at least one intervention session were: 2.40 (2.36-2.44) kg, 2.59 (2.49-2.68) kg and 2.01 (1.98-2.04) kg for remote, digital and face-to-face participants respectively. Corresponding mean weight losses for those who completed the programme were: 3.24 (3.19-3.30) kg, 4.76 (4.60-4.92) kg and 3.04 (3.00-3.07) kg. There were no significant differences in weight change between interventions by ethnicity and deprivation. CONCLUSIONS: Weight losses achieved through remote and digital interventions were greater than those previously achieved through face-to-face interventions, without evidence of exacerbation of health inequalities.

Assessing the impact of online postal self-sampling for sexually transmitted infections on health inequalities, access to care and clinical outcomes in the UK: protocol for ASSIST, a realist evaluation.

INTRODUCTION: The past decade has seen a rapid increase in the volume and proportion of testing for sexually transmitted infections that are accessed via online postal self-sampling services in the UK. ASSIST (Assessing the impact of online postal self-sampling for sexually transmitted infections on health inequalities, access to care and clinical outcomes in the UK) aims to assess the impact of these services on health inequalities, access to care, and clinical and economic outcomes, and to identify the factors that influence the implementation and sustainability of these services. METHODS AND ANALYSIS: ASSIST is a mixed-methods, realist evaluated, national study with an in-depth focus of three case study areas (Birmingham, London and Sheffield). An impact evaluation, economic evaluation and implementation evaluation will be conducted. Findings from these evaluations will be analysed together to develop programme theories that explain the outcomes. Data collection includes quantitative data (using national, clinic based and online datasets); qualitative interviews with service users, healthcare professionals and key stakeholders; contextual observations and documentary analysis. STATA 17 and NVivo will be used to conduct the quantitative and qualitative analysis, respectively. ETHICS AND DISSEMINATION: This study has been approved by South Central - Berkshire Research Ethics Committee (ref: 21/SC/0223). All quantitative data accessed and collected will be anonymous. Participants involved with qualitative interviews will be asked for informed consent, and data collected will be anonymised.Our dissemination strategy has been developed to access and engage key audiences in a timely manner and findings will be disseminated via the study website, social media, in peer-reviewed scientific journals, at research conferences, local meetings and seminars and at a concluding dissemination and networking event for stakeholders.

Frameworks for Implementation, Uptake, and Use of Cardiometabolic Disease-Related Digital Health Interventions in Ethnic Minority Populations: Scoping Review.

BACKGROUND: Digital health interventions have become increasingly common across health care, both before and during the COVID-19 pandemic. Health inequalities, particularly with respect to ethnicity, may not be considered in frameworks that address the implementation of digital health interventions. We considered frameworks to include any models, theories, or taxonomies that describe or predict implementation, uptake, and use of digital health interventions. OBJECTIVE: We aimed to assess how health inequalities are addressed in frameworks relevant to the implementation, uptake, and use of digital health interventions; health and ethnic inequalities; and interventions for cardiometabolic disease. METHODS: SCOPUS, PubMed, EMBASE, Google Scholar, and gray literature were searched to identify papers on frameworks relevant to the implementation, uptake, and use of digital health interventions; ethnically or culturally diverse populations and health inequalities; and interventions for cardiometabolic disease. We assessed the extent to which frameworks address health inequalities, specifically ethnic inequalities; explored how they were addressed; and developed recommendations for good practice. RESULTS: Of 58 relevant papers, 22 (38%) included frameworks that referred to health inequalities. Inequalities were conceptualized as society-level, system-level, intervention-level, and individual. Only 5 frameworks considered all levels. Three frameworks considered how digital health interventions might interact with or exacerbate existing health inequalities, and 3 considered the process of health technology implementation, uptake, and use and suggested opportunities to improve equity in digital health. When ethnicity was considered, it was often within the broader concepts of social determinants of health. Only 3 frameworks explicitly addressed ethnicity: one focused on culturally tailoring digital health interventions, and 2 were applied to management of cardiometabolic disease. CONCLUSIONS: Existing frameworks evaluate implementation, uptake, and use of digital health interventions, but to consider factors related to ethnicity, it is necessary to look across frameworks. We have developed a visual guide of the key constructs across the 4 potential levels of action for digital health inequalities, which can be used to support future research and inform digital health policies.

Digital Health Intervention Design and Deployment for Engaging Demographic Groups Likely to Be Affected by the Digital Divide: Protocol for a Systematic Scoping Review.

BACKGROUND: Digital health interventions refer to interventions designed to support health-related knowledge transfer and are delivered via digital technologies, such as mobile apps. Digital health interventions are a double-edged sword: they have the potential to reduce health inequalities, for example, by making treatments available remotely to rural populations underserved by health care facilities or by helping to overcome language barriers via in-app translation services; however, if not designed and deployed with care, digital health interventions also have the potential to increase health inequalities and exacerbate the effects of the digital divide. OBJECTIVE: The aim of this study is to review ways to mitigate the digital divide through digital health intervention design, deployment, and engagement mechanisms sensitive to the needs of digitally excluded populations. METHODS: This protocol outlines the procedure for a systematic scoping review that follows the methodology recommended by the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidance. The following databases will be searched for primary research studies published in English from October 1, 2011, to October 1, 2021: Cochrane Library, Epistemonikos, NICE Evidence, PROSPERO, PubMed (with MEDLINE and Europe PMC), and Trip. In addition, the following sources of gray literature will be searched: Conference Proceedings Citation Index, Health Management Information Consortium, International HTA Database, OpenGrey, The Grey Literature Report, Google Scholar Basic Search UK, MedNar Deep Web Search Engine, and Carrot2. We will select publications that meet the following inclusion criteria: primary research papers that evaluated digital health interventions that describe features of digital health intervention design and deployment that enable or hinder access to and engagement with digital health interventions by adults from demographic groups likely to be affected by the digital divide (eg, older age, minority ethnic groups, lower income, and lower education level). A random selection of 25 publications identified from the search will be double screened by four reviewers. If there is >75% agreement for included/excluded publications, the team will continue to screen all the identified publications. For all included publications, study characteristics will be extracted by one author and checked for agreement by a second author, with any disagreements resolved by consensus among the study team. Consultation digital health intervention design and deployment, and digital health intervention users will also be conducted in parallel. RESULTS: The review is underway and is anticipated to be completed by September 2022. CONCLUSIONS: The results will have implications for researchers and policy makers using digital health interventions for health improvement peripandemic and post pandemic, and will inform best practices in the design and delivery of digital health interventions. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/32538.

Development, deployment and evaluation of digitally enabled, remote, supported rehabilitation for people with long COVID-19 (Living With COVID-19 Recovery): protocol for a mixed-methods study.

INTRODUCTION: Long COVID-19 is a distressing, disabling and heterogeneous syndrome often causing severe functional impairment. Predominant symptoms include fatigue, cognitive impairment ('brain fog'), breathlessness and anxiety or depression. These symptoms are amenable to rehabilitation delivered by skilled healthcare professionals, but COVID-19 has put severe strain on healthcare systems. This study aims to explore whether digitally enabled, remotely supported rehabilitation for people with long COVID-19 can enable healthcare systems to provide high quality care to large numbers of patients within the available resources. Specific objectives are to (1) develop and refine a digital health intervention (DHI) that supports patient assessment, monitoring and remote rehabilitation; (2) develop implementation models that support sustainable deployment at scale; (3) evaluate the impact of the DHI on recovery trajectories and (4) identify and mitigate health inequalities due to the digital divide. METHODS AND ANALYSIS: Mixed-methods, theoretically informed, single-arm prospective study, combining methods drawn from engineering/computer science with those from biomedicine. There are four work packages (WP), one for each objective. WP1 focuses on identifying user requirements and iteratively developing the intervention to meet them; WP2 combines qualitative data from users with learning from implementation science and normalisation process theory, to promote adoption, scale-up, spread and sustainability of the intervention; WP3 uses quantitative demographic, clinical and resource use data collected by the DHI to determine illness trajectories and how these are affected by use of the DHI; while WP4 focuses on identifying and mitigating health inequalities and overarches the other three WPs. ETHICS AND DISSEMINATION: Ethical approval obtained from East Midlands - Derby Research Ethics Committee (reference 288199). Our dissemination strategy targets three audiences: (1) Policy makers, Health service managers and clinicians responsible for delivering long COVID-19 services; (2) patients and the public; (3) academics. TRIAL REGISTRATION NUMBER: Research Registry number: researchregistry6173.

Economic Evaluation of Digital Health Interventions: Methodological Issues and Recommendations for Practice.

Health care interventions are increasingly being delivered through digital technologies, offering major opportunities for delivering more health gains from scarce health care resources. Digital health interventions (DHIs) raise distinct challenges for economic evaluations compared with drugs and medical devices, not least due to their interacting, evolving features. The implications of the distinctive nature of DHIs for the methodological choices underpinning their economic evaluation is not well understood. This paper provides an in-depth discussion of distinct features of DHIs and how they might impact the design, measurement, analysis and reporting of cost-effectiveness analysis conducted alongside both randomised and non-randomised studies. These include aspects related to choice of comparator, costs and benefits assessment, study perspective and type of economic analysis. We argue that typical methodological standpoints, such as taking a health service perspective, focusing on health-related benefits and adopting cost-utility analyses, as typically adopted in the economic evaluation of non-digital technologies (pharmaceutical drugs and medical devices), are unlikely to be appropriate for DHIs. We illustrate how these methodological aspects can be appropriately addressed in an evaluation of a digitally supported, remote rehabilitation programme for patients with Long Covid in England. We highlight several methodological considerations for improving practice and areas where further methodological work is required.

Whistleblower Cases in Health Law: A Primer for Legal Nurse Consultants

Federal and state law establishes strong protections for whistleblowers in unsafe positions and fearing retaliation. In this framework, the COVID-19 ushered new and widespread issues for potential claimants working in the healthcare feld and public-facing employment positions. Legal nurse consultants provide integral litigation support in the investigation and prosecution or defense of these claims.