CLINICAL QUESTION: What is the role of drugs in the treatment of patients with covid-19?
CONTEXT: The evidence base for therapeutics for covid-19 is evolving with numerous randomised controlled trials (RCTs) recently completed and underway. Emerging SARS-CoV-2 variants and subvariants are changing the role of therapeutics.
WHAT IS NEW?: The guideline development group (GDG) defined 1.5% as a new threshold for an important reduction in risk of hospitalisation in patients with non-severe covid-19. Combined with updated baseline risk estimates, this resulted in stratification into patients at low, moderate, and high risk for hospitalisation. New recommendations were added for moderate risk of hospitalisation for nirmatrelvir/ritonavir, and for moderate and low risk of hospitalisation for molnupiravir and remdesivir. New pharmacokinetic evidence was included for nirmatrelvir/ritonavir and molnupiravir, supporting existing recommendations for patients at high risk of hospitalisation. The recommendation for ivermectin in patients with non-severe illness was updated in light of additional trial evidence which reduced the high degree of uncertainty informing previous guidance. A new recommendation was made against the antiviral agent VV116 for patients with non-severe and with severe or critical illness outside of randomised clinical trials based on one RCT comparing the drug with nirmatrelvir/ritonavir. The structure of the guideline publication has also been changed; recommendations are now ordered by severity of covid-19.
ABOUT THIS GUIDELINE: This living guideline from the World Health Organization (WHO) incorporates new evidence to dynamically update recommendations for covid-19 therapeutics. The GDG typically evaluates a therapy when the WHO judges sufficient evidence is available to make a recommendation. While the GDG takes an individual patient perspective in making recommendations, it also considers resource implications, acceptability, feasibility, equity, and human rights. This guideline was developed according to standards and methods for trustworthy guidelines, making use of an innovative process to achieve efficiency in dynamic updating of recommendations. The methods are aligned with the WHO Handbook for Guideline Development and according to a pre-approved protocol (planning proposal) by the Guideline Review Committee (GRC). A box at the end of the article outlines key methodological aspects of the guideline process. MAGIC Evidence Ecosystem Foundation provides methodological support, including the coordination of living systematic reviews with network meta-analyses to inform the recommendations. The full version of the guideline is available online in MAGICapp and in PDF on the WHO website, with a summary version here in The BMJ. These formats should facilitate adaptation, which is strongly encouraged by WHO to contextualise recommendations in a healthcare system to maximise impact.
FUTURE RECOMMENDATIONS: Recommendations on anticoagulation are planned for the next update to this guideline. Updated data regarding systemic corticosteroids, azithromycin, favipiravir and umefenovir for non-severe illness, and convalescent plasma and statin therapy for severe or critical illness, are planned for review in upcoming guideline iterations.
METHODS: A retrospective analysis was conducted using national administrative data from 1124 public primary care clinics. Eight indicators were selected to measure service utilisation covering antenatal, postnatal, women's health, child health, and immunisation services. Interrupted time-series analysis was used to evaluate changes in levels and trends of indicators during four different periods: pre-pandemic (January 2019-February 2020), during pandemic and first lockdown (March-May 2020), after the first lockdown was lifted (June-December 2020) and after the second lockdown was implemented (January-June 2021).
RESULTS: Most indicators showed no significant trend in monthly utilisation prior to the pandemic. The onset of the pandemic and first lockdown implementation were associated with significant decreasing trends in child health (-19.23%), women's health (-10.12%), antenatal care (-8.10%), contraception (-6.50%), postnatal care (-4.85%) and postnatal care 1-week (-3.52%) indicators. These indicators showed varying degrees of recovery after the first lockdown was lifted. The implementation of the second lockdown caused transient reduction ranging from -11.29% to -25.92% in women's health, contraception, child and two postnatal indicators, but no sustained reducing trend was seen afterwards. Two immunisation indicators appeared unaffected throughout the study period.
CONCLUSION: The COVID-19 pandemic significantly impacted MCH services utilisation in Malaysia. While most MCH services were negatively affected by the lockdown implementation with varying degrees of recovery, infant immunisation showed resilience throughout. This highlights the need for a targeted preparedness plan to ensure the resilience of MCH services in future crises.
METHODOLOGY: A rapid evidence review was conducted to identify how community engagement is used for infectious disease prevention and control during epidemics. Three databases were searched in addition to extensive snowballing for grey literature. Previous epidemics were limited to Ebola, Zika, SARS, Middle East respiratory syndromeand H1N1 since 2000. No restrictions were applied to study design or language.
RESULTS: From 1112 references identified, 32 articles met our inclusion criteria, which detail 37 initiatives. Six main community engagement actors were identified: local leaders, community and faith-based organisations, community groups, health facility committees, individuals and key stakeholders. These worked on different functions: designing and planning, community entry and trust building, social and behaviour change communication, risk communication, surveillance and tracing, and logistics and administration.
CONCLUSION: COVID-19's global presence and social transmission pathways require social and community responses. This may be particularly important to reach marginalised populations and to support equity-informed responses. Aligning previous community engagement experience with current COVID-19 community-based strategy recommendations highlights how communities can play important and active roles in prevention and control. Countries worldwide are encouraged to assess existing community engagement structures and use community engagement approaches to support contextually specific, acceptable and appropriate COVID-19 prevention and control measures.
METHODS AND ANALYSIS: We will systematically conduct a comprehensive literature search using various databases including PubMed, EMBASE, Scopus, CENTRAL and Google Scholar to identify potential studies. The search will be performed for any eligible articles from the earliest published articles up to latest available studies in 2020. We will include all the observational studies such as cohort case-control and cross-sectional studies that explains or measures the effects of temperature and/or humidity and/or air quality and/or anthropic activities that is associated with SARS-CoV-2. Study selection and reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and Meta-Analysis of Observational Studies in Epidemiology guideline. All data will be extracted using a standardised data extraction form and quality of the studies will be assessed using the Newcastle-Ottawa Scale guideline. Descriptive and meta-analysis will be performed using a random effect model in Review Manager File.
ETHICS AND DISSEMINATION: No primary data will be collected, and thus no formal ethical approval is required. The results will be disseminated through a peer-reviewed publication and conference presentation.
PROSPERO REGISTRATION NUMBER: CRD42020176756.
DESIGN: A cross-sectional study performed using an anonymous online questionnaire distributed through social media, email and the Department of Social Welfare.
SETTING: Malaysian families were invited to answer the questionnaires. The sampling was performed between 12 May 2020 and 9 June 2020.
INTERVENTION: The psychological impact was assessed using the Impact of Event Scale-Revised (IES-R) and Children's Revised Impact of Event Scale (CRIES). The mental health status was assessed using the Depression, Anxiety and Stress Scale (DASS) 21.
MAIN OUTCOME MEASURE: (1) Psychological impact on Malaysian families. (2) Prevalence of mental health status of Malaysian families during COVID-19 pandemic.
RESULT: A total of 409 Malaysian families have responded (409 parents and 348 children), 154 respondents (38%) reported high psychological impact (score 14) for psychological construct and 189 respondents (46%) reported high psychological impact (score 6) for behavioural construct. A significantly higher proportion of respondents with not permanent employment status of the family lead reported high psychological impact. The prevalence of anxiety reported from family respondents was 23%. Forty-five children answered the DASS-21 questionnaire; 28.5% reported anxiety, 31.4% reported depression and 13.3% reported stress. The job security status of the family lead was found to be the predictive factor for the mean total IES-R score (psychological construct) and ethnicity for mean total CRIES-8 and CRIES-13.
CONCLUSION: Rates of depression and anxiety during the COVID-19 pandemic were high. Findings suggest that urgent measures to ensure job security among Malaysian families are important to reduce the impact of the COVID-19 pandemic on psychosocial and mental health outcomes.
DESIGN: A cross-sectional facility-based survey.
SETTING: Hospitals around the country with different levels of care.
PARTICIPANTS: A total of 1795 respondents, including 360 men and 1435 women who participated in the survey.
PRIMARY OUTCOME MEASURES: Burnout was assessed using the Physician Work Life Study. A score of ≥3 implied burnout.
RESULTS: Of the 1795 respondents, 723 (40.3%) reported burnout, and 669 (37.3%) cared for patients with COVID-19. Anxiety levels were mild in 185 (10.3%) respondents, moderate in 209 (11.6%) and severe in 1401 (78.1%). The mean Center for Epidemiologic Studies Depression Scale-10 score was 9.5±6.3, and 817 (45.5%) respondents were classified as having depression. Factors associated with burnout were working in acute and critical care (ACC) divisions (adjusted OR (aOR)=1.84, 95% CI 1.20 to 3.39, p=0.019), caring for patients with COVID-19 (aOR=3.90, 95% CI 1.14 to 13.37, p=0.031) and having depressive disorder (aOR=9.44, 95% CI 7.44 to 11.97, p<0.001).
CONCLUSIONS: Physicians and nurses are vulnerable to burnout during a pandemic, especially those working in ACC divisions. Anxiety disorder, depressive disorder and care of patients with COVID-19 may be factors that influence the occurrence of burnout among healthcare providers.
SETTING AND PARTICIPANTS: Collaborators from the International Society of Nephrology (ISN), Dialysis Outcomes and Practice Patterns Study and ISN-Global Kidney Health Atlas developed an online survey that was administered electronically to key nephrology leaders in 174 countries between 2 July and 4 August 2021.
RESULTS: Survey responses were received from 99 of 174 countries from all 10 ISN regions, among which 88/174 (50%) were complete. At least one vaccine was available in 96/99 (97%) countries. In 71% of the countries surveyed, patients on dialysis were prioritised for vaccination, followed by patients living with a kidney transplant (KT) (62%) and stage 4/5 CKD (51%). Healthcare workers were the most common high priority group for vaccination. At least 50% of patients receiving in-centre haemodialysis, peritoneal dialysis or KT were estimated to have completed vaccination at the time of the survey in 55%, 64% and 51% of countries, respectively. At least 50% of patients in all three patient groups had been vaccinated in >70% of high-income countries and in 100% of respondent countries in Western Europe.The most common barriers to vaccination of patients were vaccine hesitancy (74%), vaccine shortages (61%) and mass vaccine distribution challenges (48%). These were reported more in low-income and lower middle-income countries compared with high-income countries.
CONCLUSION: Patients with advanced CKD or KFRT were prioritised in COVID-19 vaccination in most countries. Multiple barriers led to substantial variability in the successful achievement of COVID-19 vaccination across the world, with high-income countries achieving the most access and success.
METHODS AND ANALYSIS: The implementation research logic model guided the development of the study and implementation outcome measures were informed by the 'Reach, Effectiveness, Adoption, Implementation and Maintenance' (RE-AIM) framework. This CRC screening intervention for Malaysia uses home-testing and digital, small media, communication to improve CRC screening uptake. A sample of 780 people aged 50-75 years living in Segamat district, Malaysia, will be selected randomly from the South East Asia Community Observatory (SEACO) database. Participants will receive a screening pack as well as a WhatsApp video of a local doctor to undertake a stool test safely and to send a photo of the test result to a confidential mobile number. SEACO staff will inform participants of their result. Quantitative data about follow-up clinic attendance, subsequent hospital tests and outcomes will be collected. Logistic regression will be used to investigate variables that influence screening completion and we will conduct a budget impact-analysis of the intervention and its implementation. Qualitative data about intervention implementation from the perspective of participants and stakeholders will be analysed thematically.
ETHICS AND DISSEMINATION: Ethics approval has been granted by Monash University Human Research Ethics Committee (MUHREC ID: 29107) and the Medical Review and Ethics Committee (Reference: 21-02045-O7G(2)). Results will be disseminated through publications, conferences and community engagement activities.
TRIAL REGISTRATION NUMBER: National Medical Research Register Malaysia: 21-02045-O7G(2).
DESIGN: Scoping review, following the Arksey and O'Malley's framework, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
DATA SOURCES: PubMed, Web of Science and Scopus were searched from 1 January 2020 through 31 December 2021.
ELIGIBILITY CRITERIA: Original articles, reviews, case studies and reports written in English were included. Works without full article and articles that did not answer the research questions were excluded.
DATA EXTRACTION AND SYNTHESIS: Data were extracted using a standardised data extraction form in Microsoft Excel. The findings of all included articles were synthesised narratively.
RESULTS: Eighty-five records were reviewed and 25 studies were included. For the field hospital implementation strategies, 'surge capacity', namely space, human resource, supply and system, was discussed in addition to the preparation and workflow of other services such as pharmacy, rehabilitation, food and nutrition. The management of COVID-19 field hospitals is challenging with respect to staff and resource shortages, inability to anticipate patient load and poor communication. The opportunities and recommendations for improvement of management were also highlighted.
CONCLUSIONS: The compilation of lessons learnt may help improve the future management of field hospitals, administratively and clinically.
METHODS AND ANALYSIS: This cross-sectional study uses an online survey to administer a novel COVID Psychosocial Impacts Scale (CPIS) alongside established measures of psychological distress, post-traumatic stress, well-being and post-traumatic growth in the appropriate language. Participants will include adults aged 18 years and above, recruited from Indonesia, Iraq, Iran, Malaysia, Pakistan, Somalia and Turkey, with a pragmatic target sample size of 500 in each country.Data will be analysed descriptively on sociodemographic and study variables. In addition, CPIS will be analysed psychometrically (for reliability and validity) to assess the suitability of use in a given context. Finally, within-subjects and between-subjects analyses will be carried out using multi-level mixed-effect models to examine associations between key sociodemographic and study variables.
ETHICS AND DISSEMINATION: Ethical approval was granted by the Human Ethics Committee, University of Otago, New Zealand (Ref. No. 21/102). In addition, international collaborators obtained local authorisation or ethical approval in their respective host universities before data collection commenced.Participants will give informed consent before taking part. Data will be collected and stored securely on the University of Otago, New Zealand Qualtrics platform using an auto-generated non-identifiable letter-number string. Data will be available on reasonable request. Findings will be disseminated by publications in scientific journals and/or conference presentations.
TRIAL REGISTRATION NUMBER: NCT05052333.
METHODS AND ANALYSIS: A living systematic review will be conducted which includes an initial systematic review and bimonthly review updates. Searching and screening for the review and subsequent updates will be done in four streams: a systematic search of six databases, grey literature review, preprint review and citizen sourcing. The screening will be done by a minimum of two reviewers at title/abstract and full-text in Covidence, a systematic review management software. Data will be extracted across predefined fields in an excel spreadsheet that includes information about article characteristics, context and population, community engagement approaches, and outcomes. Synthesis will occur using the convergent integrated approach. We will explore the potential to quantitatively synthesise primary outcomes depending on heterogeneity of the studies.
ETHICS AND DISSEMINATION: The initial review and subsequent bimonthly searches and their results will be disseminated transparently via open-access methods. Quarterly briefs will be shared on the reviews' social media platforms and across other interested networks and repositories. A dedicated web link will be created on the Community Health-Community of Practice site for sharing findings and obtaining feedback. A mailing list will be developed and interested parties can subscribe for updates.
PROSPERO REGISTRATION NUMBER: CRD42022301996.
METHODS AND ANALYSIS: We will conduct a systematic search in PubMed, Scopus, Web of Science and grey literature. Descriptive statistics will be used to report the characteristics of included studies. The facilitators and barriers to DHTs implementation, gathered from both quantitative and qualitative data, will be synthesised using a parallel-results convergent synthesis design. A thematic analysis, employing an inductive approach, will be conducted to categorise these facilitators and barriers into coherent themes. Additionally, we will identify and categorise all available DHTs based on their equipment types and methods of operation to develop an innovative classification framework.
ETHICS AND DISSEMINATION: Formal ethical approval is not required, as primary data collection is not involved in this study. The findings will be disseminated through peer-reviewed publications, conference presentations and meetings with key stakeholders and partners in the field of digital health.
DESIGN: We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).
SETTING: We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings-namely, workplace and healthcare facilities.
RESULTS: Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04-3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58-87% for countries with off-site self-testing (outside the workplace, for example, home) and 15-50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29-35%) versus off-site self-testing (7-27%).
CONCLUSIONS: Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.
METHODS AND ANALYSIS: This is an observational study that will use anonymised online surveys to estimate the prevalence of burnout symptoms at two time points: during the COVID-19 pandemic in 2020 and in 2022 (assumed to be after the pandemic). Gastroenterologists from Singapore, Malaysia, Thailand, Indonesia, Philippines and Brunei will be invited to participate in the online survey through their national gastroenterology and endoscopy societies. Burnout will be assessed using the Maslach Burnout Inventory-Human Services Survey tool. Supplementary questions will collect demographic and qualitative data. Associations between demographic characteristics and burnout will be tested by multiple regression.
RESULTS: The prevalence of burnout symptoms in gastroenterology during the COVID-19 pandemic, and the baseline prevalence after COVID-19, will be established in the above-mentioned countries. Work-related stressors commonly associated with burnout will be identified, allowing the introduction of preventative measures to reduce burnout in the future.
ETHICS AND DISSEMINATION: Ethical approval was granted by the Singhealth Centralised Institutional Review Board (2020/2709). Results will be submitted for publication.
METHODS: Based on the best available clinical knowledge and best practices, an eight member multidisciplinary group of clinical and quality experts undertook the development of a clinical algorithm-based toolkit to guide training and practice for the management of patients with COVID-19. The team followed Horabin and Lewis' seven-step approach in developing the algorithms and a five-step method in writing them. Moreover, we applied Rosenfeld et al's five points to each algorithm.
RESULTS: A set of seven clinical algorithms and one illustrative layout diagram were developed. The algorithms were augmented with documentation forms, data-collection online forms and spreadsheets and an indicators' reference sheet to guide implementation and performance measurement. The final version underwent several revisions and amendments prior to approval.
CONCLUSIONS: A large volume of published literature on the topic of COVID-19 pandemic was translated into a user-friendly, algorithm-based toolkit for the management of patients with COVID-19. This toolkit can be used for training and decision-making to improve the quality of care provided to patients with COVID-19.