Monkeypox Knowledge and Vaccine Hesitancy of Czech Healthcare Workers: A Health Belief Model (HBM)-Based Study.

BACKGROUND: The recent human monkeypox virus (HMPXV) outbreak in non-endemic countries that started in May 2022 has raised concerns among public health authorities worldwide. Healthcare workers (HCWs) play a decisive role during epidemics in transmitting accurate information to the public and motivating them to pursue protective behaviours, including immunisation. METHODS: A cross-sectional survey-based study was conducted in the Czech Republic in September 2022 to evaluate HMPXV-related knowledge and vaccination perceptions among HCWs. The study utilised a digital self-administered questionnaire (SAQ) to collect data from the target population. The proposed SAQ inquired about participants' sociodemographic and anamnestic characteristics, perceived knowledge of HMPXV, factual knowledge, and vaccination perceptions according to the health belief model (HBM). RESULTS: A total of 341 participants were included in this study; most of them were females (88.9%), allied HCWs (89.4%), heterosexuals (87.1%), married (61.9%), and vaccinated against COVID-19 (91.2%). Only 8.8% of the participants agreed to receive vaccination against HMPXV; 44.9% rejected it, while 46.3% were hesitant. While digital news portals (47.5%) and social media (25.8%) were among the most utilised sources of information about HMPXV, the scientific journals (5.6%), ECDC (5%), and the U.S. CDC (1.5%) were the least common sources. The participants demonstrated suboptimal levels of factual knowledge, especially regarding HMPXV vaccines (1.5 ± 1.2 (0-4)) and treatments (0.9 ± 0.9 (0-4)). Additionally, several misconceptions were detectable among the participants, regarding topics such as the availability of effective vaccines and antivirals against HMPXV, the risk of vertical transmission, and homosexual stigmatisation. The HBM indicated that the cues to action and perceived susceptibility were the most important constructs to predict HMPXV vaccine acceptance. CONCLUSIONS: the findings of this study call upon public health practitioners and health policymakers in the Czech Republic to act accordingly in order to determine the drivers of vaccine hesitancy among Czech HCWs. Dedicated educational campaigns should aim to counter the HCWs' misconceptions around HMPXV, and future studies should aim to explore the prevalence and drivers of HMPXV vaccine hesitancy among the general population.

Communication, an important link between healthcare providers: a best practice implementation project.

OBJECTIVES: This project aimed to improve communication skills of medical laboratory staff and the quality of health services. INTRODUCTION: Communication is the basis of all interpersonal actions; optimal and efficient communication needs permanent awareness and training in order to learn these skills. The healthcare industry is a constantly changing field, so communication becomes a very important tool that contributes to change. METHODS: This project has been conducted following the JBI framework to improve the communication process in a medical laboratory. A baseline audit involved 30 multidisciplinary healthcare providers (HCP). Using audit criteria provided by JBI, data for clinical audits were collected using a completed audit questionnaire based on direct observation and interview of participants, and checking the records. Once the information had been gathered, the team involved in the project implemented a three sessions workshop focused on communication to solve/improve identified barriers. A follow-up audit was conducted to assess the outcomes of the intervention. RESULTS: The implementation of the project resulted in the evolution of the participants and the cohesion of the healthcare team. The baseline compliance with best practice for audit criteria shows that only a part of those involved in the study benefited from training communication. Lack of time for team briefings and interactions led to different points of view. In the pandemic context, the implementation of the communication improvement strategy was conducted online, with all 30 HCP participating in training sessions. After the follow-up audit, the evolution was demonstrated by the improvement of the HCP compliance compared with the two audit criteria identified with the insufficient compliance in the basic audit. CONCLUSION: Effective communication is a necessity to meet patient needs and to provide high-quality services. The healthcare team received training for communication focused on interpersonal communication.

Side Effects of COVID-19 Inactivated Virus vs. Adenoviral Vector Vaccines: Experience of Algerian Healthcare Workers.

Healthcare workers were prioritized in vaccination campaigns globally because they are exposed to the highest risk of contamination by SARS-CoV-2. This study evaluated the self-reported post-vaccination side effects of inactivated (BBIBP-CorV and CoronaVac) and adenoviral vector-based (AZD1222, Gam-COVID-Vac and Ad26.COV2.S) vaccines among Algerian healthcare workers using a validated questionnaire. The final analysis included 721 healthcare workers, with a predominance of females (59.1%) and younger individuals 20-30 years old (39.4%). Less than half (49.1%) of the respondents reported at least one local side effect, while 53.8% reported at least one systemic side effect. These side effects were more prevalent among viral vector vaccinees than inactivated virus vaccinees. The most common local side effects were injection site pain (39%) and arm pain (25.4%), while fatigue (34.4%), fever (28.4%), headache (24.8%) and myalgia (22.7%) were the most prevalent systemic side effects. The side effects appeared earlier among inactivated virus vaccines recipients and generally lasted for 2 to 3 days for the two vaccinated groups. The risk factors associated with a higher prevalence of side effects included female gender, allergic individuals, individuals with regular medication, those who contracted the COVID-19 disease and those who received two doses for both inactivated and viral-based vaccines groups. Despite the higher prevalence of post-vaccination side effects among adenoviral vector vaccines recipients, both vaccines groups were equally effective in preventing symptomatic infections, and no life-threatening side effects were reported in either vaccine group.

How the COVID-19 pandemic influences the prevalence of pressure injuries in the Czech Republic: A nationwide analysis of a health registry in 2020.

BACKGROUND: COVID-19 significantly influences the overall patient status and, in severe symptomatology, the ability to move and the low oxygenation of the tissue for the ventilated patient in Intensive Care Units (ICU). There is a higher risk for Pressure injuries (PIs) development. OBJECTIVES: The nationwide analyses of the National health register aimed to compare the prevalence of PIs reported before the pandemic COVID-19 started and during the pandemic in 2020. METHOD: A retrospective, nationwide cross-sectional analysis of data regarding the STROBE checklist collected by the National Health Information System (NHIS), focusing on the PIs reporting based on the International Classification of Diseases (ICD-10) diagnoses L89.0-L89.9 for PIs in 2020. The data from the pandemic period of COVID-19 in 2020 were compared to the prevalence of PI cases in the period 2010-2019 in the Czech Republic in all hospitalized patients. RESULTS: The total number of admissions for L89 in 2020 was 14,441, of which 1509 (10.4%) also had COVID-19. In the ICU were 4386 admissions, 12.1% of which also had COVID-19. A higher proportion of PIs is observed in patients hospitalized with COVID-19 than in patients without COVID-19 (2.62% vs 0.81%, respectively 1.05% vs 0.46% when standardized to the 2013 ESP = European Standard Population). In patients hospitalized in ICU, 3.68% with COVID-19 had PIs vs 1.42% without COVID-19 had PIs (1.97% vs 0.81% using the 2013 ESP). CONCLUSION: The national health registers analyses have proven that the prevalence of PIs was higher among patients hospitalized with the SARS-CoV-2 infection.

An evaluation of the COVID-19 recommendation map identified diverging clinical and public health guidance.

OBJECTIVES: To describe divergence between actionable statements issued by coronavirus disease 2019 (COVID-19) guideline developers cataloged on the "COVID-19 Recommendations and Gateway to Contextualization" platform. STUDY DESIGN AND SETTING: We defined divergence as at least two comparable actionable statements with different explicit judgments of strength, direction, or subgroup consideration of the population or intervention. We applied a content analysis to compare guideline development methods for a sample of diverging statements and to evaluate factors associated with divergence. RESULTS: Of the 138 guidelines evaluated, 85 (62%) contained at least one statement that diverged from another guideline. We identified 223 diverging statements in these 85 guidelines. We grouped statements into 66 clusters. Each cluster addressed the same population, intervention, and comparator group or just similar interventions. Clinical practice statements were more likely to diverge in an explicit judgment of strength or direction compared to public health statements. Statements were more likely to diverge in strength than direction. The date of publication, used evidence, interpretation of evidence, and contextualization considerations were associated with divergence. CONCLUSION: More than half of the assessed guidelines issued at least one diverging statement. This study helps in understanding the types of differences between guidelines issuing comparable statements and factors associated with their divergence.

COVID-19 Vaccine Acceptance of Pregnant and Lactating Women (PLW) in Czechia: An Analytical Cross-Sectional Study.

Pregnant and lactating women (PLW) represent a particular population subset with increased susceptibility for COVID-19 morbidity and mortality, even though the evidence about the safety and efficacy of COVID-19 vaccines was delayed due to their initial exclusion from development trials. This unclear situation could have led to increased COVID-19 vaccine hesitancy levels among PLW; therefore, this study aimed to evaluate the attitudes of Czech PLW towards COVID-19 vaccines and the determinants of their attitudes. An analytical cross-sectional survey-based study was carried out in the University Hospital Brno (South Moravia, Czechia) between August and October 2021. The study utilised a self-administered questionnaire (SAQ) adapted from previous instruments used for the same purpose. The SAQ included closed-ended items covering demographic characteristics, clinical and obstetric characteristics, attitudes towards COVID-19 vaccination, and potential psychosocial predictors of vaccine acceptance. Out of the 362 included participants, 278 were pregnant (PW) and 84 were lactating women (LW). The overall COVID-19 vaccine acceptance (immediate and delayed) level was substantially high (70.2%), with a significant difference between PW (76.6%) and LW (48.8%). Out of the 70.2% who agreed to receive the vaccine, 3.6% indicated immediate acceptance, and 66.6% indicated delayed acceptance. Only 13.3% of the participants indicated their acceptance of their physician's vaccination recommendation during pregnancy or while lactating, and 62.2% were against it. Our results agreed with the recent studies that revealed that PW tended to have a high level of COVID-19 vaccine acceptance, and they were also inclined to resist professional recommendations because they predominantly preferred to delay their vaccination. The pregnancy trimester, education level, employment status, and previous live births were significant determinants for COVID-19 vaccine acceptance. The most commonly preferred vaccine type was mRNA-based vaccines, followed by viral vector-based and inactivated virus vaccines. The first top priority of PLW was vaccine safety for their children, followed by vaccine safety for the PLW and vaccine effectiveness. Regarding psychosocial predictors, media/social media, trust in the government, the pharmaceutical industry, and healthcare professionals, partners, and a positive risk-benefit ratio were significant promoters for COVID-19 vaccine acceptance. Findings from this study suggest that promotional interventions targeting PLW should use web platforms and focus on vaccine safety evidence, the expected benefits of vaccines and potential harms of the infection.

Global Prevalence of COVID-19-Associated Mucormycosis (CAM): Living Systematic Review and Meta-Analysis.

Mucormycosis, a secondary fungal infection, gained much attention in the ongoing COVID-19 pandemic. This deadly infection has a high all-cause mortality rate and imposes a significant economic, epidemiological, and humanistic burden on the patients and healthcare system. Evidence from the published epidemiological studies showed the varying prevalence of COVID-19-associated mucormycosis (CAM). This study aims to compute the pooled prevalence of CAM and other associated clinical outcomes. MEDLINE, Embase, Cochrane COVID-19 Study Register, and WHO COVID-19 databases were scanned to retrieve the relevant articles until August 2021. All studies reporting the prevalence of mucormycosis among COVID-19 patients were eligible for inclusion. Two investigators independently screened the articles against the selection criteria, extracted the data, and performed the quality assessment using the JBI tool. The pooled prevalence of CAM was the primary outcome, and the pooled prevalence of diabetes, steroid exposure, and the mortality rate were the secondary outcomes of interest. Comprehensive Meta-Analysis software version 2 was used for performing the meta-analysis. This meta-analysis comprised six studies with a pooled sample size of 52,916 COVID-19 patients with a mean age of 62.12 ± 9.69 years. The mean duration of mucormycosis onset was 14.59 ± 6.88 days after the COVID-19 diagnosis. The pooled prevalence of CAM (seven cases per 1000 patients) was 50 times higher than the highest recorded background of mucormycosis (0.14 cases per 1000 patients). A high mortality rate was found among CAM patients with a pooled prevalence rate of 29.6% (95% CI: 17.2-45.9%). Optimal glycemic control and the judicious use of steroids should be the approach for tackling rising CAM cases.

Side Effects of mRNA-Based COVID-19 Vaccines among Young Adults (18-30 Years Old): An Independent Post-Marketing Study.

Young adults had been widely perceived as a low-risk group for COVID-19 severity; therefore, they were deprioritised within the mass vaccination strategies as their prognosis of COVID-19 infection is relatively more favourable than older age groups. On the other hand, vaccination of this demographic group is indispensable to achieve herd immunity. A cross-sectional survey-based study was used to evaluate the side effects of mRNA-based COVID-19 vaccines among university students in the Czech Republic. The validated questionnaire was delivered in a digital form, and it consisted of demographic data; COVID-19 vaccine-related anamnesis; and local, systemic, orofacial, and skin-related side effects' prevalence, onset, and duration. Out of the 539 included participants, 70.1% were females and 45.8% were <23 years old. The vast majority (95.2%) reported at least one side effect. The most common side effect was injection site pain (91.8%), followed by fatigue (62.5%), headache (36.4%), and muscle pain (34.9%). The majority of local side effects occurred after both doses (74.4%), while most systemic side effects occurred after the second dose only (56.2%). Most local (94.2%) and systemic (93.3%) side effects resolved within three days after vaccination. Females participants' adjusted odds ratio (AOR) showed they were 2.566 (CI 95%: 1.103-5.970) times more likely to experience post-vaccination side effects, and the participants who received two doses reported an increased AOR of 1.896 (0.708-5.077) for experiencing side effects. The results of this study imply that mRNA-based COVID-19 vaccines are highly probably safe for young adults, and further studies are required to investigate the role of medical anamnesis, prior COVID-19 infection, and gender in side effects incidence.

COVID-19-Associated Mucormycosis (CAM): An Updated Evidence Mapping.

Mucormycosis, a serious and rare fungal infection, has recently been reported in COVID-19 patients worldwide. This study aims to map all the emerging evidence on the COVID-19-associated mucormycosis (CAM) with a special focus on clinical presentation, treatment modalities, and patient outcomes. An extensive literature search was performed in MEDLINE (Ovid), Embase (Ovid), Cochrane COVID-19 Study Register, and WHO COVID-19 database till 9 June 2021. The primary outcome was to summarize the clinical presentation, treatment modalities, and patient outcomes of CAM. Data were summarized using descriptive statistics and presented in tabular form. This evidence mapping was based on a total of 167 CAM patients with a mean age of 51 ± 14.62 years, and 56.28% of them were male. Diabetes mellitus (73.65% (n = 123)), hypertension (22.75% (n = 38)), and renal failure (10.77% (n = 18)) were the most common co-morbidities among CAM patients. The most common symptoms observed in CAM patients were facial pain, ptosis, proptosis, visual acuity, and vision loss. Survival was higher in patients who underwent both medical and surgical management (64.96%). Overall mortality among CAM patients was found to be 38.32%. In conclusion, this study found a high incidence of CAM with a high mortality rate. Optimal glycemic control and early identification of mucormycosis should be the priority to reduce the morbidity and mortality related to CAM.

A taxonomy and framework for identifying and developing actionable statements in guidelines suggests avoiding informal recommendations.

OBJECTIVE: To propose a taxonomy and framework that identifies and presents actionable statements in guidelines. STUDY DESIGN AND SETTING: We took an iterative approach reviewing case studies of guidelines produced by the World Health Organization and the American Society of Hematology to develop an initial conceptual framework. We then tested it using randomly selected recommendations from published guidelines addressing COVID-19 from different organizations, evaluated its results, and refined it before retesting. The urgency and availability of evidence for development of these recommendations varied. We consulted with experts in research methodology and guideline developers to improve the final framework. RESULTS: The resulting taxonomy and framework distinguishes five types of actional statements: formal recommendations; research recommendations; good practice statements; implementation considerations, tools and tips; and informal recommendations. These statements should respond to a priori established criteria and require a clear structure and recognizable presentation in a guideline. Most importantly, this framework identifies informal recommendations that differ from formal recommendations by how they consider evidence and in their development process. CONCLUSION: The identification, standardization and explicit labelling of actionable statements according to the framework may support guideline developers to create actionable statements with clear intent, avoid informal recommendations and improve their understanding and implementation by users.

Predictors of Willingness to Receive COVID-19 Vaccine: Cross-Sectional Study of Palestinian Dental Students.

The overarching aim of this study was to assess the predictors related to the willingness of Palestinian dental students to receive the COVID-19 vaccine when it becomes available. A cross-sectional study was conducted among a universal sample of dental students in the Palestinian territories. Willingness to get the COVID-19 vaccine was related to the following factors: Demographic characteristics, COVID-19-related experiences, beliefs and knowledge about the vaccine, attitudes toward vaccinations in general, and other factors outlined by the WHO SAGE Vaccination Hesitancy Questionnaire. Four hundred and seventeen students completed the questionnaire (response rate = 41.7%). In general, 57.8% (n = 241) were willing to take the COVID-19 vaccine when it became available to them, 27% (n = 114) were hesitant, and 14.9% (n = 62) were not willing to get vaccinated. The final regression model explained 46% of the variation in the willingness to receive the COVID-19 vaccine as follows: Attitudes towards new vaccines (ß = 6.23, p < 0.001), believing in a favorable risk-benefit ratio (ß = 5.64, p < 0.001), trust in the pharmaceutical industry (ß = 5.92, p = 0.001), believing that natural immunity is better than being vaccinated (ß = -4.24, p < 0.001), and having enough information about the vaccine (ß = 4.12, p < 0.001). Adequate information about vaccines, their risk-benefit ratios, and natural and acquired immunity are important to build trust and favorable attitudes towards vaccines among future dentists.

COVID-19 Vaccines Safety Tracking (CoVaST): Protocol of a Multi-Center Prospective Cohort Study for Active Surveillance of COVID-19 Vaccines' Side Effects.

BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.

Prevalence and Risk Factors of CoronaVac Side Effects: An Independent Cross-Sectional Study among Healthcare Workers in Turkey.

BACKGROUND: COVID-19 vaccine hesitancy is a serious threat to mass vaccination strategies that need to be accelerated currently in order to achieve a substantial level of community immunity. Independent (non-sponsored) studies have a great potential to enhance public confidence in vaccines and accelerate their uptake process. METHODS: A nationwide cross-sectional study for the side effects (SE) of CoronaVac was carried out in February 2021 among Turkish healthcare workers who were recently vaccinated. The questionnaire inquired about local and systemic SEs that occurred in the short-term, within four weeks, following vaccination. RESULTS: A total of 780 healthcare workers were included in this study; 62.5% of them experienced at least one SE. Injection site pain (41.5%) was the most common local SE, while fatigue (23.6%), headache (18.7%), muscle pain (11.2%) and joint pain (5.9%) were the common systemic SEs. Female healthcare workers (67.9%) were significantly more affected by local and systemic SEs than male colleagues (51.4%). Younger age, previous infection, and compromised health status (chronic illnesses and regular medicines uptake) can be associated with an increased risk of CoronaVac SEs; Conclusions: The independent research shows a higher prevalence of CoronaVac SEs than what is reported by phase I-III clinical trials. In general, the results of this study confirm the overall safety of CoronaVac and suggest potential risk factors for its SEs. Gender-based differences and SEs distribution among age groups are worth further investigation.

Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States.

Recent reports of thrombosis following AstraZeneca COVID-19 vaccine in young females (<55 years-old) led to temporary suspension and urgent investigation by the European Medicines Agency (EMA) that concluded that vaccine benefits still outweigh its side effects (SEs). Therefore, this study aims to provide early independent evidence on the vaccine SEs' prevalence and their potential risk factors; a cross-sectional survey-based study was carried out between February and March 2021 in Germany and Czech Republic among healthcare workers who recently received the AstraZeneca COVID-19 vaccine. The study used a validated self-administered questionnaire composed of twenty-eight multiple-choice items covering demographic variables, medical anamneses, and local, systemic, oral, and skin related SEs of the vaccine. Out of the ninety-two included participants, 77.2% were females and 79.3% were from Germany. Their mean age was 35.37 ± 12.62 (19-64) years-old, 15.2% had chronic illnesses and 22.8% were receiving medical treatments. Overall, 94.6% of the participants reported at least one SE. The most common local SE was injection site pain (72.8%), and the most common systemic SEs were fatigue (73.9%), muscle pain (55.4%), chills (48.9%), feeling unwell (46.7%), nausea (45.7%), and headache (29.3%). The vast majority (91.9%) resolved within 1-3 days, and the below 35 years-old group was the least affected age group. The SEs' frequency was insignificantly higher in females and previously infected participants; the vaccine safety for the elderly was supported by the early findings of this study. Chronic illnesses and medical treatments were not associated with an increased risk of SE incidence and frequency. No blood disorder SEs were reported in our sample. Further independent studies are highly required to evaluate the safety of the AstraZeneca vaccine and to explore whether gender or previous infection could be associated with the vaccine SEs.

Prevalence of COVID-19 Vaccine Side Effects among Healthcare Workers in the Czech Republic.

BACKGROUND: COVID-19 vaccine side effects have a fundamental role in public confidence in the vaccine and its uptake process. Thus far, the evidence on vaccine safety has exclusively been obtained from the manufacturer-sponsored studies; therefore, this study was designed to provide independent evidence on Pfizer-BioNTech COVID-19 vaccine side effects. METHODS: A cross-sectional survey-based study was carried out between January and February 2021 to collect data on the side effects following the COVID-19 vaccine among healthcare workers in the Czech Republic. The study used a validated questionnaire with twenty-eight multiple-choice items covering the participants' demographic data, medical anamneses, COVID-19-related anamneses, general, oral, and skin-related side effects. RESULTS: Injection site pain (89.8%), fatigue (62.2%), headache (45.6%), muscle pain (37.1%), and chills (33.9%) were the most commonly reported side effects. All the general side effects were more prevalent among the ≤43-year-old group, and their duration was mainly one day (45.1%) or three days (35.8%) following the vaccine. Antihistamines were the most common drugs associated with side effects, thus requiring further investigation. The people with two doses were generally associated with a higher frequency of side effects. CONCLUSIONS: The distribution of side effects among Czech healthcare workers was highly consistent with the manufacturer's data, especially in terms of their association with the younger age group and the second dose. The overall prevalence of some local and systemic side effects was higher than the manufacturer's report. Further independent studies on vaccine safety are strongly required to strengthen public confidence in the vaccine.

Oral Complications of ICU Patients with COVID-19: Case-Series and Review of Two Hundred Ten Cases.

BACKGROUND: The critically ill patients suffering from coronavirus disease (COVID-19) and admitted to the intensive care units (ICUs) are susceptible to a wide array of complications that can be life-threatening or impose them to long-term complications. The COVID-19 oral mucocutaneous complications require multidisciplinary management and research for their pathophysiological course and epidemiological significance; therefore, the objective of this study was to evaluate the prevalence and characteristics of the critically ill COVID-19 patients with oral complications. METHODS: We described the clinical and microbiological characteristics of the critically ill COVID-19 patients in our ICU department (Banska Bystrica, Slovakia). In addition, we reviewed the current body of evidence in Ovid MEDLINE®, Embase, Cochrane Library, and Google Scholar for the oral mucocutaneous complications of ICU patients with COVID-19. RESULTS: Three out of nine critically ill patients (33.3%) in our ICU department presented with oral complications including haemorrhagic ulcers and necrotic ulcers affecting the lips and tongue. The microbiological assessment revealed the presence of opportunistic pathogens, confirming the possibility of co-infection. On reviewing the current literature, two hundred ten critically ill patients were reported to have oral complications due to their stay in the ICU setting. Perioral pressure ulcers were the most common complication, followed by oral candidiasis, herpetic and haemorrhagic ulcers, and acute onset macroglossia. The prolonged prone positioning and mechanical ventilation devices were the primary risk factors for those oral complications, in addition to the immunosuppressive drugs. CONCLUSIONS: The multidisciplinary approach is strongly advocated for monitoring and management of COVID-19 patients, thus implying that dermatology and oral healthcare specialists and nurses should be integrated within the ICU teams.

Developing trustworthy recommendations as part of an urgent response (1-2 weeks): a GRADE concept paper.

OBJECTIVES: The aim of this study is to propose an approach for developing trustworthy recommendations as part of urgent responses (1-2 week) in the clinical, public health, and health systems fields. STUDY DESIGN AND SETTING: We conducted a review of the literature, outlined a draft approach, refined the concept through iterative discussions, a workshop by the Grading of Recommendations Assessment, Development and Evaluation Rapid Guidelines project group, and obtained feedback from the larger Grading of Recommendations Assessment, Development and Evaluation working group. RESULTS: A request for developing recommendations within 2 week is the usual trigger for an urgent response. Although the approach builds on the general principles of trustworthy guideline development, we highlight the following steps: (1) assess the level of urgency; (2) assess feasibility; (3) set up the organizational logistics; (4) specify the question(s); (5) collect the information needed; (6) assess the adequacy of identified information; (7) develop the recommendations using one of the 4 potential approaches: adopt existing recommendations, adapt existing recommendations, develop new recommendations using existing adequate systematic review, or develop new recommendations using expert panel input; and (8) consider an updating plan. CONCLUSION: An urgent response for developing recommendations requires building a cohesive, skilled, and highly motivated multidisciplinary team with the necessary clinical, scientific, and methodological expertise; adapting to shifting needs; complying with the principles of transparency; and properly managing conflicts of interest.