A cohort of 12 000 children in the Philippines who had enrolled in a 2000–2004 (current ages 16 to 20 years) Phase 3 11-valent pneumococcal conjugate vaccine for the prevention of radiographically confirmed pneumonia are now being asked to participate in a separate study (expected completion date September 2021) to assess the cohort’s current long-term audiometric and otologic status. This new study would allow assessments of the utility of the pneumococcal vaccine in conferring its protective effects on the long-term sequelae of otitis media (OM), if any. Lack of trained local healthcare providers in otolaryngology/audiology and testing equipment in Bohol, Philippines, necessitates the development of a distinct methodology that would lead to meaningful data analysis.
Reliable data collection and transfer are achieved by a US otolaryngologist/audiologist team training local nurses on all procedures in a didactic and hands-on process. An assortment of portable otolaryngologic and audiologic equipment suitable for field testing has been acquired, including an operating otoscope (Welch-Allyn), a video-otoscope (JedMed), a tympanometer with distortion product otoacoustic emission measurements (Path Sentiero) and a screening audiometer (HearScreen). Data will then be uploaded to a Research Electronic Data Capture database in the USA.
Tympanometric and audiologic data will be codified through separate conventional algorithms. A team of paediatric otolaryngology advanced practice providers (APPs) have been trained and validated in interpreting video otoscopy. The protocol for classification of diagnostic outcome variables based on video otoscopy and tympanometry has been developed and is being used by APPs to evaluate all otoscopy data.
The study was approved by the Research Institute of Tropical Medicine, Alabang, Manila, Philippines, and the institutional review board and the Colorado Multiple Institutional Review Board of the University of Colorado School of Medicine, Aurora, Colorado, USA.
Research results will be made available to children and their caregivers with abnormal audiologic outcomes, the funders and other researchers.
ISRCTN 62323832; Post-results.
We aim to assess the impact of temperature and relative humidity on the transmission of COVID-19 across communities after accounting for community-level factors such as demographics, socioeconomic status and human mobility status.
A retrospective cross-sectional regression analysis via the Fama-MacBeth procedure is adopted.
We use the data for COVID-19 daily symptom-onset cases for 100 Chinese cities and COVID-19 daily confirmed cases for 1005 US counties.
A total of 69 498 cases in China and 740 843 cases in the USA are used for calculating the effective reproductive numbers.
Regression analysis of the impact of temperature and relative humidity on the effective reproductive number (R value).
Statistically significant negative correlations are found between temperature/relative humidity and the effective reproductive number (R value) in both China and the USA.
Higher temperature and higher relative humidity potentially suppress the transmission of COVID-19. Specifically, an increase in temperature by 1°C is associated with a reduction in the R value of COVID-19 by 0.026 (95% CI (–0.0395 to –0.0125)) in China and by 0.020 (95% CI (–0.0311 to –0.0096)) in the USA; an increase in relative humidity by 1% is associated with a reduction in the R value by 0.0076 (95% CI (–0.0108 to –0.0045)) in China and by 0.0080 (95% CI (–0.0150 to –0.0010)) in the USA. Therefore, the potential impact of temperature/relative humidity on the effective reproductive number alone is not strong enough to stop the pandemic.
Current guidelines do not recommend direct oral anticoagulants (DOACs) to treat cerebral venous thrombosis (CVT) despite their benefits over standard therapy. We performed a systematic review to summarise the published experience of DOAC therapy in CVT.
MEDLINE, Embase and COCHRANE databases up to 18 November 2020.
All published articles of patients with CVT treated with DOAC were included. Studies without follow-up information were excluded.
Two independent reviewers screened articles and extracted data. A risk of bias analysis was performed.
Safety data included mortality, intracranial haemorrhage (ICH) or other adverse events. Efficacy data included recurrent CVT, recanalisation rates and disability by modified Rankin Scales (mRS).
33 studies met inclusion criteria. One randomised controlled trial, 5 observational cohorts and 27 case series or studies reported 279 patients treated with DOAC for CVT: 41% dabigatran, 47% rivaroxaban, 10% apixaban and 2% edoxaban, in addition to 315 patients treated with standard therapy. The observational cohorts showed a similar risk of death in DOAC and standard therapy arms (RR 2.12, 95% CI 0.29 to 15.59). New ICH was reported in 2 (0.7%) DOAC-treated patients and recurrent CVT occurred in 4 (1.5%). A favourable mRS between 0 and 2 was reported in 94% of DOAC-treated patients, more likely than standard therapy in observational cohorts (RR 1.13, 95% CI 1.02 to 1.25).
The evidence for DOAC use in CVT is limited although suggests sufficient safety and efficacy despite variability in timing and dose of treatment. This systematic review highlights that further rigorous trials are needed to validate these findings and to determine optimal treatment regimens.
The Arthritis Self-Efficacy Scale (ASES) was designed to assess the degree of self-efficacy among patients with arthritis. Though the original English version of this instrument has shown a high degree of reliability and validity, a Chinese version of this scale has yet to be validated. Therefore, the aim of this cross-sectional study was to evaluate the psychometric characteristics of the Chinese version of ASES (C-ASES) in a population of Chinese adults with rheumatic diseases (RDs).
After completing backward translation and expert validity, a convenient sample of 258 qualified participants with RDs from a hospital in Taiwan were recruited to explore the content validity, concurrent validity, construct validity, internal consistency reliability and test–retest reliability of C-ASES.
The C-ASES has demonstrated acceptable internal consistency and test–retest reliability, with a Cronbach α of 0.91 and intraclass correlation coefficient of 0.89, respectively. Concurrent validity was acceptable, with significant correlation between the subscales of the C-ASES and perceived depressive symptoms, as measured by the Taiwanese Depression Questionnaire (p
Empirical data support the assertion that C-ASES is a reliable and valid screening instrument to assess self-efficacy in Chinese-speaking patients with RDs. C-ASES may be useful as a reference guide in providing appropriate interventions for bolstering self-efficacy among Chinese-speaking patients with RDs.
Whether ACE inhibitors (ACEi) or angiotensin II receptor blocker (ARB) therapy should be continued, initiated or ceased in patients with COVID-19 is uncertain. Given the widespread use of ACEi/ARBs worldwide, guidance on the use of these drugs is urgently needed. This prospective meta-analysis aims to pool data from randomised controlled trials (RCTs) to assess the safety and efficacy of ACEi/ARB therapy in adults infected with SARS-CoV-2.
RCTs will be eligible if they compare patients with COVID-19 randomised to ACEi/ARB continuation or commencement versuss no ACEi/ARB therapy; study duration ≥14 days; recruitment completed between March 2020 and May 2021. The primary outcome will be all-cause mortality at ≤30 days. Secondary outcomes will include mechanical ventilation, admission to intensive care or cardiovascular events at short-term follow-up (≤30 days) and all-cause mortality at longer-term follow-up (>1 month). Prespecified subgroup analyses will assess the effect of sex; age; comorbidities; smoking status; ethnicity; country of origin on all-cause mortality. A search of ClinicalTrials.gov has been performed, which will be followed by a formal search of trial registers, preprint servers, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials to identify RCTs that meet inclusion criteria. To date, a search of ClinicalTrials.gov identified 21 potentially eligible trials for this meta-analysis. We will request trial investigators/sponsors to contribute standardised grouped tabular outcome data.
Ethics approval and informed consent will be the responsibility of the individual RCTs. Dissemination of results will occur by peer-reviewed publication. The results of our analysis can inform public health policy and clinical decision making regarding ACEi/ARB use in patients with COVID-19 on a global scale.
Implementation research has emerged as part of evidence-based decision-making efforts to plug current gaps in the translation of research evidence into health policy and practice. While there has been a growing number of institutions and initiatives promoting the uptake of implementation research in Africa, their role and effectiveness remain unclear, particularly in the context of universal health coverage (UHC). This review aims to extensively identify and characterise the nature, facilitators and barriers to the use of implementation research for assessing or evaluating UHC-related interventions or programmes in Africa.
This scoping review will be developed based on the methodological framework proposed by Arksey and O’Malley and enhanced by the Joanna Briggs Institute. It will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search of the following electronic databases will be conducted: Medline (via PubMed), Scopus and the Cochrane Library. Relevant grey literature and reference lists will also be searched. All publications describing the application of implementation research in the context of UHC will be considered for inclusion. Findings will be narratively synthesised and analysed using a predefined conceptual framework. Where applicable, quantitative evidence will be aggregated using summary statistics. There will be consultation of stakeholders, including UHC-oriented health professionals, programme managers, implementation researchers and policy-makers; to provide methodological, conceptual and practical insights.
The data used in this review will be sourced from publicly available literature; hence, this study will not require ethical approval. Findings and recommendations will be disseminated to reach a diverse audience, including UHC advocates, implementation researchers and key health system stakeholders within the African region. Additionally, findings will be disseminated through an open-access publication in a relevant peer-reviewed journal.
Chronic kidney disease (CKD) is a common chronic disease. As this disease is extremely complex, multidisciplinary care (MDC) is needed to provide complete and continuous care.
A systematic literature review was performed to examine the constituents of MDC, the content of MDC interventions, and the health outcomes in CKD patients receiving MDC.
Searches of five Chinese and English databases for studies of CKD patients who had received MDC from 2007 to 2019 revealed 11 studies, which comprised 16,066 CKD patients. The Physiotherapy Evidence Database scale (Physiotherapy Evidence Database, 2017) was used to appraise study quality for randomized controlled trials, and the Joanna Briggs Institute Critical Appraisal tools (Joanna Briggs Institute, 2017) were for cohort studies.
The MDC teams that provided comprehensive medical care for these patients included nephrologists, nurses, surgeons, general practitioners, pharmacists, psychotherapists, social workers, nutritionists, and other specialists. The literature review revealed that MDC for CKD slows the decline in estimated glomerular filtration rate and decreases patient mortality, the risk of renal replacement therapy, the need for emergent dialysis, and annual medical costs. Analyses of biochemical markers in the CKD patients showed that MDC improves control of serum levels of calcium and phosphate, improves control of parathyroid hormone, and reduces proteinuria and fasting blood glucose values. However, further studies are needed to determine the effects of MDC on all‐cause mortality, blood pressure control, hospitalization rate, hospitalization for cardiovascular or infection events, medications use, and other biochemical markers in CKD patients.
Cross‐disciplinary collaboration of healthcare professionals is needed to ensure that patients undergo regular follow‐up and periodic assessment of clinical status, in addition to ensuring that relevant resources and assistance are provided in a timely manner. A follow‐up period of at least 2 years is also needed to ensure sufficient time to observe MDC results.
Emergency care clinicians are expected to use the latest research evidence in practice. However, emergency nurses do not always consistently implement evidence‐based practice (EBP). An educational intervention on EBP was implemented to promote emergency nurses’ use of EBP, and the effectiveness of it was evaluated.
This study aimed to evaluate the effectiveness of an EBP educational intervention on emergency nurses’ EBP attitudes, knowledge, self‐efficacy, skills, and behavior. The study also examined learners’ satisfaction with the EBP educational intervention.
A randomized controlled trial with parallel groups with evaluations before the education, immediately after it, and 6 and 12 months after the education was conducted at four emergency departments in two university hospitals. The experimental group (N = 40) received EBP education while the control group (N = 40) completed self‐directed EBP education. The primary outcomes were emergency nurses’ EBP attitudes, knowledge, self‐efficacy, skills, and behavior, while the secondary outcome was satisfaction with the EBP education.
Thirty‐five participants of an experimental and 29 participants of a control group completed the study. There were no statistically significant (p < .05) improvements and differences between groups in EBP attitude, self‐efficacy, or behavior immediately after the EBP education. At the 6‐month measurement point, the experimental group showed significantly better EBP attitudes, behavior, knowledge, and self‐efficacy than the control group. At the 12‐month measurement point, the improvements began to decrease. The groups also differed significantly in terms of participant satisfaction with how the teacher encouraged learners to ask clinical questions.
The EBP educational intervention implemented in this study had a positive effect on emergency nurses’ EBP attitudes, knowledge, self‐efficacy, skills, and behavior. The effects of the education appeared the best 6 months after the education. After this point, the results began to decrease and approached baseline levels. EBP educational interventions designed for emergency nurses should apply various teaching strategies to improve their EBP attitude, knowledge, self‐efficacy, skills, behavior, and satisfaction with the education.
Evidence‐based patient care requires clinicians to make decisions based on the best available evidence and researchers to provide new scientific knowledge. Clinician‐scientists (i.e., registered nurses [RNs] and physicians with a PhD) make important contributions to health care; yet, their roles are not fully understood, supported, or recognized by healthcare leaders. Only a few studies have addressed the factors that enable RNs and physicians to simultaneously pursue both clinical work and research after earning a PhD.
To explore what factors have a bearing on the ability of RNs and physicians to pursue research and clinical work simultaneously after earning a PhD.
The study used a qualitative design based on open‐ended, in‐depth interviews. Data were analyzed using conventional content analysis.
Analysis of the data yielded a broad range of factors that RNs and physicians perceived to either facilitate or hinder continued research while simultaneously undertaking clinical work. Most of the perceived barriers were due to factors external to the individual. Several factors applied to both professions yet differed in impact. Factors mentioned as fundamental to continued research were financial support and allocated time for research. Maintenance of a good relationship with academia and support from management were also considered to be important. In addition, personal factors, such as motivation to pursue a research career after obtaining a PhD, were influential.
A supportive infrastructure is important for enabling clinician‐scientists to pursue research after earning a PhD. Creating favorable conditions for RNs and physicians to combine research with clinical work can facilitate evidence‐based practice. This information can be used for interventions aimed at improving the conditions for clinician‐scientists.
We sought to determine the extent of SARS-CoV-2 seroprevalence and the factors associated with seroprevalence across a diverse cohort of healthcare workers.
Observational cohort study of healthcare workers, including SARS-CoV-2 serology testing and participant questionnaires.
A multisite healthcare delivery system located in Los Angeles County.
A diverse and unselected population of adults (n=6062) employed in a multisite healthcare delivery system located in Los Angeles County, including individuals with direct patient contact and others with non-patient-oriented work functions.
Using Bayesian and multivariate analyses, we estimated seroprevalence and factors associated with seropositivity and antibody levels, including pre-existing demographic and clinical characteristics; potential COVID-19 illness-related exposures; and symptoms consistent with COVID-19 infection.
We observed a seroprevalence rate of 4.1%, with anosmia as the most prominently associated self-reported symptom (OR 11.04, p
The demographic factors associated with SARS-CoV-2 seroprevalence among our healthcare workers underscore the importance of exposure sources beyond the workplace. The size and diversity of our study population, combined with robust survey and modelling techniques, provide a vibrant picture of the demographic factors, exposures and symptoms that can identify individuals with susceptibility as well as potential to mount an immune response to COVID-19.
Diabetes management in very young children remains challenging. Glycaemic targets are achieved at the expense of high parental diabetes management burden and frequent hypoglycaemia, impacting quality of life for the whole family. Our objective is to assess whether automated insulin delivery can improve glycaemic control and alleviate the burden of diabetes management in this particular age group.
The study adopts an open-label, multinational, multicentre, randomised, crossover design and aims to randomise 72 children aged 1–7 years with type 1 diabetes on insulin pump therapy. Following screening, participants will receive training on study insulin pump and study continuous glucose monitoring devices. Participants will be randomised to 16-week use of the hybrid closed-loop system (intervention period) or to 16-week use of sensor-augmented pump therapy (control period) with 1–4 weeks washout period before crossing over to the other arm. The order of the two study periods will be random. The primary endpoint is the between-group difference in time spent in the target glucose range from 3.9 to 10.0 mmol/L based on sensor glucose readings during the 16-week study periods. Analyses will be conducted on an intention-to-treat basis. Key secondary endpoints are between group differences in time spent above and below target glucose range, glycated haemoglobin and average sensor glucose. Participants’ and caregivers’ experiences will be evaluated using questionnaires and qualitative interviews, and sleep quality will be assessed. A health economic analysis will be performed.
Ethics approval has been obtained from Cambridge East Research Ethics Committee (UK), Ethics Committees of the University of Innsbruck, the University of Vienna and the University of Graz (Austria), Ethics Committee of the Medical Faculty of the University of Leipzig (Germany) and Comité National d’Ethique de Recherche (Luxembourg). The results will be disseminated by peer-reviewed publications and conference presentations.
The efficacy of parecoxib as pre-emptive analgesia still remains controversial. This study aimed to investigate how pre-emptive analgesia with parecoxib affected postoperative pain trajectories over time in patients undergoing thoracic surgery.
Retrospective cohort study.
A single medical centre in Taiwan.
We collected 515 patients undergoing video-assisted thoracoscopic surgery at a tertiary medical centre between September 2016 and August 2017.
Pre-emptive parecoxib before surgery.
Daily numeric rating pain scores in the first postoperative week.
A total of 196 (38.1%) of the recruited patients received parecoxib preoperatively. The latent curve analysis revealed that woman, higher body weight and postoperative use of parecoxib were associated with increased baseline level of pain scores over time (p=0.035, 0.005 and 0.048, respectively) but epidural analgesia and preoperative use of parecoxib were inclined to decrease it (both p
Pre-emptive analgesia with parecoxib was associated with decreased baseline pain scores but had no connection with pain decreasing trends over time. Latent curve analysis provided insights into the dynamic relationships among the analgesic modalities, patient characteristics and postoperative pain trajectories.
Socioeconomic disparities in smoking prevalence remain a challenge to public health. The objective of this study was to present a simple methodology that displays intersectional patterns of smoking and quantify heterogeneities within groups to avoid inappropriate and potentially stigmatising conclusions exclusively based on group averages.
This is a cross-sectional observational study based on data from the National Health Surveys for Sweden (2004–2016 and 2018) including 136 301 individuals. We excluded people under 30 years of age, or missing information on education, household composition or smoking habits. The final sample consisted on 110 044 individuals or 80.7% of the original sample.
Applying intersectional analysis of individual heterogeneity and discriminatory accuracy (AIHDA), we investigated the risk of self-reported smoking across 72 intersectional strata defined by age, gender, educational achievement, migration status and household composition.
The distribution of smoking habit risk in the population was very heterogeneous. For instance, immigrant men aged 30–44 with low educational achievement that lived alone had a prevalence of smoking of 54% (95% CI 44% to 64%), around nine times higher than native women aged 65–84 with high educational achievement and living with other(s) that had a prevalence of 6% (95% CI 5% to 7%). The discriminatory accuracy of the information was moderate.
A more detailed, intersectional mapping of the socioeconomic and demographic disparities of smoking can assist in public health management aiming to eliminate this unhealthy habit from the community. Intersectionality theory together with AIHDA provides information that can guide resource allocation according to the concept proportionate universalism.
Patients surviving critical illnesses, such as sepsis, often suffer from long-term complications. After discharge from hospital, most patients are treated in primary care. Little is known how general practitioners (GPs) perform critical illness aftercare and how it can be improved. Within a randomised controlled trial, an outreach training programme has been developed and applied.
The aim of this study is to describe GPs’ views and experiences of caring for postsepsis patients and of participating a specific outreach training.
Semistructured qualitative interviews.
14 primary care practices in the metropolitan area of Berlin, Germany.
14 GPs who had participated in a structured sepsis aftercare programme in primary care.
Themes identified in sepsis aftercare were: continuity of care and good relationship with patients, GP’s experiences during their patient’s critical illness and impact of persisting symptoms. An outreach education as part of the intervention was considered by the GPs to be acceptable, helpful to improve knowledge of the management of postintensive care complications and useful for sepsis aftercare in daily practice.
GPs provide continuity of care to patients surviving sepsis. Better communication at the intensive care unit–GP interface and training in management of long-term complications of sepsis may be helpful to improve sepsis aftercare.
Mortality prediction scores are increasingly being evaluated in low and middle income countries (LMICs) for research comparisons, quality improvement and clinical decision-making. The modified early warning score (MEWS), quick Sequential (Sepsis-Related) Organ Failure Assessment (qSOFA), and Universal Vital Assessment (UVA) score use variables that are feasible to obtain, and have demonstrated potential to predict mortality in LMIC cohorts.
To determine the predictive capacity of adapted MEWS, qSOFA and UVA in a Rwandan hospital.
We prospectively collected data on all adult patients admitted to a tertiary hospital in Rwanda with suspected infection over 7 months. We calculated an adapted MEWS, qSOFA and UVA score for each participant. The predictive capacity of each score was assessed including sensitivity, specificity, positive and negative predictive value, OR, area under the receiver operating curve (AUROC) and performance by underlying risk quartile.
We screened 19 178 patient days, and enrolled 647 unique patients. Median age was 35 years, and in-hospital mortality was 18.1%. The proportion of data missing for each variable ranged from 0% to 11.7%. The sensitivities and specificities of the scores were: adapted MEWS >4, 50.4% and 74.9%, respectively; qSOFA >2, 24.8% and 90.4%, respectively; and UVA >4, 28.2% and 91.1%, respectively. The scores as continuous variables demonstrated the following AUROCs: adapted MEWS 0.69 (95% CI 0.64 to 0.74), qSOFA 0.65 (95% CI 0.60 to 0.70), and UVA 0.71 (95% CI 0.66 to 0.76); there was no statistically significant difference between the discriminative capacities of the scores.
Three scores demonstrated a modest ability to predict mortality in a prospective study of inpatients with suspected infection at a Rwandan tertiary hospital. Careful consideration must be given to their adequacy before using them in research comparisons, quality improvement or clinical decision-making.
Antimicrobial treatment of asymptomatic bacteriuria (ASB) is one of the most common unnecessary uses of antimicrobials. Earlier studies have shown that the prevalence of this inappropriate treatment ranges from 45% to 83%. Multifaceted interventions based on international guidelines and antimicrobial stewardship can decrease overtreatment of ASB. We have designed a study protocol with the main objective of reducing overtreatment of ASB by 50% through use of a deimplementation strategy.
We will use a stepped-wedge cluster randomised design, comparing outcomes before and after introduction of our intervention in the emergency department (ED) of five hospitals (clusters) in the Netherlands. All patients (≥18 years old) who have a urine test performed in the ED will be screened for eligibility. The deimplementation strategy consists of a combination of interventions, including education, audit and feedback. The primary endpoint is overtreatment of ASB in patients without risk factors (eg, pregnancy, planned invasive urological procedures and neutropenia). Secondary endpoints are the duration of antimicrobial treatment for ASB, the number of urine cultures and urinalysis per 1000 patients, and overtreatment of positive urinalysis in asymptomatic patients.
Ethical approval was obtained from the medical ethics research committee of the Academic Medical Centre (Amsterdam, the Netherlands) with a waiver for informed consent. Local feasibility was obtained by the local institutional review boards of all participating hospitals. Our study aims to reduce inappropriate screening and treatment of ASB in EDs, improve healthcare quality, lower the increase in antimicrobial resistance and save costs. If proven (cost)-effective, this study provides a well-suited strategy for a nationwide approach to reduce overtreatment of ASB. Relevant results of our study will be disseminated through publications in peer-reviewed journals and presentations at relevant (scientific) conferences.
We studied time trends in seasonal influenza vaccination and associations with socioeconomic and health-related determinants in Switzerland, overall and in people aged ≥65 years.
Three cross-sectional surveys.
Individuals who participated in the Swiss Health Surveys 2007, 2012 and 2017. We calculated the proportion reporting influenza vaccination in the last 12 months, and performed multivariable logistic regression analyses.
We included 51 582 individuals in this analysis. The median age was 49 years (IQR 25–64), and 27 518 were women (53.3%). The proportion of reporting a history of influenza vaccination overall was 31.9% (95% CI 31.4 to 32.4); and dropped from 34.5% in 2007 to 28.8% in 2017. The uptake of vaccination within the past 12 months was 16% in 2007 and similar in 2012 and 2017 (around 14%). In people with chronic disease, uptake dropped from 43.8% in 2007 to 37.1% in 2012 and to 31.6% in 2017 (p
Influenza vaccination coverage was low in older and chronically ill persons. Significant efforts are required in preparing for the influenza season 2020/2021 to reduce the double burden of COVID-19 and seasonal influenza. These efforts should include campaigns but also novel approaches using social media.