Up to 50% of patients develop post-thrombotic syndrome (PTS) after an above knee deep vein thrombosis (DVT). The aim of the study was to determine the effect of graduated compression stockings in preventing PTS after DVT.
Pragmatic, UK multicentre randomised trial in adults with first above knee DVT. The standard of care arm is anticoagulation. The intervention arm will receive anticoagulation plus stockings (European class II, 23–32 mm Hg compression) worn for a median of 18 months. The primary endpoint is PTS using the Villalta score. Analysis of this will be through a time to event approach and cumulative incidence at median 6, 12 and 18 months. An ongoing process evaluation will examine factors contributing to adherence to stockings to understand if and how the behavioural interventions were effective.
UK research ethics committee approval (reference 19/LO/1585). Dissemination though the charity Thrombosis UK, the Imperial College London website, peer-reviewed publications and international conferences.
ISRCTN registration number 73041168.
Chiari 1 malformation (CM1) is a structural abnormality of the hindbrain characterised by the descent of the cerebellar tonsils through the foramen magnum. The management of patients with CM1 remains contentious since there are currently no UK or international guidelines for clinicians. We therefore propose a collaborative, prospective, multicentre study on the investigation, management and outcome of CM1 in the UK: the UK Chiari 1 Study (UKC1S). Our primary objective is to determine the health-related quality of life (HRQoL) in patients with a new diagnosis of CM1 managed either conservatively or surgically at 12 months of follow-up. We also aim to: (A) determine HRQoL 12 months following surgery; (B) measure complications 12 months following surgery; (C) determine the natural history of patients with CM1 treated conservatively without surgery; (D) determine the radiological correlates of presenting symptoms, signs and outcomes; and (E) determine the scope and variation within UK practice in referral patterns, patient pathways, investigations and surgical decisions.
The UKC1S will be a prospective, multicentre and observational study that will follow the British Neurosurgical Trainee Research Collaborative model of collaborative research. Patients will be recruited after attending their first neurosurgical outpatient clinic appointment. Follow-up data will be collected from all patients at 12 months from baseline regardless of whether they are treated surgically or not. A further 12-month postoperative follow-up timepoint will be added for patients treated with decompressive surgery. The study is expected to last three years.
The UKC1S received a favourable ethical opinion from the East Midlands Leicester South Research Ethics Committee (REC reference: 20/EM/0053; IRAS 269739) and the Health Research Authority. The results of the study will be published in peer-reviewed medical journals, presented at scientific conferences, shared with collaborating sites and shared with participant patients if they so wish.
To examine changes in the screening, diagnosis, treatment and management of drug-resistant tuberculosis (DRTB) patients, and investigate the impacts of DRTB-related policies on patients of different demographic and socioeconomic characteristics.
A retrospective cohort study using registry data, plus a survey on DRTB-related policies.
All prefecture-level Centres for Disease Control in Zhejiang Province, China.
Alongside the care cascade, we examined: (1) reported number of presumptive DRTB patients; (2) percentage of presumptive patients with drug susceptibility testing (DST) records; (3) percentage of DRTB/rifampicin-resistant (RR) patients registered; (4) percentage of RR/multidrug-resistant TB (MDRTB) patients that received anti-DRTB treatment; and (5) percentage of RR/MDRTB patients cured/completed treatment among those treated. Multivariate logistic regressions were conducted to explore the impacts of DRTB policies after adjusting for other factors.
The number of reported presumptive DRTB patients and the percentage with DST records largely increased during 2015–2018, and the percentage of registered patients who received anti-DRTB treatment also increased from 59.0% to 86.5%. Patients under the policies of equipping GeneXpert plus expanded criteria for DST had a higher likelihood of being registered compared with no GeneXpert (adjusted OR (aOR)=2.57, 95% CI: 1.20 to 5.51), while for treatment initiation the association was only significant when further expanding the registration criteria (aOR=2.38, 95% CI: 1.19 to 4.79). Patients with registered residence inside Zhejiang were more likely to be registered (aOR=1.96, 95% CI: 1.52 to 2.52), treated (aOR=3.83, 95% CI: 2.78 to 5.28) and complete treatment (aOR=1.92, 95% CI: 1.03 to 3.59) compared with those outside.
The policy changes on DST and registration have effectively improved DRTB case finding and care. Nevertheless, challenges remain in servicing vulnerable groups such as migrants and improving equity in the access to TB care. Future policies should provide comprehensive support for migrants to complete treatment at their current place of residence.
by Hiroko Enomoto, James Yeatts, Liliana Carbajal, B. Radha Krishnan, Jay P. Madan, Sandeep Laumas, Anthony T. Blikslager, Kristen M. MessengerThere is no FDA approved therapy for the treatment of celiac disease (CeD), aside from avoidance of dietary gluten. Larazotide acetate (LA) is a first in class oral peptide developed as a tight junction regulator, which is a lead candidate for management of CeD. A delayed release formulation was tested in vitro and predicted release in the mid duodenum and jejunum, the target site of CeD. The aim of this study was to follow the concentration versus time profile of orally administered LA in the small intestine using a porcine model. A sensitive liquid chromatography/tandem mass spectrometry method was developed to quantify LA concentrations in porcine intestinal fluid samples. Oral dosing of LA (1 mg total) in overnight fasted pigs resulted in time dependent appearance of LA in the distal duodenum and proximal jejunum. Peak LA concentrations (0.32–1.76 μM) occurred at 1 hour in the duodenum and in proximal jejunum following oral dosing, with the continued presence of LA (0.02–0.47 μM) in the distal duodenum and in proximal jejunum (0.00–0.43 μM) from 2 to 4 hours following oral dosing. The data shows that LA is available in detectable concentrations at the site of CeD.
This study aimed to examine the association between workload and patient safety culture (PSC) among intensive care unit (ICU) nurses.
ICU nurses play a vital role in promoting patient safety and are essential indicators in any healthcare system including ICUs. Research studies focusing on the relationship between nursing workload and PSC among ICU nurses are limited.
Descriptive correlational design.
The study participants involved 380 ICU nurses at two hospitals in Riyadh, Saudi Arabia. Data were collected between February 2019–April 2019 and were analysed using SPSS v.22 statistical software. This study was guided by the STROBE checklist.
The results showed that ICU nurses have high positive perceptions in the following PSC subscales: teamwork within units, organisational learning–continuous improvement, frequency of events reported, feedback and communication about error, management support for patient safety, teamwork across units, supervisor/manager expectations and actions promoting patient safety, handoffs and transitions, nonpunitive response to errors, staffing and overall perceptions of patient safety. However, the participants collectively considered the overall grade on patient safety as poor. The participants had high mean scores in physical demand, effort, mental demand and overall workload. A statistically significant variability existed in the mean scores of the PSC subscales and workload of ICU nurses. The overall workload was significantly and negatively associated with the PSC perceptions of ICU nurses.
The ICU nurses experienced high overall workload, physical demand, effort and mental demand which influenced the poor grade of their overall perceived PSC.
Identifying differences and associations with the perceptions of ICU nurses regarding workload and PSC is important because such perceptions may affect their delivery of nursing care. Hospital and nursing administrators must use the study results to find strategies that address workload issues and enhance patient safety.
To explore final‐year nursing students’ perceptions of general practice nursing.
The need for general practice nurses has increased due to growing demands for health care in the community. This demand is exacerbated by a shortage in the general practice nursing workforce. Understanding final‐year nursing students’ perceptions of general practice nursing is important as these may influence career choices.
Qualitative descriptive study within a mixed methods project.
Telephone interviews were conducted with sixteen final‐year nursing students. Interviews were audio‐recorded, transcribed verbatim and analysed using thematic analysis. Reporting follows the COREQ checklist.
Perceptions of general practice nursing varied between participants and related to three main themes; ways of working; a broad role to meet diverse health needs; and relationships with patients. General practice nurses were seen to have stable and collaborative working relationships, with their role ranging from supporting general practitioners to being autonomous professionals. The nurse's broad role was associated with diverse presentations and was considered interesting and challenging. Participants perceived that general practice nurses had more time to spend with patients, and this helped establish trust, and facilitated patient‐centred care.
Participants’ perceptions of general practice nursing varied, with some students recognising the diversity of the role and others perceiving it as limited. These views were often impacted by others experiences rather than personal experience. These variations underscore the need for students to receive greater exposure to general practice nursing. Review of undergraduate curricula to increase focus on preparing nursing students to work in general practice may help shape students’ interest to seek employment in this setting.
Students perceptions of a clinical setting can influence their career decisions. Understanding these perceptions can inform clinicians and managers and highlight areas that may need to be addressed to promote career opportunities.
Clinical teaching visits (CTVs) are formative workplace-based assessments that involve a senior general practitioner (GP) observing a clinical practice session of a general practice registrar (specialist vocational GP trainee). These visits constitute a key part of Australian GP training. Despite being mandatory and resource-intensive, there is a paucity of evidence regarding the content and educational utility of CTVs. This study aims to establish the content and educational utility of CTVs across varying practice settings within Australia, as perceived by registrars and their assessors (‘CT visitors’). In addition, this study aims to establish registrar, CT visitor and practice factors associated with CTV content and perceived CTV utility ratings.
This study will collect data prospectively using online questionnaires completed soon after incident CTVs. Participants will be registrars and CT visitors of CTVs conducted from March 2020 to January 2021. The setting is three Regional Training Organisations across four Australian states and territories (encompassing 37% of Australian GP registrars).
Outcome factors will be a number of specified CTV content elements occurring during the CTV as well as participants’ perceptions of CTV utility, which will be analysed using univariate and multivariable regression.
Ethics approval has been granted by the University of Newcastle Human Research Ethics Committee, approval number H-2020-0037. Study findings are planned to be disseminated via conference presentation, peer-reviewed journals, educational practice translational workshops and the GP Synergy research subwebsite.
To comprehensively map the existing evidence assessing the impact of travel-related control measures for containment of the SARS-CoV-2/COVID-19 pandemic.
Rapid evidence map.
MEDLINE, Embase and Web of Science, and COVID-19 specific databases offered by the US Centers for Disease Control and Prevention and the WHO.
We included studies in human populations susceptible to SARS-CoV-2/COVID-19, SARS-CoV-1/severe acute respiratory syndrome, Middle East respiratory syndrome coronavirus/Middle East respiratory syndrome or influenza. Interventions of interest were travel-related control measures affecting travel across national or subnational borders. Outcomes of interest included infectious disease, screening, other health, economic and social outcomes. We considered all empirical studies that quantitatively evaluate impact available in Armenian, English, French, German, Italian and Russian based on the team’s language capacities.
We extracted data from included studies in a standardised manner and mapped them to a priori and (one) post hoc defined categories.
We included 122 studies assessing travel-related control measures. These studies were undertaken across the globe, most in the Western Pacific region (n=71). A large proportion of studies focused on COVID-19 (n=59), but a number of studies also examined SARS, MERS and influenza. We identified studies on border closures (n=3), entry/exit screening (n=31), travel-related quarantine (n=6), travel bans (n=8) and travel restrictions (n=25). Many addressed a bundle of travel-related control measures (n=49). Most studies assessed infectious disease (n=98) and/or screening-related (n=25) outcomes; we found only limited evidence on economic and social outcomes. Studies applied numerous methods, both inferential and descriptive in nature, ranging from simple observational methods to complex modelling techniques.
We identified a heterogeneous and complex evidence base on travel-related control measures. While this map is not sufficient to assess the effectiveness of different measures, it outlines aspects regarding interventions and outcomes, as well as study methodology and reporting that could inform future research and evidence synthesis.
To conduct a scoping review that (1) describes what is known about the relationship between athletic identity and sport-related injury outcomes and (2) describes the relationship that an injury (as an exposure) has on athletic identity (as an outcome) in athletes.
A total of n=1852 athletes from various sport backgrounds and levels of competition.
The primary measure used within the studies identified was the Athletic Identity Measurement Scale. Secondary outcome measures assessed demographic, psychosocial, behavioural, physical function and pain-related constructs.
Twenty-two studies were identified for inclusion. Samples were dominated by male, Caucasian athletes. The majority of studies captured musculoskeletal injuries, while only three studies included sport-related concussion. Athletic identity was significantly and positively associated with depressive symptom severity, sport performance traits (eg, ego-orientation and mastery-orientation), social network size, physical self-worth, motivation, rehabilitation overadherence, mental toughness and playing through pain, as well as injury severity and functional recovery outcomes. Findings pertaining to the association that an injury (as an exposure) had on athletic identity (as an outcome) were inconsistent and limited.
Athletic identity was most frequently associated with psychosocial, behavioural and injury-specific outcomes. Future research should seek to include diverse athlete samples (eg, women, athletes of different races, para-athletes) and should continue to reference theoretical injury models to inform study methodologies and to specify variables of interest for further exploration.
To translate and adapt the Chelsea Critical Care Physical Assessment Tool (CPAx) into Chinese version (‘CPAx-Chi’), test the reliability and validity of CPAx-Chi, and verify the cut-off point for the diagnosis of intensive care unit-acquired weakness (ICU-AW).
Cross-sectional observational study.
Forward and back translation, cross-cultural adaptation and pretesting of CPAx into CPAx-Chi were based on the Brislin model. Participants were recruited from the general ICU of five third-grade class-A hospitals in western China. Two hundred critically ill adult patients (median age: 53 years; 64% men) with duration of ICU stay ≥48 hours and Glasgow Coma Scale ≥11 were included in this study. Two researchers simultaneously and independently assessed eligible patients using the Medical Research Council Muscle Score (MRC-Score) and CPAx-Chi.
The content validity index of items was 0.889. The content validity index of scale was 0.955. Taking the MRC-Score scale as standard, the criterion validity of CPAx-Chi was r=0.758 (p
CPAx-Chi demonstrated content validity, criterion-related validity and reliability. CPAx-Chi showed the best accuracy in assessment of patients at risk of ICU-AW with good sensitivity and specificity at a recommended cut-off of 31.
With the acute shortage of human resources and infrastructure, mobile phones can be a critical tool for accessing health services and strengthening health systems in Bangladesh. Yet, there is a scarcity of evidence on the use of mobile phones in this context for accessing health services. In this study, we sought to explore the current use of mobile phones for accessing maternal and child healthcare and its determinants among recently delivered women in urban slums of Bangladesh.
The data were collected through interviewing 800 recently delivered women from eight slums of Dhaka city of Bangladesh during May and June 2018. The study followed a cross-sectional design and a two-stage cluster random sampling procedure was followed. A pretested structured questionnaire was employed to collect information. Chi square tests were performed for descriptive analyses and a multilevel binary logistic regression model was executed to explore the determinants of mobile phone usage for accessing maternal and childcare among the participants.
Overall, 73.8% of study participants used mobile phones for accessing maternal and child healthcare. After adjusting for potential confounders, participants’ age, husband’s occupation, sex of household head, women’s ownership of mobile phones and household wealth status were found to be significantly associated with higher odds of using mobile phones to access maternal and child healthcare.
The study highlighted the possibility of implementing large-scale mobile health (mHealth) interventions in slum settlements for accessing maternal and child healthcare and is a sustainable mitigation strategy for the acute health worker crisis in Bangladesh. The findings of this study are particularly crucial for policymakers and practitioners while they revise the health policy to incorporate mHealth interventions as highlighted in the recently initiated Digital Health Strategy of Bangladesh.
Antenatal and postnatal cares are crucial for the survival and well-being of both the mother and the child. WHO recommends a minimum of four antenatal care (ANC) visits during a pregnancy. In Ethiopia, only 38% of women in the reproductive age make a minimum of first ANC visits. This value is far below the typical rates of least developed countries. This study aimed to calculate the magnitude and identify associated factors of ANC service utilisation among pregnant women in Ethiopia.
Cross-sectional study design.
A total of 7913 pregnant women participated in the study.
Antenatal care service uptake among pregnant women.
Only 35.5% of the pregnant mothers have used ANC services at least four times and 64.5% of the pregnant mothers have used less than three times during their periods of pregnancy. The study showed that rich women (PR=1.077, 95% CI: 1.029 to 1.127), having access to mass media (PR=1.086, 95% CI: 1.045 to 1.128), having pregnancy complications (PR=1.203, 95% CI: 1.165 to 1.242), secondary education and above (PR=1.112, 95% CI:1.052 to 1.176), husbands’ having secondary education and above (PR=1.085, 95% CI: 1.031 to 1.142) and married (PR=1.187; 95% CI: 1.087 to 1.296), rural women (PR=0.884, 95% CI: 0.846 to 0.924) and women>30 years of age (PR=1.067, 95% CI: 1.024 to 1.111) significantly associated with the ANC service uptake.
The magnitude of ANC service uptake was low. This low magnitude of ANC service utilisation calls for a need to improve community awareness about maternal health. More importantly, intensive health education is required for pregnant women to have better ANC service uptake and follow-up adherence.
Amidst growing consensus that stakeholder decision-making during drug development should be informed by an understanding of patient preferences, the Innovative Medicines Initiative project ‘Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle’ (PREFER) is developing evidence-based recommendations about how and when patient preferences should be integrated into the drug life cycle. This protocol describes a PREFER clinical case study which compares two preference elicitation methodologies across several populations and provides information about benefit–risk trade-offs by those at risk of rheumatoid arthritis (RA) for preventive interventions.
This mixed methods study will be conducted in three countries (UK, Germany, Romania) to assess preferences of (1) first-degree relatives (FDRs) of patients with RA and (2) members of the public. Focus groups using nominal group techniques (UK) and ranking surveys (Germany and Romania) will identify and rank key treatment attributes. Focus group transcripts will be analysed thematically using the framework method and average rank orders calculated. These results will inform the treatment attributes to be assessed in a survey including a discrete choice experiment (DCE) and a probabilistic threshold technique (PTT). The survey will also include measures of sociodemographic variables, health literacy, numeracy, illness perceptions and beliefs about medicines. The survey will be administered to (1) 400 FDRs of patients with RA (UK); (2) 100 FDRs of patients with RA (Germany); and (3) 1000 members of the public in each of UK, Germany and Romania. Logit-based approaches will be used to analyse the DCE and imputation and interval regression for the PTT.
This study has been approved by the London-Hampstead Research Ethics Committee (19/LO/0407) and the Ethics Committee of the Friedrich-Alexander-Universität Erlangen-Nürnberg (92_17 B). The protocol has been approved by the PREFER expert review board. The results will be disseminated widely and will inform the PREFER recommendations.
Mild motor difficulties in children are underdiagnosed despite being highly prevalent, leaving such children often underserved and at higher risk for secondary consequences such as cardiovascular disease and anxiety. Evidence suggests that early patient-oriented interventions, coaching parents and providing children with early stimulation should be provided, even in the absence of a diagnosis. Such interventions may be effectively delivered via telerehabilitation.
A family-centred, pragmatic randomised controlled trial will be carried out to evaluate the real-world effectiveness of a Web-based Early intervention for Children using multimodAl REhabilitation (WECARE). Families of children with motor difficulties, 3–8 years of age, living in Quebec, Canada, and receiving no public rehabilitation services (n=118) will be asked to determine up to 12 performance goals, evaluated using the Canadian Occupational Performance Measure (COPM, the primary outcome). Families will be randomised to receive either usual care or the WECARE intervention. The WECARE intervention will be delivered for 1 year via a web-based platform. Families will have access to videoconferences with an assigned rehabilitation therapist using a collaborative coaching approach, a private chat function, a forum open to all intervention arm participants and online resources pertaining to child development. Participants will be asked to re-evaluate the child’s COPM performance goals every 3 months up to 1 year post allocation. The COPM results will be analysed using a mixed Poisson regression model. Secondary outcomes include measures of the child’s functional ability, parental knowledge and skills and health-related quality of life, as well as qualitative outcomes pertaining to parental satisfaction and service delivery trajectories. Investigators and quantitative data analysts will be blinded to group allocation.
The CIUSSS de l’Estrie—CHUS ethics committee approved this trial (2020-3429). Study results will be communicated via peer-reviewed journal publications, conference presentations and stakeholder-specific knowledge transfer activities.
Health systems across the world are facing challenges with shortages and maldistribution of skilled health professionals. Return-of-service (ROS) initiatives are government-funded strategies used to educate health professionals by contracting beneficiaries to undertake government work on a year-for-year basis after their qualification. It is envisaged that once they have served their contract, they will be attracted to serve in the same area or government establishment beyond the duration of their obligatory period. Little is known about the processes that led to the development and implementation of ROS policies. Furthermore, there is no systematic evaluation of the strategies that demonstrate their utility. This research aims to evaluate the ROS initiatives, explore their efficacy and sustainability in five Southern African countries.
This study will be conducted in South Africa, Eswatini, Lesotho, Botswana and Namibia in a phased approach through a multimethods approach of policy reviews, quantitative and qualitative research. First, a review will be conducted to explore current ROS schemes. Second, a quantitative retrospective cohort study of ROS scheme recipients for the period 2000–2010 will be undertaken. Information will be sourced from multiple provincial or national information systems and/or databases. Third, we will conduct semistructured group or individual interviews with senior health, education, ROS managing agency managers (where appropriate) and finance managers and/policy makers in each country to determine managers’ perceptions, challenges and the costs and benefits of these schemes. Fourth, we will interview or conduct group discussions with health professional regulatory bodies to assess their willingness to collaborate with ROS initiative funders.
Ethics approval for this study was obtained through the Human Research Ethics Committees of the University of New South Wales (HC200519), Australia; South Africa and Lesotho (065/2020); Eswatini (SHR302/2020); Namibia (SK001); and Botswana (HPDME 13/18/1). Relevant findings will be shared through presentations to participating governments, publications in peer-reviewed journals and presentations at relevant conferences.
Individuals with schizophrenia are at a high risk of physical health comorbidities and premature mortality. Cardiovascular and metabolic causes are an important contributor. There are gaps in monitoring, documenting and managing these physical health comorbidities. Because of their condition, patients themselves may not be aware of these comorbidities and may not be able to follow a lifestyle that prevents and manages the complications. In many low-income and middle-income countries including Pakistan, the bulk of the burden of care for those struggling with schizophrenia falls on the families.
To determine the rate of self-reported physical health disorders and risk factors, like body mass index (BMI) and smoking, associated with cardiovascular and metabolic disorders in cases of schizophrenia compared with a group of mentally healthy controls.
A case-controlled, cross-sectional multicentre study of patients with schizophrenia in Pakistan.
Multiple data collection sites across the country for patients, that is, public and private psychiatric OPDs (out patient departments), specialised psychiatric care facilities, and psychiatric wards of teaching and district level hospitals. Healthy controls were enrolled from the community.
We report a total of 6838 participants’ data with (N 3411 (49.9%)) cases of schizophrenia compared with a group of healthy controls (N 3427 (50.1%)).
BMI (OR 0.98 (CI 0.97 to 0.99), p=0.0025), and the rate of smoking is higher in patients with schizophrenia than in controls. Problems with vision (OR 0.13 (0.08 to 0.2), joint pain (OR 0.18 (0.07 to 0.44)) and high cholesterol (OR 0.13 (0.05 to 0.35)) have higher reported prevalence in controls. The cases describe more physical health disorders in the category ‘other’ (OR 4.65 (3.01 to 7.18)). This captures residual disorders not listed in the questionnaire.
Participants with schizophrenia in comparison with controls report more disorders. The access in the ‘other’ category may be a reflection of undiagnosed disorders.
The evolution of healthcare and biomedical research into data-rich fields has raised several questions concerning data ownership. In this paper, we aimed to analyse the perspectives of Swiss experts on the topic of health data ownership and control.
In our qualitative study, we selected participants through purposive and snowball sampling. Interviews were recorded, transcribed verbatim and then analysed thematically.
Semi-structured interviews were conducted in person, via phone or online.
We interviewed 48 experts (researchers, policy makers and other stakeholders) of the Swiss health-data framework.
We identified different themes linked to data ownership. These include: (1) the data owner: data-subjects versus data-processors; (2) uncertainty about data ownership; (3) labour as a justification for data ownership and (4) the market value of data. Our results suggest that experts from Switzerland are still divided about who should be the data owner and also about what ownership would exactly mean. There is ambivalence between the willingness to acknowledge patients as the data owners and the fact that the effort made by data-processors (eg, researchers) to collect and manage the data entitles them to assert ownership claims towards the data themselves. Altogether, a tendency to speak about data in market terms also emerged.
The development of a satisfactory account of data ownership as a concept to organise the relationship between data-subjects, data-processors and data themselves is an important endeavour for Switzerland and other countries who are developing data governance in the healthcare and research domains. Setting clearer rules on who owns data and on what ownership exactly entails would be important. If this proves unfeasible, the idea that health data cannot truly belong to anyone could be promoted. However, this will not be easy, as data are seen as an asset to control and profit from.
To identify various systolic blood pressure (SBP) trajectories in Chinese boys between 7 and 18 years of age, and to explore their high blood pressure (HBP) risk in their late adolescence years.
A population-based cohort study in Guangdong, China.
4541 normal tensive boys who started primary school in 2005 in Zhongshan, Guangdong were included.
Blood pressure and relevant measurements were obtained by annual physical examinations between 2005 and 2016. HBP was defined by SBP or diastolic blood pressure ≥95th percentile for children under 13, and BP ≥130/80 mm Hg for children ≥13 years old. Logit regression for panel data and log-binomial regression model was used to estimate the risk of HBP among SBP trajectory groups.
Four distinct SBP trajectory groups via group-based trajectory modelling: low stable (13.0%), low rising (42.4%), rising (37.4%) and high rising (7.3%). The overall incidence rates of HBP during the follow-up ranged from 40.24 (95% CI 36.68 to 44.19)/1000 person-years in the low stable group to 97.08 (95% CI 94.93 to 99.27)/1000 person-years in the high rising group. Compared with children with low stable SBP, those of other SBP trajectories suffered 3.05 (95% CI 2.64 to 3.46) to 4.64 (95% CI 4.18 to 5.09) times of higher risk of HBP in their late adolescence, regardless of their age, body mass index and BP level at baseline.
Subgroups of SBP trajectories existed in Chinese boys, and are related to hypertension risk at late adolescence. Regular physical examinations could help identify those with higher risks at the beginning of pubertal growth.
To assess predictive performance of universal early warning scores (EWS) in disease subgroups and clinical settings.
Medline, CINAHL, Embase and Cochrane database of systematic reviews from 1997 to 2019.
Randomised trials and observational studies of internal or external validation of EWS to predict deterioration (mortality, intensive care unit (ICU) transfer and cardiac arrest) in disease subgroups or clinical settings.
We identified 770 studies, of which 103 were included. Study designs and methods were inconsistent, with significant risk of bias (high: n=16 and unclear: n=64 and low risk: n=28). There were only two randomised trials. There was a high degree of heterogeneity in all subgroups and in national early warning score (I2=72%–99%). Predictive accuracy (mean area under the curve; 95% CI) was highest in medical (0.74; 0.74 to 0.75) and surgical (0.77; 0.75 to 0.80) settings and respiratory diseases (0.77; 0.75 to 0.80). Few studies evaluated EWS in specific diseases, for example, cardiology (n=1) and respiratory (n=7). Mortality and ICU transfer were most frequently studied outcomes, and cardiac arrest was least examined (n=8). Integration with electronic health records was uncommon (n=9).
Methodology and quality of validation studies of EWS are insufficient to recommend their use in all diseases and all clinical settings despite good performance of EWS in some subgroups. There is urgent need for consistency in methods and study design, following consensus guidelines for predictive risk scores. Further research should consider specific diseases and settings, using electronic health record data, prior to large-scale implementation.
The acute respiratory distress syndrome (ARDS) is a highly relevant entity in critical care with mortality rates of 40%. Despite extensive scientific efforts, outcome-relevant therapeutic measures are still insufficiently practised at the bedside. Thus, there is a clear need to adhere to early diagnosis and sufficient therapy in ARDS, assuring lower mortality and multiple organ failure.
In this quality improvement strategy (QIS), a decision support system as a mobile application (ASIC app), which uses available clinical real-time data, is implemented to support physicians in timely diagnosis and improvement of adherence to established guidelines in the treatment of ARDS. ASIC is conducted on 31 intensive care units (ICUs) at 8 German university hospitals. It is designed as a multicentre stepped-wedge cluster randomised QIS. ICUs are combined into 12 clusters which are randomised in 12 steps. After preparation (18 months) and a control phase of 8 months for all clusters, the first cluster enters a roll-in phase (3 months) that is followed by the actual QIS phase. The remaining clusters follow in month wise steps. The coprimary key performance indicators (KPIs) consist of the ARDS diagnostic rate and guideline adherence regarding lung-protective ventilation. Secondary KPIs include the prevalence of organ dysfunction within 28 days after diagnosis or ICU discharge, the treatment duration on ICU and the hospital mortality. Furthermore, the user acceptance and usability of new technologies in medicine are examined. To show improvements in healthcare of patients with ARDS, differences in primary and secondary KPIs between control phase and QIS will be tested.
Ethical approval was obtained from the independent Ethics Committee (EC) at the RWTH Aachen Faculty of Medicine (local EC reference number: EK 102/19) and the respective data protection officer in March 2019. The results of the ASIC QIS will be presented at conferences and published in peer-reviewed journals.