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.
This study aims to define appropriate domains and items for the development of a self-administered questionnaire to assess the risk of developing work-related musculoskeletal disorder (WMSD) and the risk of its progression to chronicity.
Literature review and survey study.
A literature review and a two-round interview with 15 experts in musculoskeletal pain were performed to identify the available domains for WMSD assessment.
To ensure quality, only validated questionnaires were included for the Delphi process. A three-round Delphi method, with three round steps, was used to select the most pertinent and relevant domains and items.
Nine questionnaires were identified through the expert discussion and literature review, comprising 38 candidate domains and 504 items. In the first round of the Delphi group, 17 domains reached more than 70% agreement and were selected. In the second round, 10 domains were rejected, while 11 were selected to complete the pool of domains. In the third and final round, 89 items belonging to 28 domains were defined as significant to develop a WMSDs risk assessment questionnaire.
No specific risk assessment questionnaires for WMSDs were identified from the literature. WMSD risk of presence and chronicity can be defined by an assessment tool based on the biopsychosocial model and the fear-avoidance components of chronic pain. The present study provides the formulation and operationalisation of the constructs in domains and items needed for developing and validating the questionnaire.
In oncology and palliative care, patient question prompt lists (QPLs) with sample questions for patient and family increased patients’ involvement in decision-making and improved outcomes if physicians actively endorsed asking questions. Therefore, we aim to evaluate practitioners’ perceptions of acceptability and possible use of a QPL about palliative and end-of-life care in dementia.
Mixed-methods evaluation study of a QPL developed with family caregivers and experts comprising a survey and interviews with practitioners.
Two academic medical training centres for primary and long-term care in the Netherlands.
Practitioners (n=66; 73% woman; mean of 21 (SD 11) years of experience) who were mostly general practitioners and elderly care physicians.
The main survey outcome was acceptability measured with a 15–75 acceptability scale with ≥45 meaning ‘acceptable’.
The survey response rate was 21% (66 of 320 participated). The QPL was regarded as acceptable (mean 51, SD 10) but 64% felt it was too long. Thirty-five per cent would want training to be able to answer the questions. Those who felt unable to answer (31%) found the QPL less acceptable (mean 46 vs 54 for others; p=0.015). We identified three themes from nine interviews: (1) enhancing conversations through discussing difficult topics, (2) proactively engaging in end-of-life conversations and (3) possible implementation.
Acceptability of the QPL was adequate, but physicians feeling confident to be able to address questions about end-of-life care is crucial when implementing it in practice, and may require training. To facilitate discussions of advance care planning and palliative care, families and persons with dementia should also be empowered to access the QPL themselves.
While the uptake of value-based health care (VBHC) is remarkable, uncertainty prevails regarding the most important actions and practices in establishing a value-based healthcare system. In this paper, we generate expert consensus on the most important aspects of VBHC.
The Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system.
A Dutch expert panel consisting of nine members participated in a two-round survey.
We developed 39 initial items based on the pioneering literature on VBHC and recent health policies in the Netherlands. Experts rated the importance of each item on a 4-point Likert scale. Experts could change items or add new ones as they saw fit. We retained items that were rated (very) important by ≥80% of the panel.
After two survey rounds, 32 items (72%) were included through expert consensus. Experts unanimously agree on the importance of shared decision-making, with this item uniquely obtaining the maximum score. Experts also reached consensus on the importance of outcome measurements, a focus on medical conditions, and full cycles of care. No consensus was reached on the importance of benchmarking.
This paper provides new insight into the most important actions and practices for establishing a value-based healthcare system in the Netherlands. Interestingly, several of our findings contrast with the pioneering literature on VBHC. This raises the question whether VBHC’s widespread international uptake indicates its actual implementation, or rather that the original concept primarily serves as an inspiring idea.
Using patient-reported outcome measures (PROMs) with children have been described as ‘giving a voice to the child’. Few studies have examined the routine use of these measures as potentially therapeutic interventions. This study aims to investigate: (1) the effectiveness of feedback using graphical displays of information from electronic PROMs (ePROMs) that target health-related quality of life, to improve health outcomes, referrals and treatment satisfaction and (2) the implementation of ePROMs and graphical displays by assessing acceptability, sustainability, cost, fidelity and context of the intervention and study processes.
A hybrid II effectiveness-implementation study will be conducted from February 2020 with children with life-altering skin conditions attending two outpatient clinics at a specialist paediatric children’s hospital. A pragmatic randomised controlled trial and mixed methods process evaluation will be completed. Randomisation will occur at the child participant level. Children or parent proxies completing baseline ePROMs will be randomised to: (1) completion of ePROMs plus graphical displays of ePROM results to treating clinicians in consultations, versus (2) completion of ePROMs without graphical display of ePROM results. The primary outcome of the effectiveness trial will be overall health-related quality of life of children. Secondary outcomes will include other health-related quality of life outcomes (eg, child psychosocial and physical health, parent psychosocial health), referrals and treatment satisfaction. Trial data will be primarily analysed using linear mixed-effects models; and implementation data using inductive thematic analysis of interviews, meeting minutes, observational field notes and study communication mapped to the Consolidated Framework for Implementation Research.
Ethical approval was obtained from Children’s Health Queensland Human Research Ethics Committee (HREC/2019/QCHQ/56290), The University of Queensland (2019002233) and Queensland University of Technology (1900000847). Dissemination will occur through stakeholder groups, scientific meetings and peer-reviewed publications.
Australian New Zealand Clinical Trials Registry (ACTRN12620000174987).
This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS).
This is a randomised, blinded controlled trial involving patients diagnosed with ALS, both sexes, age between 18 and 80 years. Patients will be randomly allocated into the conventional respiratory care (CRC) group and the optimised respiratory care home-based (ORC) group. Primary outcomes will be peak cough flow, the number of exacerbations and ALS Functional Rating Scale Revised. Secondary outcomes will include chest wall volumes, maximal respiratory pressures, sniff nasal inspiratory pressure, nasal expiratory pressure and forced vital capacity (FVC), forced expiratory volume in the 1st second (FEV1) and FEV1/FVC. The CRC group will receive educational information about respiratory care at the clinic. The ORC group will receive conventional care and home-based care. The clinical status of all individuals will be monitored weekly through telephone calls. A 6-month intervention is planned, the outcomes will be assessed every 3 months and 3 and 6 months follow-up after final evaluation. The primary and secondary results will be described as average or median for continuous variables and absolute and relative frequencies for qualitative variables. Treatment effects or differences between the outcomes (baseline, 3 months and 6 months) of the study groups will be analysed using an analysis of variance. The level of significance will be set as p≤0.05.
The research ethics committee approved the study. It is expected to evaluate respiratory function in patients with ALS in the short, medium and long terms with home-based care protocol applied. The disease’s rapid progression is a limitation for performing a long-term clinical study.
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.
To develop a model of in-hospital mortality using medical record front page (MRFP) data and assess its validity in case-mix standardisation by comparison with a model developed using the complete medical record data.
A nationally representative retrospective study.
Representative hospitals in China, covering 161 hospitals in modelling cohort and 156 hospitals in validation cohort.
Representative patients admitted for acute myocardial infarction. 8370 patients in modelling cohort and 9704 patients in validation cohort.
In-hospital mortality, which was defined explicitly as death that occurred during hospitalisation, and the hospital-level risk standardised mortality rate (RSMR).
A total of 14 variables were included in the model predicting in-hospital mortality based on MRFP data, with the area under receiver operating characteristic curve of 0.78 among modelling cohort and 0.79 among validation cohort. The median of absolute difference between the hospital RSMR predicted by hierarchical generalised linear models established based on MRFP data and complete medical record data, which was built as ‘reference model’, was 0.08% (10th and 90th percentiles: –1.8% and 1.6%). In the regression model comparing the RSMR between two models, the slope and intercept of the regression equation is 0.90 and 0.007 in modelling cohort, while 0.85 and 0.010 in validation cohort, which indicated that the evaluation capability from two models were very similar.
The models based on MRFP data showed good discrimination and calibration capability, as well as similar risk prediction effect in comparison with the model based on complete medical record data, which proved that MRFP data could be suitable for risk adjustment in hospital performance measurement.
The aim was to use routine data available at a patient’s admission to the hospital to predict polypharmacy and drug–drug interactions (DDI) and to evaluate the prediction performance with regard to its usefulness to support the efficient management of benefits and risks of drug prescriptions.
Retrospective, longitudinal study.
We used data from a large multicentred pharmacovigilance project carried out in eight psychiatric hospitals in Hesse, Germany.
Inpatient episodes consecutively discharged between 1 October 2017 and 30 September 2018 (year 1) or 1 January 2019 and 31 December 2019 (year 2).
The proportion of rightly classified hospital episodes.
We used gradient boosting to predict respective outcomes. We tested the performance of our final models in unseen patients from another calendar year and separated the study sites used for training from the study sites used for performance testing.
A total of 53 909 episodes were included in the study. The models’ performance, as measured by the area under the receiver operating characteristic, was ‘excellent’ (0.83) and ‘acceptable’ (0.72) compared with common benchmarks for the prediction of polypharmacy and DDI, respectively. Both models were substantially better than a naive prediction based solely on basic diagnostic grouping.
This study has shown that polypharmacy and DDI can be predicted from routine data at patient admission. These predictions could support an efficient management of benefits and risks of hospital prescriptions, for instance by including pharmaceutical supervision early after admission for patients at risk before pharmacological treatment is established.
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.
Robust research of complex interventions designed to promote mental well-being in later life is required to inform service development. An essential component is ensuring that such interventions are delivered as intended. We present a detailed description of the design and implementation of a fidelity assessment within a trial of one such intervention (Lifestyle Matters). The findings help to explain the trial results and also inform the design of embedded fidelity assessments within future evaluations of complex interventions.
We conducted a mixed-method fidelity assessment embedded as part of a multicentre pragmatic randomised controlled trial. A conceptual fidelity framework was developed from the Behaviour Change Consortium framework. From this the fidelity assessment was designed. The resulting instrument assessed the following parameters: intervention design, training, supervision; and delivery, receipt and enactment of the intervention.
The Lifestyle Matters intervention was designed to assist older people to improve and sustain mental well-being through participation in meaningful activity. The aim is to enable participants to engage in both new and neglected activities through a mix of facilitated group meetings and individual sessions.
The fidelity assessment demonstrated that the intervention was delivered as per protocol for the group component and was tailored to meet individual needs. There was substantial inter-rater agreement for training; and group member performance 0.72; and moderate agreement for facilitator performance 0.55. It was not possible to determine whether small declines seen in facilitator performance were due to facilitator drift or moderating factors such as group dynamics or participant characteristics.
The assessment methods adequately measured criteria identified as being significant indicators of fidelity. Adherence during training, delivery and supervision was good. The subjective nature of identification and rating observed behaviours was the main challenge. Future research should explore alternative methods of assessing fidelity in trials of complex interventions.
Fetal growth restriction, preterm birth, low birth weight and stillbirth are adverse birth outcomes that are prevalent in low-income and middle-income settings such as the Pacific Island region. It is widely accepted that the excess burden of adverse birth outcomes is attributable to socioeconomic and environmental factors that predispose families to excess risk. Our review seeks to determine the prevalence of adverse birth outcomes in the Pacific Island region and to identify the risk factors of adverse birth outcomes in the Pacific Island region.
This scoping review will follow the five-staged Arksey and O’Malley’s framework and consultation with Solomon Islands’ health stakeholders. A preliminary literature review was undertaken to understand the scope of the review. We will use Medical Subject Heading and keyword terms for adverse birth outcomes to search CINAHL, Medline, Scopus, ProQuest and Springer Link databases for articles published from 1 January 2000. The subsequent searches will be undertaken via Google Scholar and the internet browser to world health organisation and regional health organisations for published and unpublished reports on non-indexed studies. All articles retrieved will be managed with EndNote software. Eligible studies will be screened using Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart for final selection. In the charting phase, we will extract the data into Excel spreadsheets. The results will be presented as numerical and thematic summaries that map risk factors and prevalence to the population and cultures of the Pacific Island region.
Formal ethical approval is not required as primary or administrative data will not be collected. However, we will seek ethics approval for the stakeholder consultation from the Research Office of Curtin University and the Solomon Islands. The findings of this study will be published in peer-reviewed journals and presented in national and regional conferences and disseminated to stakeholders.
There will be no direct contact with human or patients in the case of the scoping review; therefore, no ethics will be required. However, we will seek ethical approval from the Research Ethics Office of Curtin University and the Health Research and Ethics Committee in the Solomon Islands for stakeholder consultation. Dissemination will be made through regional conferences and publication in peer-reviewed journals.
At a time of unprecedented attention to the public health impact of policing, it is imperative to understand the role of occupational safety in shaping officer behaviours. We assessed the longitudinal impact of police training in a quasi-experimental hybrid type-1 trial to reduce syringe-related occupational risk, while realigning police practices with public health prevention among people who inject drugs (PWID).
Of 1806 Tijuana municipal police trainees, 771 reporting previous exposure to syringes were randomly selected for follow-up. All participants completed at least one follow-up visit; attrition at 24 months was 8%.
Between 2015 and 2016, officers received a training intervention (Safety and Health Integration in the Enforcement of Laws on Drugs, SHIELD) bundling occupational needle stick injury (NSI) prevention with health promotion among PWID.
Longitudinal analysis with generalised linear mixed models to evaluate training impact on occupational NSI risk via NSI incidence and prevalidated Syringe Threat and Injury Correlates (STIC) score. This composite indicator integrates five self-reported risky syringe-handling practices (eg, syringe confiscation, breaking) and was used as a proxy for NSI risk due to reporting bias and concerns about reliability of NSI incidence reports.
No change in self-reported NSI incidence was observed, but significant reductions in risk (16.2% decrease in STIC score) occurred at 3 months, with a sustained decrease of 17.8% through 24 months, compared with pretraining (p
SHIELD is the first intervention to be associated with significant sustained changes in police practices that pose risk for both occupational and the public’s health. Integrating occupational safety and public health education should inform other interventions to mitigate the community health detriments of policing behaviours.
Undertake a scoping review to determine the effectiveness of community-centred interventions designed to improve the mental health and well-being of adults from ethnic minority groups in the UK.
We searched six electronic academic databases for studies published between January 1990 and September 2019: Medline, Embase, PsychINFO, Scopus, CINAHL and Cochrane. For intervention description and data extraction we used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews checklist and Template for Intervention Description and Replication guide. Quality was assessed using Cochrane risk of bias tools. Grey literature results were deemed beyond the scope of this review due to the large number of interventions and lack of available outcomes data.
Of 4501 studies, 7 met the eligibility criteria of UK-based community interventions targeting mental health in adults from ethnic minority populations: four randomised controlled trials, one pre/post-pilot study, one cross-sectional study and one ethnographic study. Interventions included therapy-style sessions, peer-support groups, educational materials, gym access and a family services programme. Common components included a focus on tackling social isolation, using lay health workers from within the community, signposting and overcoming structural barriers to access. Four studies reported a statistically significant positive effect on mental health outcomes and six were appraised as having a high risk of bias. Study populations were ethnically heterogeneous and targeted people mainly from South Asia. No studies examined interventions targeting men.
There is a paucity of high-quality evidence regarding community-centred interventions focused on improving public mental health among ethnic minority groups. Decision makers need scientific evidence to inform effective approaches to mitigating health disparities. Our next steps are to map promising community activities and interventions that are currently being provided to help identify emerging evidence.
Spin is defined as reporting practices that distort the interpretation of results and create misleading conclusions by suggesting more favourable results. Such unjustifiable and misleading misrepresentation may negatively influence the development of further studies, clinical practice and healthcare policies. Spin manifests in various patterns in different sections of publications (titles, abstracts and main texts). The primary aim of this study is to identify reported spin patterns and assess the prevalence of spin in general, and the prevalence of spin patterns reported in biomedical literature based on previously published systematic reviews and literature reviews on spin.
PubMed, EMBASE and SCOPUS will be searched to identify systematic or literature reviews on spin in biomedicine. To improve the comprehensiveness of the search, the snowballing method will be used to broaden the search. The data on spin-related outcomes and characteristics of the included studies will be extracted. The methodological quality of the included studies will be assessed with selective items of the A MeaSurement Tool to Assess systematic Reviews-2 checklist. A new classification scheme for spin patterns will be developed if the classifications of spin patterns identified in the included studies vary. The prevalence of spin and spin patterns will be pooled based on meta-analyses if the classification schemes for spin are comparable across included studies. Otherwise, the prevalence will be described qualitatively. The seriousness of spin patterns will be assessed based on a Delphi consensus study.
This study has been approved by the Academic Centre for Dentistry Amsterdam Ethics Review Committee (2020250). The study will be submitted to a peer-reviewed scientific journal.
Open Science Framework: osf.io/hzv6e
In low-income and middle-income countries, pneumonia remains the leading cause of illness and death in children
Approximately 10 000 paediatric chest X-ray images are currently being collected from an ongoing WHO-supported surveillance study in Bangladesh. Each image will be read by two trained clinicians/radiologists for the presence or absence of primary endpoint pneumonia (PEP) in each lung, as defined by the WHO. Images whose PEP labels are discordant in either lung will be reviewed by a third specialist and the final assignment will be made using a majority vote. Convolutional neural networks will be used for lung segmentation to align and scale the images to a reference, and for interpretation of the images for the presence of PEP. The model will be evaluated against an independently collected and labelled set of images from the WHO. The study outcome will be an automated method for the interpretation of chest radiographs for diagnosing paediatric pneumonia.
All study protocols were approved by the Ethical Review Committees of the Bangladesh Institute of Child Health, Bangladesh. The study sponsor deemed it unnecessary to attain ethical approval from the Academic and Clinical Central Office for Research and Development of University of Edinburgh, UK. The study uses existing X-ray images from an ongoing WHO-coordinated surveillance. All findings will be published in an open-access journal. All X-ray labels and statistical code will be made openly available. The model and images will be made available on request.
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.