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Multivariate analysis of the impact of weather and air pollution on emergency department visits for night-time headaches among children: retrospective, clinical observational study

Por: Yamaguchi · H. · Nozu · K. · Ishiko · S. · Nagase · H. · Ninchoji · T. · Nagano · C. · Takeda · H. · Unzaki · A. · Ishibashi · K. · Morioka · I. · Iijima · K. · Ishida · A.
Objectives

To examine the association between the number of visits to the emergency department (ED) by children for night-time headaches and exposure to multifaceted factors, such as meteorological conditions and air pollution.

Design

We conducted a clinical observational time-series analysis study.

Setting

We reviewed consecutive patients younger than 16 years of age at the primary ED centre in Kobe city, Japan, during the night shift (19:30–7:00 hours) between 1 January 2011 and 31 December 2019.

Participants

In total, 265 191 children visited the ED; 822 presented with headache during the study period.

Primary outcome measures

We investigated the effects of meteorological factors and air pollutants by multivariate analysis of Poisson regression estimates. A subanalysis included the relationship between the number of patients with night-time headaches and the above factors by sex. Furthermore, the effect of typhoon landing on patient visits for headache was also analysed. Headache was not classified because examinations were performed by general paediatricians (non-specialists).

Results

The number of patients with night-time headaches displayed distinct seasonal changes, with peaks during the summer. Multivariate analysis of Poisson regression estimates revealed a significant positive relationship between the number of patients for headache and mean temperature. Subanalysis by sex indicated a positive relationship between the number of patients with headache and mean temperature in both sexes; however, it was significant only for females. No relationship was found between the number of patients with headache and air pollution. There was no change in the number of patients for night-time headaches 3 days before and after typhoon landing.

Conclusions

High temperature is the main factor for visiting ED for night-time headaches among children in Kobe city. Our results suggest that preventive measures against night-time headaches may be possible by reducing time spent outside during summer.

Development of a core outcome set for congenital pulmonary airway malformations: study protocol of an international Delphi survey

Por: Hermelijn · S. · Kersten · C. · Mullassery · D. · Muthialu · N. · Cobanoglu · N. · Gartner · S. · Bagolan · P. · Mesas Burgos · C. · Sgro · A. · Heyman · S. · Till · H. · Suominen · J. · Schurink · M. · Desender · L. · Losty · P. · Ertresvag · K. · Tiddens · H. A. W. M. · Wijnen · R. M. H
Introduction

A worldwide lack of consensus exists on the optimal management of asymptomatic congenital pulmonary airway malformation (CPAM) even though the incidence is increasing. Either a surgical resection is performed or a wait-and-see policy is employed, depending on the treating physician. Management is largely based on expert opinion and scientific evidence is scarce. Wide variations in outcome measures are seen between studies making comparison difficult thus highlighting the lack of universal consensus in outcome measures as well. We aim to define a core outcome set which will include the most important core outcome parameters for paediatric patients with an asymptomatic CPAM.

Methods and analysis

This study will include a critical appraisal of the current literature followed by a three-stage Delphi process with two stakeholder groups. One surgical group including paediatric as well as thoracic surgeons, and a non-surgeon group including paediatric pulmonologists, intensive care and neonatal specialists. All participants will score outcome parameters according to their level of importance and the most important parameters will be determined by consensus.

Ethics and dissemination

Electronic informed consent will be obtained from all participants. Ethical approval is not required. After the core outcome set has been defined, we intend to design an international randomised controlled trial: the COllaborative Neonatal NEtwork for the first CPAM Trial, which will be aimed at determining the optimal management of patients with asymptomatic CPAM.

Expert consensus on moving towards a value-based healthcare system in the Netherlands: a Delphi study

Por: Steinmann · G. · Delnoij · D. · van de Bovenkamp · H. · Groote · R. · Ahaus · K.
Objectives

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.

Design

The Delphi technique was used to reach consensus on the most important practices in moving towards a value-based healthcare system.

Setting and participants

A Dutch expert panel consisting of nine members participated in a two-round survey.

Primary and secondary outcome measures

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.

Results

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.

Conclusion

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.

Team‐based learning in nursing education: A scoping review

Abstract

Aims and objectives

To explore the use and student outcomes of Team‐Based Learning in nursing education.

Background

Team‐Based Learning is a highly structured, evidence‐based, student‐centred learning strategy that enhances student engagement and facilitates deep learning in a variety of disciplines including nursing. However, the breadth of Team‐Based Learning application in nursing education and relevant outcomes are not currently well understood.

Design

A scoping review of international, peer‐reviewed research studies was undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses extension for scoping reviews.

Methods

The following databases were searched on 7 May 2020: Cumulative Index of Nursing and Allied Health Literature, MEDLINE Complete, PsycINFO and Education Resources Information Center. Search terms related to nursing, education and Team‐Based Learning. Original research studies, published in English, and reporting on student outcomes from Team‐Based Learning in nursing education programmes were included.

Results

Of the 1081 potentially relevant citations, 41 studies from undergraduate (n = 29), postgraduate (n = 4) and hospital (n = 8) settings were included. The most commonly reported student outcomes were knowledge or academic performance (n = 21); student experience, satisfaction or perceptions of Team‐Based Learning (n = 20); student engagement with behaviours or attitudes towards Team‐Based Learning (n = 12); and effect of Team‐Based Learning on teamwork, team performance or collective efficacy (n = 6). Only three studies reported clinical outcomes.

Conclusions

Over the last decade, there has been a growing body of knowledge related to the use of Team‐Based Learning in nursing education. The major gaps identified in this scoping review were the lack of randomised controlled trials and the dearth of studies of Team‐Based Learning in postgraduate and hospital contexts.

Relevance to clinical practice

This scoping review provides a comprehensive understanding of the use and student outcomes of Team‐Based Learning in nursing education and highlights the breadth of application of Team‐Based Learning and variability in the outcomes reported.

Effects of an optimised approach to home-based respiratory care in individuals with amyotrophic lateral sclerosis: a study protocol for a randomised controlled trial

Por: Pondofe · K. · Fregonezi · G. A. F. · Brito · O. · Dourado Junior · M. E. · Torres-Castro · R. · Resqueti · V. R.
Introduction

This study aims to investigate the effects of an optimal home-based respiratory care protocol in individuals with amyotrophic lateral sclerosis (ALS).

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

RBR-3z23ts; Pre-results.

Travel-related control measures to contain the COVID-19 pandemic: an evidence map

Por: Movsisyan · A. · Burns · J. · Biallas · R. · Coenen · M. · Geffert · K. · Horstick · O. · Klerings · I. · Pfadenhauer · L. M. · von Philipsborn · P. · Sell · K. · Strahwald · B. · Stratil · J. M. · Voss · S. · Rehfuess · E.
Objectives

To comprehensively map the existing evidence assessing the impact of travel-related control measures for containment of the SARS-CoV-2/COVID-19 pandemic.

Design

Rapid evidence map.

Data sources

MEDLINE, Embase and Web of Science, and COVID-19 specific databases offered by the US Centers for Disease Control and Prevention and the WHO.

Eligibility criteria

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.

Data extraction and synthesis

We extracted data from included studies in a standardised manner and mapped them to a priori and (one) post hoc defined categories.

Results

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.

Conclusions

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.

CopenFast trial: Faster-acting insulin Fiasp versus insulin NovoRapid in the treatment of women with type 1 or type 2 diabetes during pregnancy and lactation - a randomised controlled trial

Por: Norgaard · S. K. · Mathiesen · E. R. · Norgaard · K. · Clausen · T. D. · Damm · P. · Ringholm · L.
Introduction

Faster-acting insulin aspart (Fiasp) is approved for use in pregnancy and lactation, but no clinical study has evaluated its effects during this life stage in women with pre-existing diabetes. The aim of the CopenFast trial is to evaluate the effect of Fiasp compared with insulin aspart (NovoRapid) on maternal glycaemic control during pregnancy, delivery and lactation and on fetal growth and infant health.

Methods and analysis

An open-label randomised controlled trial of pregnant women with type 1 or type 2 diabetes including women on multiple daily injection (MDI) therapy or insulin pump therapy. During a 2-year inclusion period, approximately 220 women will be randomised 1:1 to Fiasp or NovoRapid in early pregnancy and followed until 3 months after delivery. At 9, 21 and 33 gestational weeks and during planned induction of labour or caesarean section, women are offered blinded continuous glucose monitoring (CGM) for 7 days. Randomisation will stratify for type of diabetes and insulin treatment modality (MDI or insulin pump therapy, respectively). Health status of the infants will be followed until 3 months of age. The primary outcome is birth weight SD score adjusted for gestational age and gender. Secondary outcomes include maternal glycaemic control including glycated haemoglobin, preprandial and postprandial self-monitored plasma glucose levels, episodes of mild and severe hypoglycaemia, maternal gestational weight gain and weight retention, CGM time spent in, above and below target ranges as well as pregnancy outcomes including pre-eclampsia, preterm delivery, perinatal mortality and neonatal morbidity. Data analysis will be performed according to the intention-to-treat principle.

Ethics and dissemination

The trial has been approved by the Regional Ethics Committee (H-19029966) on 7 August 2019. Results will be sought disseminated in peer-reviewed journals and at scientific meetings.

Trial registration number

NCT03770767

Predicting the risk of drug-drug interactions in psychiatric hospitals: a retrospective longitudinal pharmacovigilance study

Por: Wolff · J. · Hefner · G. · Normann · C. · Kaier · K. · Binder · H. · Domschke · K. · Hiemke · C. · Marschollek · M. · Klimke · A.
Objectives

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.

Design

Retrospective, longitudinal study.

Setting

We used data from a large multicentred pharmacovigilance project carried out in eight psychiatric hospitals in Hesse, Germany.

Participants

Inpatient episodes consecutively discharged between 1 October 2017 and 30 September 2018 (year 1) or 1 January 2019 and 31 December 2019 (year 2).

Outcome measures

The proportion of rightly classified hospital episodes.

Methods

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.

Results

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.

Conclusion

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.

Factors associated with mobile phone usage to access maternal and child healthcare among women of urban slums in Dhaka, Bangladesh: a cross-sectional study

Por: Mistry · S. K. · Akter · F. · Yadav · U. N. · Hossain · M. B. · Sichel · A. · Labrique · A. B. · Storisteanu · D. M. L.
Introduction

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.

Methods

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.

Results

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.

Conclusion

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.

Study protocol for You.Mind!: boosting first-line mental health care for YOUngsters suffering from chronic conditions with mindfulness: a randomised staggered within-subjects design

Por: Kock · M. · Van Hoecke · E. · Raes · F. · Van der Gucht · K.
Introduction

Adolescents with chronic conditions often experience high levels of stress, anxiety and depression, and reduced quality of life. Mindfulness-based interventions (MBIs) have been found to improve emotional distress in clinical and non-clinical populations and are a promising technique to support adolescents with chronic conditions in managing their symptoms and ultimately enhance their quality of life.

Methods and analysis

To test the effects of an MBI on emotional distress and quality of life and delineate the underlying mechanisms, the You.Mind! study uses a randomised staggered within-subjects design. Thirty adolescents with a chronic condition will be randomised to a baseline phase of 14–28 days followed by an MBI, consisting of four online group sessions and online support spread over 8 weeks. Outcomes will be assessed by short, repeated measurements throughout the baseline, intervention and follow-up phases and by standardised questionnaires and experience sampling measures before randomisation, at postintervention and at 3-months follow-up. Analysis will be based on general linear modelling and multilevel mixed-effects modelling.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee Research UZ/KU Leuven and the Ethics Committee of Ghent University Hospital and Ghent University (S63485). Results will be disseminated through presentations at public lectures, scientific institutions and meetings, and through publication in peer-reviewed journals.

Trial registration number

NCT04359563.

Investigation of hypertensive arteriopathy-related and cerebral amyloid angiopathy-related small vessel disease scores in patients from a memory clinic: a prospective single-centre study

Por: Matsuda · K. · Shindo · A. · Ii · Y. · Tabei · K.-i. · Ueda · Y. · Ishikawa · H. · Matsuura · K. · Yoshimaru · K. · Taniguchi · A. · Kato · N. · Satoh · M. · Maeda · M. · Tomimoto · H.
Objective

The severity of cerebral small vessel disease (SVD) is assessed through neuroimaging findings, including hypertensive arteriopathy (HA)-SVD and cerebral amyloid angiopathy (CAA)-SVD. HA-SVD and CAA-SVD have been collectively estimated as total scores: the HA-SVD and CAA-SVD scores, respectively. Previous reports suggest that HA-SVD scores are associated with cognitive function; however, the relationship between CAA-SVD scores and cognitive function remains unclear. Therefore, we examined the association between CAA-SVD scores and cognitive function. Furthermore, we developed a modified CAA-SVD score considering cortical microinfarcts and posterior dominant white matter hyperintensities, which are imaging findings of CAA, and examined the association between these scores and cognitive function in the same patient group.

Design

Prospective study.

Setting

Single centre study from a memory clinic.

Participants

Subjects were diagnosed with mild cognitive impairment (MCI) or mild dementia in our memory clinic between February 2017 and July 2019 and underwent clinical dementia rating scale and brain MRI assessment. A total of 42 patients (aged 75.3±9.12 years) were registered prospectively.

Primary and secondary outcome measures

We evaluated intellectual function, memory, frontal lobe function and constructional ability. Furthermore, the relationship between each score and cognitive function was examined.

Results

The CAA-SVD score showed significant associations with cognitive function (R2=0.63, p=0.016), but the HA-SVD score did not (R2=0.41, p=0.35). The modified CAA-SVD score was also significantly associated with cognitive function (R2=0.65, p=0.008).

Conclusion

Cognitive function is associated with the CAA-SVD score, and more efficiently with the modified CAA-SVD score, in memory clinic patients. Although we have not validated the weighting of the modified CAA-SVD score, these scores can be a predictor of cognitive deterioration in patients with MCI and mild dementia.

Treatment preferences for preventive interventions for rheumatoid arthritis: protocol of a mixed methods case study for the Innovative Medicines Initiative PREFER project

Por: Falahee · M. · Simons · G. · DiSantostefano · R. L. · Valor Mendez · L. · Radawski · C. · Englbrecht · M. · Schölin Bywall · K. · Tcherny-Lessenot · S. · Kihlbom · U. · Hauber · B. · Veldwijk · J. · Raza · K.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Web-based early intervention for children with motor difficulties aged 3-8 years old using multimodal rehabilitation (WECARE): protocol of a patient-centred pragmatic randomised trial of paediatric telerehabilitation to support families

Por: Camden · C. · Zwicker · J. G. · Morin · M. · Schuster · T. · Couture · M. · Poder · T. G. · Maltais · D. B. · Battista · M.-C. · Baillargeon · J.-P. · Goyette · M. · Pratte · G. · Hurtubise · K. · Phoenix · M. · Nguyen · T. · Berbari · J. · Tousignant · M. · WECARE TEAM
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT04254302.

Predictors of poor health and functional recovery following road trauma: protocol of a British Columbian inception cohort study

Por: Shum · L. K. · Chan · H. · Erdelyi · S. · Pei · L. X. · Brubacher · J. R.
Introduction

Road trauma (RT) is a major public health problem affecting physical and mental health, and may result in prolonged absenteeism from work or study. It is important for healthcare providers to know which RT survivors are at risk of a poor outcome, and policy-makers should know the associated costs. Unfortunately, outcome after RT is poorly understood, especially for RT survivors who are treated and released from an emergency department (ED) without the need for hospital admission. Currently, there is almost no research on risk factors for a poor outcome among RT survivors. This study will use current Canadian data to address these knowledge gaps.

Methods and analysis

We will follow an inception cohort of 1500 RT survivors (16 years and older) who visited a participating ED within 24 hours of the accident. Baseline interviews determine pre-existing health and functional status, and other potential risk factors for a poor outcome. Follow-up interviews at 2, 4, 6, and 12 months (key stages of recovery) use standardised health-related quality of life tools to determine physical and mental health outcome, functional recovery, and healthcare resource use and lost productivity costs.

Ethics and dissemination

The Road Trauma Outcome Study is approved by our institutional Research Ethics Board. This study aims to provide healthcare providers with knowledge on how quickly RT survivors recover from their injuries and who may be more likely to have a poor outcome. We anticipate that this information will be used to improve management of all road users following RT. Healthcare resource use and lost productivity costs will be collected to provide a better cost estimate of the effects of RT. This information can be used by policy-makers to make informed decisions on RT prevention programmes.

Clinical characteristics of hospitalised patients with COVID-19 and the impact on mortality: a single-network, retrospective cohort study from Pennsylvania state

Por: Gadhiya · K. P. · Hansrivijit · P. · Gangireddy · M. · Goldman · J. D.
Objective

COVID-19 is a respiratory disease caused by SARS-CoV-2 with the highest burden in the USA. Data on clinical characteristics of patients with COVID-19 in US population are limited. Thus, we aim to determine the clinical characteristics and risk factors for in-hospital mortality from COVID-19.

Design

Retrospective observational study.

Setting

Single-network hospitals in Pennsylvania state.

Participants

Patients with confirmed SARS-CoV-2 infection who were hospitalised from 1 March to 31 May 2020.

Primary and secondary outcome measures

Primary outcome was in-hospital mortality. Secondary outcomes were complications, such as acute kidney injury (AKI) and acute respiratory distress syndrome (ARDS).

Results

Of 283 patients, 19.4% were non-survivors. The mean age of all patients was 64.1±15.9 years. 56.2% were male and 50.2% were white. Several factors were identified from our adjusted multivariate analyses to be associated with in-hospital mortality: increasing age (per 1-year increment; OR 1.07 (1.045 to 1.105)), hypoxia (oxygen saturation 10 109/µL; OR 2.732 (1.412 to 5.263)), ferritin >336 ng/mL (OR 4.016 (1.195 to 13.514)), lactate dehydrogenase >200 U/L (OR 7.752 (1.639 to 37.037)), procalcitonin >0.25 ng/mL (OR 2.404 (1.011 to 5.714)), troponin I >0.03 ng/mL (OR 2.242 (1.080 to 4.673)), need for advanced oxygen support other than simple nasal cannula (OR 4.608–13.889 (2.053 to 31.250)), intensive care unit admission/transfer (OR 13.699 (6.135 to 30.303)), renal replacement therapy (OR 21.277 (5.025 to 90.909)), need for vasopressor (OR 22.222 (9.434 to 52.632)), ARDS (OR 23.810 (10.204 to 55.556)), respiratory acidosis (OR 7.042 (2.915 to 16.949)), and AKI (OR 3.571 (1.715 to 7.407)). When critically ill patients were analysed independently, increasing Sequential Organ Failure Assessment score (OR 1.544 (1.168 to 2.039)), AKI (OR 2.128 (1.111 to 6.667)) and ARDS (OR 6.410 (2.237 to 18.182)) were predictive of in-hospital mortality.

Conclusion

We reported the characteristics of ethnically diverse, hospitalised patients with COVID-19 from Pennsylvania state.

Evaluation of intervention fidelity of a complex psychosocial intervention Lifestyle Matters: a randomised controlled trial

Por: Sprange · K. · Mountain · G. · Craig · C.
Objectives

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.

Design

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.

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.

Results

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.

Conclusions

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.

Trial registration number

ISRCTN67209155.

Using a behavioural approach to explore the factors that affect questionnaire return within a clinical trial: a qualitative study based on the theoretical domains framework

Por: Lawrie · L. · Duncan · E. M. · Dunsmore · J. · Newlands · R. · Gillies · K.
Objectives

To identify barriers and enablers to participant retention in trials requiring questionnaire return using the theoretical domains framework (TDF).

Study design and setting

We identified and subsequently invited participants who did not return at least one questionnaire during their participation in a clinical trial for one-to-one semi-structured telephone interviews. We used a behavioural framework (TDF) to explore whether any of the behavioural domains (eg, beliefs about consequences, emotion) affected questionnaire return. Thereafter, we generated a series of belief statements which summarised the content of participants’ main responses and coded these under separate themes.

Participants

We distributed invites to 279 eligible individuals and subsequently interviewed 9 participants who took part in the C-Gall trial. The C-Gall trial required participants to complete five postal questionnaires during their participation.

Results

Nine participants were interviewed. We developed 7 overarching themes which were relevant for returning postal questionnaires and identified both barriers and enablers from 11 core domains: knowledge; beliefs about consequences; environmental context and resources; reinforcement; emotion; beliefs about capabilities; behavioural regulation; social professional role and identity; skills; intentions and goals. Relevant content coded under these salient domains were categorised into seven key themes: unclear expectations of trial participation, personal attributes for questionnaire return, commitment to returning questionnaires given other priorities, sources of support in returning the questionnaires, individual preferences for presentation mode and timing of the questionnaires, internal and external strategies to encourage questionnaire return and the significance of questionnaire non-return.

Conclusion

We demonstrate how a behavioural approach may be useful for clinical trials associated with significant participation burden (e.g. trials that require multiple questionnaire responses), acting as the essential groundwork for the development of appropriate evidence-based solutions to combat retention issues.

Trial registration number

55215960; Pre-results.

Does mothers pregnancy intention affect their childrens preventive and curative care in India? Evidence from a longitudinal survey

Por: Chowdhury · P. · Garg · M. K. · Kanchan Sk · M. I.
Objective

To assess the effect of unintended births on preventive and curative care of children and their nutritional status.

Design

The study uses a cross-sectional prospective design.

Setting

Indian Human Development Survey (IHDS) data of two rounds were used in this study. Women data file was used to draw a representative sample of 3905 children who belong to under 5 years of age group.

Statistical analyses

We categorised birth as an unintended birth if the mother did not want to have an additional child at IHDS-I but gave birth during the intersurvey. Furthermore, all births exceeding to the desired number of children reported by mothers in the IHDS-II were also included in unintended births. Multivariate logistic regression models were applied to analyse the effect of unintended births on child immunisation and exclusive breast feeding, while multivariate linear regression models were used to assess the effect of childbearing intention on child nutritional status.

Results

The study shows that by controlling other factors, children from unintended births were less likely to be exclusively breast fed (OR 0.885, 95% CI 0.792 to 0.990, p

Conclusions

The study confirmed the adverse effects of unintended pregnancy on children’s preventive and curative care. The findings of the study underscore the importance of formulating policies on more affordable, accessible and available means of family planning to reduce the unintended births.

Prevalence and risk factors of adverse birth outcomes in the Pacific Island region: a scoping review protocol

Por: Kaforau · L. S. K. · Tessema · G. A. · Jancey · J. · Dhamrait · G. K. · Bugoro · H. · Pereira · G. F.
Introduction

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.

Methods

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.

Ethics and dissemination

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.

Ethics approval

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.

Epidemiological trends in COVID-19 pandemic: prospective critical appraisal of observations from six countries in Europe and the USA

Por: Velicu · M. A. · Furlanetti · L. · Jung · J. · Ashkan · K.
Introduction

Europe was the epicentre of the COVID-19 pandemic in March 2020, with the highest number of cases and deaths between March and April. In May, the infection numbers registered a fall followed by a second new rise, not proportionally reflected by an increase in the number of deaths. We aimed to investigate the relationship between disease prevalence and infection fatality rate (IFR), and the number of intensive care unit (ICU) and hospital admissions over time, to develop a predictive model, as well as appraising the potential contributing factors underpinning this complex relationship.

Methods

A prospective epidemiological study using data from six countries collected between 10 March and 4 September 2020. Data on the number of daily hospital and ICU admissions with COVID-19 were gathered, and the IFR and the prevalence were calculated. Trends over time were analysed. A linear regression model was used to determine the association between the fatality rates and the number of admissions.

Findings

The prediction model confirmed the linear association between the fatality rates and the numbers of ICU and hospital admissions. The exception was during the peak of the COVID-19 pandemic when the model underestimated the fatalities indicating that a substantial number of deaths occurred outside of the hospitals. The fatality rates decreased in all countries from May until September regardless of the trends in prevalence, differences in healthcare systems or strategic variations in handling the pandemic.

Interpretation

The observed gradual reduction in COVID-19 fatality rates over time despite varying disease prevalence and public health measures across multiple countries warrants search for a biological explanation. While our understanding of this novel virus grows, hospital and ICU admission rates remain effective predictors of patient outcomes which can be used as early warning signs for escalation of public health measures.

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