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1.
Hosp Pediatr ; 14(3): 163-171, 2024 Mar 01.
Article En | MEDLINE | ID: mdl-38312006

BACKGROUND: Given the lack of evidence-based guidelines for hypothermic infants, providers may be inclined to use febrile infant decision-making tools to guide management decisions. Our objective was to assess the diagnostic performance of febrile infant decision tools for identifying hypothermic infants at low risk of bacterial infection. METHODS: We conducted a secondary analysis of a retrospective cohort study of hypothermic (≤36.0 C) infants ≤90 days of age presenting to the emergency department or inpatient unit among 9 participating sites between September 1, 2016 and May 5, 2021. Well-appearing infants evaluated for bacterial infections via laboratory testing were included. Infants with complex chronic conditions or premature birth were excluded. Performance characteristics for detecting serious bacterial infection (SBI; urinary tract infection, bacteremia, bacterial meningitis) and invasive bacterial infection (IBI; bacteremia, bacterial meningitis) were calculated for each tool. RESULTS: Overall, 314 infants met the general inclusion criteria, including 14 cases of SBI (4.5%) and 7 cases of IBI (2.2%). The median age was 5 days, and 68.1% of the infants (214/314) underwent a full sepsis evaluation. The Philadelphia, Boston, IBI Score, and American Academy of Pediatrics Clinical Practice Guideline did not misclassify any SBI or IBI as low risk; however, they had low specificity and positive predictive value. Rochester and Pediatric Emergency Care Applied Research Network tools misclassified infants with bacterial infections. CONCLUSIONS: Several febrile infant decision tools were highly sensitive, minimizing missed SBIs and IBIs in hypothermic infants. However, the low specificity of these decision tools may lead to unnecessary testing, antimicrobial exposure, and hospitalization.


Bacteremia , Meningitis, Bacterial , Sepsis , Infant , Female , Pregnancy , Humans , Child , Child, Preschool , Retrospective Studies , Bacteremia/diagnosis , Boston , Fever/diagnosis , Fever/therapy , Meningitis, Bacterial/diagnosis , Meningitis, Bacterial/therapy
2.
Appetite ; 196: 107273, 2024 May 01.
Article En | MEDLINE | ID: mdl-38373535

With over 100 million humanitarian migrants globally, there is increasing pressure on high-income countries to offer resettlement opportunities. Humanitarian migrants face many challenges during pre-settlement and resettlement. One challenge is food insecurity (FI). The Building a New Life in Australia (BNLA) longitudinal cohort study gathered data from migrating units, that is, a group of humanitarian migrants included on the same visa application (n = 1599). Data were gathered in five annual waves (2013-2018). Data included food security status in four pre-settlement situations and during resettlement. The results of this secondary analysis of BNLA Wave One indicate that FI was highest in refugee camps (71%), followed by bridging visas (30%), community detention (17%), immigration detention (11%), and during early resettlement (9%). During early resettlement, respondents who were male, those from Afghanistan or Iran, and those living in a single person household reported the highest prevalence of FI. An association was found between having spent time on a bridging visa and FI during early resettlement (p < 0.01). This study's results are an important step in understanding the scale of FI and which sub-groups are most vulnerable, so the resources and policies of high-income countries can better meet food security needs during resettlement.


Refugees , Transients and Migrants , Humans , Male , Female , Longitudinal Studies , Cross-Sectional Studies , Prevalence , Australia/epidemiology , Food Insecurity
3.
Hosp Pediatr ; 14(1): e6-e12, 2024 Jan 01.
Article En | MEDLINE | ID: mdl-38062772

BACKGROUND AND OBJECTIVE: Hypothermia in young infants may be secondary to an invasive bacterial infection. No studies have explored culture time-to-positivity (TTP) in hypothermic infants. Our objective was to compare TTP of blood and cerebrospinal fluid (CSF) cultures between pathogenic and contaminant bacteria in hypothermic infants ≤90 days of age. METHODS: Secondary analysis of a retrospective cohort of 9 children's hospitals. Infants ≤90 days of age presenting to the emergency department or inpatient setting with hypothermia from September 1, 2017, to May 5, 2021, with positive blood or CSF cultures were included. Differences in continuous variables between pathogenic and contaminant organism groups were tested using a 2-sample t test and 95% confidence intervals for the mean differences reported. RESULTS: Seventy-seven infants met inclusion criteria. Seventy-one blood cultures were positive, with 20 (28.2%) treated as pathogenic organisms. Five (50%) of 10 positive CSF cultures were treated as pathogenic. The median (interquartile range [IQR]) TTP for pathogenic blood cultures was 16.8 (IQR 12.7-19.2) hours compared with 26.11 (IQR 20.5-48.1) hours for contaminant organisms (P < .001). The median TTP for pathogenic organisms on CSF cultures was 34.3 (IQR 2.0-53.7) hours, compared with 58.1 (IQR 52-72) hours for contaminant CSF organisms (P < .186). CONCLUSIONS: Our study is the first to compare the TTP of blood and CSF cultures between pathogenic and contaminant bacteria in hypothermic infants. All pathogenic bacteria in the blood grew within 36 hours. No difference in TTP of CSF cultures between pathogenic and contaminant bacteria was detected.


Bacterial Infections , Hypothermia , Infant , Child , Humans , Retrospective Studies , Hypothermia/diagnosis , Time Factors , Blood Culture
4.
BMJ Open ; 13(10): e067937, 2023 10 29.
Article En | MEDLINE | ID: mdl-37899148

INTRODUCTION: Urinary incontinence (UI) is associated with increasing age and is more frequently experienced by women. Despite 40% prevalence in the community, little is known about the prevalence/incidence of UI in older women during hospital admission. UI during hospital admissions, within this group, has also been under-researched in terms of its relationship to specific clinical conditions and mortality rates. Given that UI has serious implications for both patient care and women's general health and well-being on discharge, this protocol describes a planned research project which aims to determine mortality, morbidity, prevalence and incidence of UI in older women (≥55 years) during hospital admission to inform nursing practice. Additionally, it aims to explore the experience of nurses who deliver women's care. METHODS AND ANALYSIS: This is an explanatory mixed-methods study consisting of two phases: (1) retrospecitive analysis of electronic patient care records (EPCR) to determine prevalence/incidence of UI, clinical conditions most likely associated with UI and any associations between UI and death, (2) nurse interviews to explore views, knowledge and perceptions of performing the nursing assessment and providing care for older women (≥55 years) with UI during admission. EPCR will be gained from a National Health Service (NHS) teaching hospital. Nurse interviews will be conducted with nurses from an alternative but similar-sized NHS hospital. ETHICS AND DISSEMINATION: Ethical approval is provided by the University of Salford Ethics Committee and regulatory approval by the NHS Health Research Authority (Integrated Research Application System project ID: 303118). Local NHS trust approval to access electronic care records for the purposes of analysis of anonymised data has been provided by one of the two collaborating NHS hospitals. Findings will be disseminated through open-access geriatric or urogynaecology journals and presented to relevant stakeholders at local, national and international meetings including scientific meetings such as the UK Continence Society and International Continence Society.


Secondary Care , Urinary Incontinence , Humans , Female , Aged , Endothelial Protein C Receptor , State Medicine , Urinary Incontinence/epidemiology , Incidence
5.
Hosp Pediatr ; 13(8): 742-750, 2023 08 01.
Article En | MEDLINE | ID: mdl-37503559

BACKGROUND AND OBJECTIVES: Numerous decision tools have emerged to guide management of febrile infants, but limited data exist to guide the care of young infants presenting with hypothermia. We evaluated the variation in care for well-appearing hypothermic young infants in the hospital and/or emergency department setting between participating sites. METHODS: This is a retrospective cohort study of well-appearing infants ≤90 days old across 9 academic medical centers from September 1, 2016 to May 5, 2021. Infants were identified via billing codes for hypothermia or an initial temperature ≤36.0°C with manual chart review performed. Primary outcomes included assessment of variation in diagnostic evaluation, disposition, empirical antimicrobial therapy, and length of stay. RESULTS: Of 14 278 infants originally identified, 739 met inclusion criteria. Significant interhospital variation occurred across all primary outcomes. Across sites, a full serious bacterial illness evaluation was done in 12% to 76% of hypothermic infants. Empirical antibiotics were administered 20% to 87% of the time. Performance of herpes simplex viral testing ranged from 7% to 84%, and acyclovir was empirically started 8% to 82% of the time. Hospital admission rates ranged from 45% to 100% of patients. CONCLUSIONS: Considerable variation across multiple aspects of care exists for well-appearing young infants presenting with hypothermia. An improved understanding of hypothermic young infants and their risk of infection can lead to the development of clinical decision tools to guide appropriate evaluation and management.


Hypothermia , Humans , Infant , Anti-Bacterial Agents/therapeutic use , Hypothermia/diagnosis , Hypothermia/therapy , Retrospective Studies
6.
Womens Health (Lond) ; 19: 17455057231179061, 2023.
Article En | MEDLINE | ID: mdl-37326364

BACKGROUND: Up to 40% of older women living in the community experience urinary incontinence. In community settings, urinary incontinence impacts the quality of life, morbidity, and mortality rates. However, little is known about urinary incontinence and its impact on older women admitted to hospitals. OBJECTIVES: This scoping review aims to establish the current knowledge of urinary incontinence during hospital admission for women (⩾ 55 years of age) with three key objectives: (a) What is the prevalence/incidence of urinary incontinence? (b) What health conditions are associated with urinary incontinence? (c) Is there an association between urinary incontinence and mortality? ELIGIBILITY CRITERIA: Empirical studies were included in assessing the incidence/prevalence of urinary incontinence during hospital admissions and its related morbidities and mortality rates. Studies which only included men or younger women (< 55 years of age) were excluded. Only articles written in English and conducted between 2015 and 2021 were included. SOURCES OF EVIDENCE: A search strategy was developed, and CINAHL, MEDLINE, and Cochrane databases were searched. CHARTING METHODS: Data from each article meeting the criteria were pulled into a table, including study design, study population, and setting, aims, methods, outcome measures, and significant findings. A second researcher then reviewed the populated data extraction table. RESULTS: Overall, 383 papers were found: 7 met inclusion/exclusion criteria. Prevalence rates ranged from 22% to 80% depending on the study cohort. Several conditions were associated with urinary incontinence, including frailty, orthopaedics, stroke, palliative care, neurology, and cardiology. There was a potential positive association between mortality and urinary incontinence, although only two papers reviewed reported mortality. CONCLUSION: A dearth of literature determined the prevalence, incidence, and mortality rates for older women admitted to hospitals. Limited consensus on associated conditions was found. Further research is needed to fully explore urinary incontinence in older women during hospital admissions, particularly concerning prevalence/incidence and its association with mortality.


Quality of Life , Secondary Care , Urinary Incontinence , Aged , Female , Humans , Incidence , Prevalence , Urinary Incontinence/epidemiology , Middle Aged , Aged, 80 and over , Hospital Mortality
7.
JAMA ; 329(19): 1695-1697, 2023 05 16.
Article En | MEDLINE | ID: mdl-37010865

This study describes access to individual patient-level data from randomized clinical trials during the COVID-19 pandemic to determine whether the intent to share what was reported in the registry, publication, or preprint was consistent with actual data access.


COVID-19 , Humans , Randomized Controlled Trials as Topic , Information Dissemination
8.
J Pediatr ; 258: 113407, 2023 07.
Article En | MEDLINE | ID: mdl-37023947

OBJECTIVE: To determine the prevalence of bacteremia and meningitis (invasive bacterial infection [IBI]) in hypothermic young infants, and also to determine the prevalence of serious bacterial infections (SBI) and neonatal herpes simplex virus and to identify characteristics associated with IBI. STUDY DESIGN: We conducted a retrospective cohort study of infants ≤90 days of age who presented to 1 of 9 hospitals with historical or documented hypothermia (temperature ≤36.0°C) from September 1, 2017, to May 5, 2021. Infants were identified by billing codes or electronic medical record search of hypothermic temperatures. All charts were manually reviewed. Infants with hypothermia during birth hospitalization, and febrile infants were excluded. IBI was defined as positive blood culture and/or cerebrospinal fluid culture treated as a pathogenic organism, whereas SBI also included urinary tract infection. We used multivariable mixed-effects logistic regression to identify associations between exposure variables and IBI. RESULTS: Overall, 1098 young infants met the inclusion criteria. IBI prevalence was 2.1% (95% CI, 1.3-2.9) (bacteremia 1.8%; bacterial meningitis 0.5%). SBI prevalence was 4.4% (95% CI, 3.2-5.6), and neonatal herpes simplex virus prevalence was 1.3% (95% CI, 0.6-1.9). Significant associations were found between IBI and repeated temperature instability (OR, 4.9; 95% CI, 1.3-18.1), white blood cell count abnormalities (OR, 4.8; 95% CI, 1.8-13.1), and thrombocytopenia (OR, 5.0; 95% CI, 1.4-17.0). CONCLUSIONS: IBI prevalence in hypothermic young infants is 2.1%. Further understanding of characteristics associated with IBI can guide the development decision tools for management of hypothermic young infants.


Bacteremia , Bacterial Infections , Hypothermia , Meningitis, Bacterial , Urinary Tract Infections , Humans , Infant , Infant, Newborn , Bacteremia/complications , Bacterial Infections/epidemiology , Bacterial Infections/complications , Hypothermia/epidemiology , Meningitis, Bacterial/epidemiology , Meningitis, Bacterial/complications , Prevalence , Retrospective Studies , Urinary Tract Infections/epidemiology
9.
Hosp Pediatr ; 13(4): 308-318, 2023 04 01.
Article En | MEDLINE | ID: mdl-36974612

OBJECTIVES: To identify demographic and clinical characteristics of children with fever and/or respiratory illness associated with a diagnosis of bacterial tracheostomy-associated respiratory tract infections (bTARTI). Secondary objectives included comparison of diagnostic testing, length of stay (LOS), and readmission rates between children diagnosed with bTARTI and others. METHODS: We performed a retrospective chart review of encounters over 1 year for fever and/or respiratory illness at a single academic children's hospital for children with tracheostomy dependence. Patient characteristics, features of presenting illness, and laboratory and imaging results were collected. Generalized linear mixed models were employed to study associations between patient characteristics, diagnosis of bTARTI, and impact on LOS or readmission rates. RESULTS: Among 145 children with tracheostomies identified, 79 children contributed 208 encounters. bTARTI was diagnosed in 66 (31.7%) encounters. Significant associations with bTARTI diagnosis included chest radiograph consistent with bacterial pneumonia (odds ratio [OR], 1.77; 95% confidence interval [CI], 1.50-2.08), positive tracheal aspirate culture (OR, 1.3; 95% CI, 1.05-1.61), higher white blood cell count (16.4 vs 13.1 × 103/µ; P = .03), change in oxygen requirement (OR, 1.14; 95% CI, 1.00-1.31), telephone encounter (OR, 1.41; 95% CI, 1.09-1.81), and living at home with family (OR, 1.42; 95% CI, 1.06-1.92). LOS for admitted patients with bTARTI was 2.19 times longer (CI, 1.23-3.88). CONCLUSIONS: In our single-center study, we identified several clinical and nonclinical factors associated with a diagnosis of bTARTI. Despite widespread use, few laboratory tests were predictive of a diagnosis of bTARTI. There is need for standardization in diagnosis.


Bacterial Infections , Respiratory Tract Infections , Child , Humans , Infant , Tracheostomy/adverse effects , Retrospective Studies , Respiratory Tract Infections/diagnosis , Respiratory Tract Infections/epidemiology , Hospitalization , Length of Stay
11.
Emotion ; 23(5): 1294-1305, 2023 Aug.
Article En | MEDLINE | ID: mdl-36107656

Psychotic experiences have been associated with distortions in affective functioning, including aberrancies in affect dynamics. However, it remains unclear whether the two principal symptom dimensions of psychosis, namely paranoid ideation and hallucination spectrum experiences, are differently associated with affect dynamics, and whether associations hold after statistically controlling for depressive symptoms. We investigate this by using a novel statistical approach, the hierarchical Ornstein-Uhlenbeck (OU) process model. This is a continuous-time stochastic differential equations model in a Bayesian framework that describes dynamics in affective valence and arousal via three core parameters: attractor point, variability, and attractor strength. In a community sample with varying levels of psychotic experiences (n = 116), we measured affective valence and arousal 10 times per day for 7 days, using the experience-sampling method. We found-while statistically controlling for depressive symptoms-credible between-subjects associations between paranoid ideation and attractor points of negative valence and high arousal. We also found a credible positive association between hallucination spectrum experiences and arousal variability. Limited evidence emerged for small associations between paranoid ideation and high valence variability as well as between paranoid ideation and high attractor strengths of valence and arousal. Hallucination spectrum experiences showed some evidence for a small association with high arousal attractor points. The detailed picture of affect dynamics provided by the OU model reveals different cross-sectional affective profiles associated with paranoid ideation versus hallucination spectrum experiences that suggest different affective mechanisms of their formation and maintenance. (PsycInfo Database Record (c) 2023 APA, all rights reserved).


Paranoid Disorders , Psychotic Disorders , Humans , Paranoid Disorders/complications , Paranoid Disorders/diagnosis , Paranoid Disorders/psychology , Cross-Sectional Studies , Bayes Theorem , Psychotic Disorders/complications , Psychotic Disorders/diagnosis , Psychotic Disorders/psychology , Hallucinations/complications , Hallucinations/diagnosis , Hallucinations/psychology , Affect
12.
Ann Intern Med ; 175(9): 1305-1309, 2022 09.
Article En | MEDLINE | ID: mdl-35914264

DESCRIPTION: The Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient advocacy representatives, developed a recommendation for counseling midlife women aged 40 to 60 years with normal or overweight body mass index (BMI; 18.5 to 29.9 kg/m2) to maintain weight or limit weight gain to prevent obesity with the long-term goals of optimizing health, function, and well-being. This recommendation is intended to guide clinical practice and coverage of clinical preventive health services for the Health Resources and Services Administration and other stakeholders. Clinicians providing preventive health care to women in primary care settings are the target audience for this recommendation. METHODS: The WPSI developed this recommendation after evaluating results of a systematic review of the effectiveness and harms of interventions to prevent weight gain and obesity in women aged 40 to 60 years without obesity. Seven randomized clinical trials including 51 638 participants and using various counseling and behavioral interventions were included. Trials indicated favorable weight changes with interventions that were statistically significantly different from control groups in 4 of 5 trials of counseling, but not in 2 trials of exercise. Few harms were reported. RECOMMENDATION: The WPSI recommends counseling midlife women aged 40 to 60 years with normal or overweight BMI (18.5 to 29.9 kg/m2) to maintain weight or limit weight gain to prevent obesity. Counseling may include individualized discussion of healthy eating and physical activity.


Overweight , Preventive Health Services , Female , Humans , Obesity/prevention & control , Overweight/complications , Overweight/prevention & control , Weight Gain , Women's Health
13.
Struct Equ Modeling ; 29(3): 452-475, 2022.
Article En | MEDLINE | ID: mdl-35601030

The influx of intensive longitudinal data creates a pressing need for complex modeling tools that help enrich our understanding of how individuals change over time. Multilevel vector autoregressive (mlVAR) models allow for simultaneous evaluations of reciprocal linkages between dynamic processes and individual differences, and have gained increased recognition in recent years. High-dimensional and other complex variations of mlVAR models, though often computationally intractable in the frequentist framework, can be readily handled using Markov chain Monte Carlo techniques in a Bayesian framework. However, researchers in social science fields may be unfamiliar with ways to capitalize on recent developments in Bayesian software programs. In this paper, we provide step-by-step illustrations and comparisons of options to fit Bayesian mlVAR models using Stan, JAGS and Mplus, supplemented with a Monte Carlo simulation study. An empirical example is used to demonstrate the utility of mlVAR models in studying intra- and inter-individual variations in affective dynamics.

14.
J Asthma ; 59(4): 775-779, 2022 04.
Article En | MEDLINE | ID: mdl-33492180

OBJECTIVE: We examined asthma control in children hospitalized for status asthmaticus 7-10 days after discharge with or without an additional prescription for systemic corticosteroids. METHODS: This was a prospective observational study of patients aged 5-17 years with a documented history of asthma or ß-agonist responsive wheezing admitted to the hospital for an acute asthma exacerbation. We compared patients who had any systemic corticosteroid prescribed at discharge with those who were not prescribed systemic corticosteroids at discharge. The primary outcomes were asthma control after discharge, as defined by the Asthma Control Test (ACT), and missed school days, which we modeled with multivariable linear and Poisson regression, respectively. RESULTS: A total of 56 patients were included in the study, 29 (52%) received dexamethasone inpatient and then were discharged without additional prescribed systemic corticosteroids. Those without a corticosteroid prescription at discharge were less likely to have received noninvasive ventilation (p = 0.02), pulmonology consultation (p = 0.02), and continuous albuterol (p = 0.01) during hospitalization. These patients also tended toward shorter length of stay (p = 0.07) compared to those receiving systemic corticosteroid prescription at discharge. In multivariable models, being discharged without systemic corticosteroid prescription was associated with poorer asthma control after discharge [beta (95% CI), -2.21 (-2.65 to -1.77)] and more missed school days [coefficient estimate (95% CI), 0.87 (0.07-1.68)]. CONCLUSIONS: After hospitalization for an asthma exacerbation, patients not given systemic corticosteroids at discharge tended to have worse asthma control following discharge despite having less severe disease and requiring less aggressive inpatient management.Supplemental data for this article can be accessed at publisher's website.


Asthma , Patient Discharge , Adolescent , Adrenal Cortex Hormones/therapeutic use , Asthma/drug therapy , Child , Child, Preschool , Glucocorticoids/therapeutic use , Hospitalization , Humans , Pilot Projects , Prospective Studies
15.
Appetite ; 169: 105817, 2022 02 01.
Article En | MEDLINE | ID: mdl-34826526

Developing healthy eating behaviours is important to assist children in maintaining good health and decrease the risk of chronic health conditions. Recent nutrition promotion efforts in Australian primary schools have mainly focused on canteen guideline compliance and obesity prevention interventions. The aim of this study was to investigate the primary school food environment, specifically, allocated lunch eating duration and the governance of children's lunch breaks. Parents (n = 402) and teachers (n = 123) were asked via an online survey, about school allocated lunch eating duration and its adequacy. Respondents were asked about the supervision, monitoring and feedback of children's lunches, as well as how they felt about these practices. Parents (n = 308) and teachers (n = 102) also responded to the open-ended question "What could be done to improve the school food environment at your school?". Ten minutes was the allocated lunch eating duration reported by most parents and teachers and 58% of those parents and 30% of those teachers rated this as inadequate. Increasing the allocated lunch eating duration was frequently cited as a way to improve the school food environment. A similar proportion of parents and teachers agreed with teachers monitoring food intake, not providing feedback on food brought to school, and that parents should decide what children eat. More parents (44%) than teachers (23%) believed that teachers should eat their own lunch with the children. These findings provide an insight into the primary school lunch environment and the views of two key stakeholder groups. School food policies should consider these findings in future revisions, particularly with regards to eating times.


Food Services , Lunch , Australia , Child , Eating , Humans , Schools
17.
Radiol Technol ; 92(4): 383M-398M, 2021 Mar.
Article En | MEDLINE | ID: mdl-33653931

Mammary duct ectasia is a benign breast condition of unknown etiology. Patients with ductal ectasia might have no symptoms or might present with symptoms so severe that surgery is indicated. Symptomatic patients require a full and careful workup because ductal ectasia in advanced stages can be mistaken for carcinoma of the breast. These patients are likely to undergo mammography, sonography, magnetic resonance imaging, and galactography. Therefore, radiologic technologists are involved directly with their imaging and care.


Breast Diseases , Dilatation, Pathologic , Breast , Breast Diseases/diagnostic imaging , Breast Diseases/therapy , Humans , Magnetic Resonance Imaging , Mammography
18.
J Particip Med ; 13(1): e23011, 2021 Mar 29.
Article En | MEDLINE | ID: mdl-33779573

Sharing clinical trial data can provide value to research participants and communities by accelerating the development of new knowledge and therapies as investigators merge data sets to conduct new analyses, reproduce published findings to raise standards for original research, and learn from the work of others to generate new research questions. Nonprofit funders, including disease advocacy and patient-focused organizations, play a pivotal role in the promotion and implementation of data sharing policies. Funders are uniquely positioned to promote and support a culture of data sharing by serving as trusted liaisons between potential research participants and investigators who wish to access these participants' networks for clinical trial recruitment. In short, nonprofit funders can drive policies and influence research culture. The purpose of this paper is to detail a set of aspirational goals and forward thinking, collaborative data sharing solutions for nonprofit funders to fold into existing funding policies. The goals of this paper convey the complexity of the opportunities and challenges facing nonprofit funders and the appropriate prioritization of data sharing within their organizations and may serve as a starting point for a data sharing toolkit for nonprofit funders of clinical trials to provide the clarity of mission and mechanisms to enforce the data sharing practices their communities already expect are happening.

19.
Trials ; 22(1): 153, 2021 Feb 18.
Article En | MEDLINE | ID: mdl-33602275

BACKGROUND: The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is not the norm, but the unprecedented pandemic caused by SARS-CoV-2 may serve as an impetus for greater data sharing. We sought to assess the data sharing intentions of interventional COVID-19 trials as declared in trial registrations and publications. METHODS: We searched ClinicalTrials.gov and PubMed for COVID-19 interventional trials. We analyzed responses to ClinicalTrials.gov fields regarding intent to share individual participant level data and analyzed the data sharing statements in eligible publications. RESULTS: Nine hundred twenty-four trial registrations were analyzed. 15.7% were willing to share, of which 38.6% were willing to share immediately upon publication of results. 47.6% declared they were not willing to share. Twenty-eight publications were analyzed representing 26 unique COVID-19 trials. Only seven publications contained data sharing statements; six indicated a willingness to share data whereas one indicated that data was not available for sharing. CONCLUSIONS: At a time of pressing need for researchers to work together to combat a global pandemic, intent to share individual participant-level data from COVID-19 interventional trials is limited.


COVID-19/therapy , Clinical Trials as Topic/statistics & numerical data , Information Dissemination , Publications/statistics & numerical data , Research Design/statistics & numerical data , COVID-19/epidemiology , Humans , Intention , Pandemics/prevention & control
20.
BMJ Open ; 10(10): e039326, 2020 10 29.
Article En | MEDLINE | ID: mdl-33122319

OBJECTIVE: Clinical trial data sharing has the potential to accelerate scientific progress, answer new lines of scientific inquiry, support reproducibility and prevent redundancy. Vivli, a non-profit organisation, operates a global platform for sharing of individual participant-level trial data and associated documents. Sharing of these data collected from each trial participant enables combining of these data to drive new scientific insights or assess reproducibility-not possible with the aggregate or summary data tables historically made available. We report on our initial experience including key metrics, lessons learned and how we see our role in the data sharing ecosystem. We also describe how Vivli is addressing the needs of the COVID-19 challenge through a new dedicated portal that provides a direct search function for COVID-19 studies, availability for fast-tracked request review and data sharing. DATA SUMMARY: The Vivli platform was established in 2018 and has partnered with 28 diverse members from industry, academic institutions, government platforms and non-profit foundations. Currently, 5400 trials representing 3.6 million participants are shared on the platform. From July 2018 to September 2020, Vivli received 201 requests. To date, 106 of 201 requests received approval, 5 have been declined, 27 withdrew and 27 are in the revision stage. CONCLUSIONS: The pandemic has only magnified the necessity for data sharing. If most data are shared and in a manner that allows interoperability, then we have hope of moving towards a cohesive scientific understanding more quickly not only for COVID-19 but also for all diseases. Conversely, if only isolated pockets of data are shared then society loses the opportunity to close vital gaps in our understanding of this rapidly evolving epidemic. This current challenge serves to highlight the value of data sharing platforms-critical enablers that help researchers build on prior knowledge.


Clinical Trials as Topic , Coronavirus Infections , Data Management , Information Dissemination/methods , Information Services , Pandemics , Pneumonia, Viral , Public Health/trends , Betacoronavirus , Biomedical Research/methods , Biomedical Research/statistics & numerical data , COVID-19 , Coronavirus Infections/prevention & control , Coronavirus Infections/therapy , Data Management/methods , Data Management/organization & administration , Data Management/trends , Humans , Information Services/organization & administration , Information Services/trends , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pneumonia, Viral/therapy , Research Design , SARS-CoV-2
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