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The vegetation at and beyond the northern edge of the world’s boreal forest plays an important though imperfectly understood role in the climate system. This is particularly true within Russia, where only a small proportion of the boreal land area has been studied in depth, and little is known about its recent evolution over time. We describe a long-term collaboration between institutions in Russia and the United Kingdom, aimed at developing a better understanding of high-latitude vegetation in Russia using remote sensing methods. The focus of the collaboration has varied over time; in its most recent form, it is concerned with the dynamics of the Russian boreal forest during the 21st century and its relation to climate change. We discuss the support framework within which it has been developed and reflect on its relationship to science diplomacy. We consider the factors that have contributed to the success of a decades-long international collaboration and make recommendations as to how such joint efforts can be encouraged in future.
The target article misrepresents the foundations of integrated information theory (IIT) and ignores many essential publications. It, thus, falls to this lead commentary to outline the axioms and postulates of IIT and correct major misconceptions. The commentary also explains why IIT starts from phenomenology and why it predicts that only select physical substrates can support consciousness. Finally, it highlights that IIT's account of experience – a cause–effect structure quantified by integrated information – has nothing to do with “information transfer.”
This study reviewed all rhinology clinical negligence claims in the National Health Service in England between 2013 and 2018.
All clinical negligence claims held by National Health Service Resolution relating to rhinology in England between 1 April 2013 and 1 April 2018 were reviewed.
There were 171 rhinology related claims with a total estimated potential cost of £13.6 million. There were 119 closed claims (70 per cent) with a total cost of £2.3 million, of which 55 claims resulted in payment of damages. Over three quarters of all rhinology claims were associated with surgery (n = 132). Claims associated with endoscopic sinus surgery had the highest mean cost per claim (£172 978). Unnecessary pain (33.9 per cent) and unnecessary operation (28.1 per cent) were the most commonly cited patient injuries.
Patient education and consent have been highlighted as key areas for improvement from this review of rhinology related clinical negligence claims. A shift in clinical practice towards shared decision making could reduce litigation in rhinology.
To examine cross-sectional associations between farmers’ market shopping behaviours and objectively measured and self-reported fruit and vegetable (FV) intake among rural North Carolina (NC) and New York City (NYC) shoppers.
Cross-sectional intercept surveys were used to assess self-reported FV intake and three measures of farmers’ market shopping behaviour: (1) frequency of purchasing FV; (2) variety of FV purchased and (3) dollars spent on FV. Skin carotenoids, a non-invasive biomarker for FV intake, were objectively measured using pressure-mediated reflection spectroscopy. Associations between farmers’ market shopping behaviours and FV intake were examined using regression models that controlled for demographic variables (e.g. age, sex, race, smoking status, education, income and state).
Farmers’ markets (n 17 markets) in rural NC and NYC.
A convenience sample of 645 farmers’ market shoppers.
Farmers’ market shoppers in NYC purchased a greater variety of FV and had higher skin carotenoid scores compared with shoppers in rural NC. Among all shoppers, there was a positive, statistically significant association between self-reported frequency of shopping at farmers’ markets and self-reported as well as objectively assessed FV intake. The variety of FV purchased and farmers’ market spending on FV also were positively associated with self-reported FV intake, but not skin carotenoids.
Those who shop for FV more frequently at a farmers’ markets, purchase a greater variety of FV and spend more money on FV have higher self-reported, and in some cases higher objectively measured FV intake. Further research is needed to understand these associations and test causality.
Substantial progress has been made in the standardization of nomenclature for paediatric and congenital cardiac care. In 1936, Maude Abbott published her Atlas of Congenital Cardiac Disease, which was the first formal attempt to classify congenital heart disease. The International Paediatric and Congenital Cardiac Code (IPCCC) is now utilized worldwide and has most recently become the paediatric and congenital cardiac component of the Eleventh Revision of the International Classification of Diseases (ICD-11). The most recent publication of the IPCCC was in 2017. This manuscript provides an updated 2021 version of the IPCCC.
The International Society for Nomenclature of Paediatric and Congenital Heart Disease (ISNPCHD), in collaboration with the World Health Organization (WHO), developed the paediatric and congenital cardiac nomenclature that is now within the eleventh version of the International Classification of Diseases (ICD-11). This unification of IPCCC and ICD-11 is the IPCCC ICD-11 Nomenclature and is the first time that the clinical nomenclature for paediatric and congenital cardiac care and the administrative nomenclature for paediatric and congenital cardiac care are harmonized. The resultant congenital cardiac component of ICD-11 was increased from 29 congenital cardiac codes in ICD-9 and 73 congenital cardiac codes in ICD-10 to 318 codes submitted by ISNPCHD through 2018 for incorporation into ICD-11. After these 318 terms were incorporated into ICD-11 in 2018, the WHO ICD-11 team added an additional 49 terms, some of which are acceptable legacy terms from ICD-10, while others provide greater granularity than the ISNPCHD thought was originally acceptable. Thus, the total number of paediatric and congenital cardiac terms in ICD-11 is 367. In this manuscript, we describe and review the terminology, hierarchy, and definitions of the IPCCC ICD-11 Nomenclature. This article, therefore, presents a global system of nomenclature for paediatric and congenital cardiac care that unifies clinical and administrative nomenclature.
The members of ISNPCHD realize that the nomenclature published in this manuscript will continue to evolve. The version of the IPCCC that was published in 2017 has evolved and changed, and it is now replaced by this 2021 version. In the future, ISNPCHD will again publish updated versions of IPCCC, as IPCCC continues to evolve.
To examine associations between maternal characteristics and feeding styles in Caribbean mothers.
Participants were mother–child pairs enrolled in a cluster randomised trial of a parenting intervention in three Caribbean islands. Maternal characteristics were obtained by questionnaires when infants were 6–8 weeks old. Items adapted from the Toddler Feeding Behaviour Questionnaire were used to assess infant feeding styles at the age of 1 year. Feeding styles were identified using factor analysis and associations with maternal characteristics assessed using multilevel linear regression.
Health clinics in St. Lucia (n 9), Antigua (n 10) and Jamaica (n 20).
A total of 405 mother–child pairs from the larger trial.
Maternal depressive symptoms were associated with uninvolved (β = 0·38, 95 % CI (0·14, 0·62)), restrictive (β = 0·44, 95 % CI (0·19, 0·69)) and forceful (β = 0·31, 95 % CI (0·06, 0·57)) feeding and inversely associated with responsive feeding (β = −0·30, 95 % CI (−0·56, −0·05)). Maternal vocabulary was inversely associated with uninvolved (β = −0·31, 95 % CI (−0·57, −0·06)), restrictive (β = −0·30, 95 % CI (−0·56, −0·04)), indulgent (β = −0·47, 95 % CI (−0·73, −0·21)) and forceful (β = −0·54, 95 % CI (−0·81, −0·28)) feeding. Indulgent feeding was negatively associated with socio-economic status (β = −0·27, 95 % CI (−0·53, −0·00)) and was lower among mothers ≥35 years (β = −0·32, 95 % CI (−0·62, −0·02)). Breast-feeding at 1 year was associated with forceful feeding (β = 0·41, 95 % CI (0·21, 0·61)). No significant associations were found between maternal education, BMI, occupation and feeding styles.
Services to identify and assist mothers with depressive symptoms may benefit infant feeding style. Interventions to promote responsive feeding may be important for less educated, younger and socio-economically disadvantaged mothers.
ABSTRACT IMPACT: Identifying factors associated with opioid overdoses will enable better resource allocation in communities most impacted by the overdose epidemic. OBJECTIVES/GOALS: Opioid overdoses often occur in hotspots identified by geographic and temporal trends. This study uses principles of community engaged research to identify neighborhood and community-level factors associated with opioid overdose within overdose hotspots which can be targets for novel intervention design. METHODS/STUDY POPULATION: We conducted an environmental scan in three overdose hotspots’‘ two in an urban center and one in a small city’‘ identified by the Rhode Island Department of Health as having the highest opioid overdose burden in Rhode Island. We engaged hotspot community stakeholders to identify neighborhood factors to map within each hotspot. Locations of addiction treatment, public transportation, harm reduction programs, public facilities (i.e., libraries, parks), first responders, and social services agencies were converted to latitude and longitude and mapped in ArcGIS. Using Esri Service Areas, we will evaluate the service areas of stationary services. We will overlay overdose events and use logistic regression identify neighborhood factors associated with overdose by comparing hotspot and non-hotspot neighborhoods. RESULTS/ANTICIPATED RESULTS: We anticipate that there will be differing neighborhood characteristics associated with overdose events in the densely populated urban area and those in the smaller city. The urban area hotspots will have overlapping social services, addiction treatment, and transportation service areas, while the small city will have fewer community resources without overlapping service areas and reduced public transportation access. We anticipate that overdoses will occur during times of the day when services are not available. Overall, overdose hotspots will be associated with increased census block level unemployment, homelessness, vacant housing, and low food security. DISCUSSION/SIGNIFICANCE OF FINDINGS: Identifying factors associated with opioid overdoses will enable better resource allocation in communities most impacted by the overdose epidemic. Study results will be used for novel intervention design to prevent opioid overdose deaths in communities with high burden of opioid overdose.
Insular species, particularly birds, experience high levels of speciation and endemism. Similarly, island birds experience extreme levels of extinction. Based on a 2012 taxonomic assessment, historically there were four reed-warbler species in the Mariana Islands, the Guam Reed-warbler Acrocephalus luscinia (Guam), the Nightingale Reed-warbler Acrocephalus hiwae (Saipan and Alamagan), the Aguijuan Reed-warbler A. nijoi (Aguiguan or Aguijuan), and the Pagan Reed-warbler A. yamashinae (Pagan). Between 2008 and 2010 we surveyed for three of these species on Alamagan, Aguiguan, and Pagan. Our results indicate that reed-warblers are extinct on Aguiguan, likely extinct on Pagan, and only the Nightingale Reed-warbler on Alamagan and Saipan remains. We estimated the global population at between 1,019 and 6,356 birds (95% CI; mean estimate 3,688), which has declined by more than 1,000 birds since the first quantitative surveys were conducted in 1982, i.e. a 24% decline in 28 years. Camp et al. (2009) describe the status of the Nightingale Reed-warbler on Saipan, which has also declined. We estimated the Alamagan population to be between 428 and 1,762 birds in 2010 (mean estimate 946). Thus, the Alamagan population is ~25 % of the global population, and it has declined slightly since 2000. This decline was not significant but is concerning, especially given a similar decline on Saipan. Restoration and protection of tall-stature native and secondary forest could benefit the Alamagan population, as would similar conservation on Saipan that includes wetland habitat. After suitable restoration of forest and wetland habitats on Aguiguan, Guam and Pagan, individuals from Alamagan and Saipan could serve as founder populations. Careful consideration of the extent and habitat preference of individuals translocated to Tinian, where an unknown reed-warbler species previously occurred, is warranted.
We present continuous estimates of snow and firn density, layer depth and accumulation from a multi-channel, multi-offset, ground-penetrating radar traverse. Our method uses the electromagnetic velocity, estimated from waveform travel-times measured at common-midpoints between sources and receivers. Previously, common-midpoint radar experiments on ice sheets have been limited to point observations. We completed radar velocity analysis in the upper ~2 m to estimate the surface and average snow density of the Greenland Ice Sheet. We parameterized the Herron and Langway (1980) firn density and age model using the radar-derived snow density, radar-derived surface mass balance (2015–2017) and reanalysis-derived temperature data. We applied structure-oriented filtering to the radar image along constant age horizons and increased the depth at which horizons could be reliably interpreted. We reconstructed the historical instantaneous surface mass balance, which we averaged into annual and multidecadal products along a 78 km traverse for the period 1984–2017. We found good agreement between our physically constrained parameterization and a firn core collected from the dry snow accumulation zone, and gained insights into the spatial correlation of surface snow density.
To conduct a pilot study implementing combined genomic and epidemiologic surveillance for hospital-acquired multidrug-resistant organisms (MDROs) to predict transmission between patients and to estimate the local burden of MDRO transmission.
Pilot prospective multicenter surveillance study.
The study was conducted in 8 university hospitals (2,800 beds total) in Melbourne, Australia (population 4.8 million), including 4 acute-care, 1 specialist cancer care, and 3 subacute-care hospitals.
All clinical and screening isolates from hospital inpatients (April 24 to June 18, 2017) were collected for 6 MDROs: vanA VRE, MRSA, ESBL Escherichia coli (ESBL-Ec) and Klebsiella pneumoniae (ESBL-Kp), and carbapenem-resistant Pseudomonas aeruginosa (CRPa) and Acinetobacter baumannii (CRAb). Isolates were analyzed and reported as routine by hospital laboratories, underwent whole-genome sequencing at the central laboratory, and were analyzed using open-source bioinformatic tools. MDRO burden and transmission were assessed using combined genomic and epidemiologic data.
In total, 408 isolates were collected from 358 patients; 47.5% were screening isolates. ESBL-Ec was most common (52.5%), then MRSA (21.6%), vanA VRE (15.7%), and ESBL-Kp (7.6%). Most MDROs (88.3%) were isolated from patients with recent healthcare exposure.
Combining genomics and epidemiology identified that at least 27.1% of MDROs were likely acquired in a hospital; most of these transmission events would not have been detected without genomics. The highest proportion of transmission occurred with vanA VRE (88.4% of patients).
Genomic and epidemiologic data from multiple institutions can feasibly be combined prospectively, providing substantial insights into the burden and distribution of MDROs, including in-hospital transmission. This analysis enables infection control teams to target interventions more effectively.
Treatment resistance causes significant burden in psychosis. Clozapine is the only evidence-based pharmacologic intervention available for people with treatment-resistant schizophrenia; current guidelines recommend commencement after two unsuccessful trials of standard antipsychotics.
This paper aims to explore the prevalence of treatment resistance and pathways to commencement of clozapine in UK early intervention in psychosis (EIP) services.
Data were taken from the National Evaluation of the Development and Impact of Early Intervention Services study (N = 1027) and included demographics, medication history and psychosis symptoms measured by the Positive and Negative Syndrome Scale (PANSS) at baseline, 6 months and 12 months. Prescribing patterns and pathways to clozapine were examined. We adopted a strict criterion for treatment resistance, defined as persistent elevated positive symptoms (a PANSS positive score ≥16, equating to at least two items of at least moderate severity), across three time points.
A total of 143 (18.1%) participants met the definition of treatment resistance of having continuous positive symptoms over 12 months, despite treatment in EIP services. Sixty-one (7.7%) participants were treatment resistant and eligible for clozapine, having had two trials of standard antipsychotics; however, only 25 (2.4%) were prescribed clozapine over the 12-month study period. Treatment-resistant participants were more likely to be prescribed additional antipsychotic medication and polypharmacy, instead of clozapine.
Prevalent treatment resistance was observed in UK EIP services, but prescription of polypharmacy was much more common than clozapine. Significant delays in the commencement of clozapine may reflect a missed opportunity to promote recovery in this critical period.
To evaluate whether incorporating mandatory prior authorization for Clostridioides difficile testing into antimicrobial stewardship pharmacist workflow could reduce testing in patients with alternative etiologies for diarrhea.
Single center, quasi-experimental before-and-after study.
Tertiary-care, academic medical center in Ann Arbor, Michigan.
Adult and pediatric patients admitted between September 11, 2019 and December 10, 2019 were included if they had an order placed for 1 of the following: (1) C. difficile enzyme immunoassay (EIA) in patients hospitalized >72 hours and received laxatives, oral contrast, or initiated tube feeds within the prior 48 hours, (2) repeat molecular multiplex gastrointestinal pathogen panel (GIPAN) testing, or (3) GIPAN testing in patients hospitalized >72 hours.
A best-practice alert prompting prior authorization by the antimicrobial stewardship program (ASP) for EIA or GIPAN testing was implemented. Approval required the provider to page the ASP pharmacist and discuss rationale for testing. The provider could not proceed with the order if ASP approval was not obtained.
An average of 2.5 requests per day were received over the 3-month intervention period. The weekly rate of EIA and GIPAN orders per 1,000 patient days decreased significantly from 6.05 ± 0.94 to 4.87 ± 0.78 (IRR, 0.72; 95% CI, 0.56–0.93; P = .010) and from 1.72 ± 0.37 to 0.89 ± 0.29 (IRR, 0.53; 95% CI, 0.37–0.77; P = .001), respectively.
We identified an efficient, effective C. difficile and GIPAN diagnostic stewardship approval model.
Registry-based trials have emerged as a potentially cost-saving study methodology. Early estimates of cost savings, however, conflated the benefits associated with registry utilisation and those associated with other aspects of pragmatic trial designs, which might not all be as broadly applicable. In this study, we sought to build a practical tool that investigators could use across disciplines to estimate the ranges of potential cost differences associated with implementing registry-based trials versus standard clinical trials.
We built simulation Markov models to compare unique costs associated with data acquisition, cleaning, and linkage under a registry-based trial design versus a standard clinical trial. We conducted one-way, two-way, and probabilistic sensitivity analyses, varying study characteristics over broad ranges, to determine thresholds at which investigators might optimally select each trial design.
Registry-based trials were more cost effective than standard clinical trials 98.6% of the time. Data-related cost savings ranged from $4300 to $600,000 with variation in study characteristics. Cost differences were most reactive to the number of patients in a study, the number of data elements per patient available in a registry, and the speed with which research coordinators could manually abstract data. Registry incorporation resulted in cost savings when as few as 3768 independent data elements were available and when manual data abstraction took as little as 3.4 seconds per data field.
Registries offer important resources for investigators. When available, their broad incorporation may help the scientific community reduce the costs of clinical investigation. We offer here a practical tool for investigators to assess potential costs savings.
At present, analysis of diet and bladder cancer (BC) is mostly based on the intake of individual foods. The examination of food combinations provides a scope to deal with the complexity and unpredictability of the diet and aims to overcome the limitations of the study of nutrients and foods in isolation. This article aims to demonstrate the usability of supervised data mining methods to extract the food groups related to BC. In order to derive key food groups associated with BC risk, we applied the data mining technique C5.0 with 10-fold cross-validation in the BLadder cancer Epidemiology and Nutritional Determinants study, including data from eighteen case–control and one nested case–cohort study, compromising 8320 BC cases out of 31 551 participants. Dietary data, on the eleven main food groups of the Eurocode 2 Core classification codebook, and relevant non-diet data (i.e. sex, age and smoking status) were available. Primarily, five key food groups were extracted; in order of importance, beverages (non-milk); grains and grain products; vegetables and vegetable products; fats, oils and their products; meats and meat products were associated with BC risk. Since these food groups are corresponded with previously proposed BC-related dietary factors, data mining seems to be a promising technique in the field of nutritional epidemiology and deserves further examination.
Clinical diagnostics in sudden onset disasters have historically been limited. We set out to design, implement, and evaluate a mobile diagnostic laboratory accompanying a type 2 emergency medical team (EMT) field hospital.
Available diagnostic platforms were reviewed and selected against in field need. Platforms included HemoCue301/WBC DIFF, i-STAT, BIOFIRE FILMARRAY multiplex rt-PCR, Olympus BX53 microscopy, ABO/Rh grouping, and specific rapid diagnostic tests. This equipment was trialed in Katherine, Australia, and Dili, Timor-Leste.
During the initial deployment, an evaluation of FilmArray tests was successful using blood culture identification, gastrointestinal, and respiratory panels. HemoCue301 (n = 20) hemoglobin values were compared on Sysmex XN 550 (r = 0.94). HemoCue WBC DIFF had some variation, dependent on the cell, when compared with Sysmex XN 550 (r = 0.88-0.16). i-STAT showed nonsignificant differences against Vitros 250. Further evaluation of FilmArray in Dili, Timor-Leste, diagnosed 117 pathogens on 168 FilmArray pouches, including 25 separate organisms on blood culture and 4 separate cerebrospinal fluid pathogens.
This mobile laboratory represents a major advance in sudden onset disaster. Setup of the service was quick (< 24 hr) and transport to site rapid. Future deployment in fragmented health systems after sudden onset disasters with EMT2 will now allow broader diagnostic capability.
Neurocognitive and functional neuroimaging studies point to frontal lobe abnormalities in schizophrenia. Molecular and behavioural genetic studies suggest that the frontal lobe is under significant genetic influence. We carried out structural magnetic resonance imaging (MRI) of the frontal lobe in monozygotic (MZ) twins concordant or discordant for schizophrenia and healthy MZ control twins.
The sample comprised 21 concordant pairs, 17 discordant affected and 18 discordant unaffected twins from 19 discordant pairs, and 27 control pairs. Groups were matched on sociodemographic variables. Patient groups (concordant, discordant affected) did not differ on clinical variables. Volumes of superior, middle, inferior and orbital frontal gyri were calculated using the Cavalieri principle on the basis of manual tracing of anatomic boundaries. Group differences were investigated covarying for whole-brain volume, gender and age.
Results for superior frontal gyrus showed that twins with schizophrenia (i.e. concordant twins and discordant affected twins) had reduced volume compared to twins without schizophrenia (i.e. discordant unaffected and control twins), indicating an effect of illness. For middle and orbital frontal gyrus, concordant (but not discordant affected) twins differed from non-schizophrenic twins. There were no group differences in inferior frontal gyrus volume.
These findings suggest that volume reductions in the superior frontal gyrus are associated with a diagnosis of schizophrenia (in the presence or absence of a co-twin with schizophrenia). On the other hand, volume reductions in middle and orbital frontal gyri are seen only in concordant pairs, perhaps reflecting the increased genetic vulnerability in this group.
Campylobacteriosis is the most common notifiable disease in New Zealand. While the risk of campylobacteriosis has been found to be strongly associated with the consumption of undercooked poultry, other risk factors include rainwater-sourced drinking water, contact with animals and consumption of raw dairy products. Despite this, there has been little investigation of raw milk as a risk factor for campylobacteriosis. Recent increases in demand for untreated or ‘raw’ milk have also raised concerns that this exposure may become a more important source of disease in the future. This study describes the cases of notified campylobacteriosis from a sentinel surveillance site. Previously collected data from notified cases of raw milk-associated campylobacteriosis were examined and compared with campylobacteriosis cases who did not report raw milk consumption. Raw milk campylobacteriosis cases differed from non-raw milk cases on comparison of age and occupation demographics, with raw milk cases more likely to be younger and categorised as children or students for occupation. Raw milk cases were more likely to be associated with outbreaks than non-raw milk cases. Study-suggested motivations for raw milk consumption (health reasons, natural product, produced on farm, inexpensive or to support locals) were not strongly supported by cases. More information about the raw milk consumption habits of New Zealanders would be helpful to better understand the risks of this disease, especially with respect to increased disease risk observed in younger people. Further discussion with raw milk consumers around their motivations may also be useful to find common ground between public health concerns and consumer preferences as efforts continue to manage this ongoing public health issue.
Clinical Enterobacteriacae isolates with a colistin minimum inhibitory concentration (MIC) ≥4 mg/L from a United States hospital were screened for the mcr-1 gene using real-time polymerase chain reaction (RT-PCR) and confirmed by whole-genome sequencing. Four colistin-resistant Escherichia coli isolates contained mcr-1. Two isolates belonged to the same sequence type (ST-632). All subjects had prior international travel and antimicrobial exposure.
To evaluate the association between novel pre- and post-operative biomarker levels and 30-day unplanned readmission or mortality after paediatric congenital heart surgery.
Children aged 18 years or younger undergoing congenital heart surgery (n = 162) at Johns Hopkins Hospital from 2010 to 2014 were enrolled in the prospective cohort. Collected novel pre- and post-operative biomarkers include soluble suppression of tumorgenicity 2, galectin-3, N-terminal prohormone of brain natriuretic peptide, and glial fibrillary acidic protein. A model based on clinical variables from the Society of Thoracic Surgery database was developed and evaluated against two augmented models.
Unplanned readmission or mortality within 30 days of cardiac surgery occurred among 21 (13%) children. The clinical model augmented with pre-operative biomarkers demonstrated a statistically significant improvement over the clinical model alone with a receiver-operating characteristics curve of 0.754 (95% confidence interval: 0.65–0.86) compared to 0.617 (95% confidence interval: 0.47–0.76; p-value: 0.012). The clinical model augmented with pre- and post-operative biomarkers demonstrated a significant improvement over the clinical model alone, with a receiver-operating characteristics curve of 0.802 (95% confidence interval: 0.72–0.89; p-value: 0.003).
Novel biomarkers add significant predictive value when assessing the likelihood of unplanned readmission or mortality after paediatric congenital heart surgery. Further exploration of the utility of these novel biomarkers during the pre- or post-operative period to identify early risk of mortality or readmission will aid in determining the clinical utility and application of these biomarkers into routine risk assessment.
Using existing data from clinical registries to support clinical trials and other prospective studies has the potential to improve research efficiency. However, little has been reported about staff experiences and lessons learned from implementation of this method in pediatric cardiology.
We describe the process of using existing registry data in the Pediatric Heart Network Residual Lesion Score Study, report stakeholders’ perspectives, and provide recommendations to guide future studies using this methodology.
The Residual Lesion Score Study, a 17-site prospective, observational study, piloted the use of existing local surgical registry data (collected for submission to the Society of Thoracic Surgeons-Congenital Heart Surgery Database) to supplement manual data collection. A survey regarding processes and perceptions was administered to study site and data coordinating center staff.
Survey response rate was 98% (54/55). Overall, 57% perceived that using registry data saved research staff time in the current study, and 74% perceived that it would save time in future studies; 55% noted significant upfront time in developing a methodology for extracting registry data. Survey recommendations included simplifying data extraction processes and tailoring to the needs of the study, understanding registry characteristics to maximise data quality and security, and involving all stakeholders in design and implementation processes.
Use of existing registry data was perceived to save time and promote efficiency. Consideration must be given to the upfront investment of time and resources needed. Ongoing efforts focussed on automating and centralising data management may aid in further optimising this methodology for future studies.