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A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data.

ABSTRACT: BACKGROUND:We aimed to test whether a common set of key data items reported across high-impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonatal data held in the National Neonatal Research Database (NNRD). METHODS:We systematically reviewed neonatal clinical trials published in four high-impact medical journals over 10?years (2006-2015) and extracted baseline characteristics, stratification items and potential confounders used to adjust primary outcomes. Completeness was examined using data held in the NNRD for identified data items, for infants admitted to neonatal units in 2015. The NNRD is a repository of routinely recorded data extracted from neonatal Electronic Patient Records (EPR) of all admissions to National Health Service (NHS) Neonatal Units in England, Wales and Scotland. We defined missing data as an empty field or an implausible value. We reported common data items as frequencies and percentages alongside percentages of completeness. RESULTS:We identified 44 studies involving 32,095 infants and 126 data items. Fourteen data items were reported by more than 20% of studies. Gestational age (95%), sex (93%) and birth weight (91%) were the most common baseline data items. The completeness of data in the NNRD was high for these data with greater than 90% completeness found for 9 of the 14 most common items. CONCLUSION:High-impact neonatal clinical trials share common data items. In the United Kingdom, these items can be obtained at a high level of completeness from routinely recorded data held in the NNRD. The feasibility and efficiency using routinely recorded EPR data, such as that held in the NNRD, for clinical trials, rather than collecting these items anew, should be examined. TRIAL REGISTRATION:PROSPERO registration number CRD42016046138. Registered prospectively on 17 August 2016.

SUBMITTER: Jawad S

PROVIDER: S-EPMC6915866 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data.

Jawad Sena S Modi Neena N Prevost A Toby AT Gale Chris C

Trials 20191216 1

<h4>Background</h4>We aimed to test whether a common set of key data items reported across high-impact neonatal clinical trials could be identified, and to quantify their completeness in routinely recorded United Kingdom neonatal data held in the National Neonatal Research Database (NNRD).<h4>Methods</h4>We systematically reviewed neonatal clinical trials published in four high-impact medical journals over 10 years (2006-2015) and extracted baseline characteristics, stratification items and pote ...[more]

PMID: 31842960

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Project description:IntroductionTherapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.Methods and analysisWe will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.Ethics and disseminationIn this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby's data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents.Trial registration numberNCT03278847; pre-results, ISRCTN47404296; pre-results.

Project description:BackgroundThere has been a resurgence of tuberculosis worldwide, mainly in developing countries but also affecting the United Kingdom (UK), and other Western countries. The control of tuberculosis is dependent on early identification of cases and timely notification to public health departments to ensure appropriate treatment of cases and screening of contacts. Tuberculosis is compulsorily notifiable in the UK, and the doctor making or suspecting the diagnosis is legally responsible for notification. There is evidence of under-reporting of tuberculosis. This has implications for the control of tuberculosis as a disproportionate number of people who become infected are the most vulnerable in society, and are less likely to be identified and notified to the public health system. These include the poor, the homeless, refugees and ethnic minorities.MethodThis study was a critical literature review on completeness of tuberculosis notification within the UK National Health Service (NHS) context. The review also identified data sources associated with reporting completeness and assessed whether studies corrected for undercount using capture-recapture (CR) methodology. Studies were included if they assessed completeness of tuberculosis notification quantitatively. The outcome measure used was notification completeness expressed between 0% and 100% of a defined denominator, or in numbers not notified where the denominator was unknown.ResultsSeven studies that met the inclusion and exclusion criteria were identified through electronic and manual search of published and unpublished literature. One study used CR methodology. Analysis of the seven studies showed that undernotification varied from 7% to 27% in studies that had a denominator; and 38%-49% extra cases were identified in studies which examined specific data sources like pathology reports or prescriptions for anti-tuberculosis drugs. Cases notified were more likely to have positive microbiology than cases not notified which were more likely to have positive histopathology or be surgical in-patients. Collation of prescription data of two or more anti-tuberculosis drugs increases case ascertainment of tuberculosis.ConclusionThe reporting of tuberculosis is incomplete in the UK, although notification is a statutory requirement. Undernotification leads to an underestimation of the disease burden and hinders implementation of appropriate prevention and control strategies. The notification system needs to be strengthened to include education and training of all sub-specialities involved in diagnosis and treatment of tuberculosis.

Project description:BackgroundRoutinely recorded data held in electronic health records can be used to inform the conduct of randomised controlled trials (RCTs). However, limitations with access and accuracy have been identified.ObjectiveUsing epilepsy as an exemplar condition, we assessed the attributes and agreement of routinely recorded data compared to data collected using case report forms in a UK RCT assessing antiepileptic drug treatments for individuals newly diagnosed with epilepsy.MethodsThe case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK multicentre RCT assessing the clinical and cost-effectiveness of antiepileptic drugs as treatments for epilepsy. Ninety-eight of 470 eligible participants provided consent for access to routinely recorded secondary care data that were retrieved from NHS Digital Hospital Episode Statistics (N=71) and primary and secondary care data from The Secure Anonymised Information Linkage Databank (N=27). We assessed data items relevant to the identification of individuals eligible for inclusion in SANAD II, baseline and follow-up visits. The attributes of routinely recorded data were assessed including the degree of missing data. The agreement between routinely recorded data and data collected on case report forms in SANAD II was assessed using calculation of Cohen's kappa for categorical data and construction of Bland-Altman plots for continuous data.ResultsThere was a significant degree of missing data in the routine record for 15 of the 20 variables assessed, including all clinical variables. Agreement was poor for the majority of comparisons, including the assessments of seizure occurrence and adverse events. For example, only 23/62 (37%) participants had a date of first-ever seizure identified in routine datasets. Agreement was satisfactory for the date of prescription of antiepileptic drugs and episodes of healthcare resource use.ConclusionsThere are currently significant limitations preventing the use of routinely recorded data for participant identification and assessment of clinical outcomes in epilepsy, and potentially other chronic conditions. Further research is urgently required to assess the attributes, agreement, additional benefits, cost-effectiveness and 'optimal mix' of routinely recorded data compared to data collected using standard methods such as case report forms at clinic visits for people with epilepsy.Trial registrationStandard and New Antiepileptic Drugs II (SANAD II (EudraCT No: 2012-001884-64, registered 05/09/2012; ISRCTN Number: ISRCTN30294119 , registered 03/07/2012)).

Project description:BackgroundCause-specific mortality data are required to set interventions to reduce neonatal mortality. However, in many developing countries, these data are either lacking or of low quality. We assessed the completeness and accuracy of cause of death (COD) data for neonates in Ghana to assess their usability for monitoring the effectiveness of health system interventions aimed at improving neonatal survival.MethodsA lot quality assurance sampling survey was conducted in 20 hospitals in the public sector across four regions of Ghana. Institutional neonatal deaths (IND) occurring from 2014 through 2017 were divided into lots, defined as neonatal deaths occurring in a selected facility in a calendar year. A total of 52 eligible lots were selected: 10 from Ashanti region, and 14 each from Brong Ahafo, Eastern and Volta region. Nine lots were from 2014, 11 from 2015 and 16 each were from 2016 and 2017. The cause of death (COD) of 20 IND per lot were abstracted from admission and discharge (A&D) registers and validated against the COD recorded in death certificates, clinician's notes or neonatal death audit reports for consistency. With the error threshold set at 5%, ≥ 17 correctly matched diagnoses in a sample of 20 deaths would make the lot accurate for COD diagnosis. Completeness of COD data was measured by calculating the proportion of IND that had death certificates completed.ResultsNineteen out of 52 eligible (36.5%) lots had accurate COD diagnoses recorded in their A&D registers. The regional distribution of lots with accurate COD data is as follows: Ashanti (4, 21.2%), Brong Ahafo (7, 36.8%), Eastern (4, 21.1%) and Volta (4, 21.1%). Majority (9, 47.4%) of lots with accurate data were from 2016, followed by 2015 and 2017 with four (21.1%) lots. Two (10.5%) lots had accurate COD data in 2014. Only 22% (239/1040) of sampled IND had completed death certificates.ConclusionDeath certificates were not reliably completed for IND in a sample of health facilities in Ghana from 2014 through 2017. The accuracy of cause-specific mortality data recorded in A&D registers was also below the desired target. Thus, recorded IND data in public sector health facilities in Ghana are not valid enough for decision-making or planning. Periodic data quality assessments can determine the magnitude of the data quality concerns and guide site-specific improvements in mortality data management.

Project description:BACKGROUND:The National Neonatal Research Database (NNRD) is a rich repository of pre-defined clinical data extracted at regular intervals from point-of-care, clinician-entered electronic patient records on all admissions to National Health Service neonatal units in England, Wales, and Scotland. We describe population coverage for England and assess data completeness and accuracy. METHODS:We determined population coverage of the NNRD in 2008-2014 through comparison with data on live births in England from the Office for National Statistics. We determined the completeness of seven data items on the NNRD. We assessed the accuracy of 44 data items (16 patient characteristics, 17 processes, 11 clinical outcomes) for infants enrolled in the multi-centre randomised controlled trial, Probiotics in Preterm Study (PiPs). We compared NNRD to PiPs data, the gold standard, and calculated discordancy rates using predefined criteria, and sensitivity, specificity and positive predictive values (PPV) of binary outcomes. RESULTS:The NNRD holds complete population data for England for infants born alive from 25+0 to 31+6 (completed weeks) of gestation; and 70% and 90% for those born at 23 and 24 weeks respectively. Completeness of patient characteristics was over 90%. Data were linked for 2257 episodes of care received by 1258 of the 1310 babies recruited to PiPs. Discordancy rates were <5% for 13/16 patient characteristics (exceptions: mode of delivery 8.7%; maternal ethnicity 10.2%, Lower layer Super Output Area 16.5%); <5% for 9/16 processes (exceptions: medical treatment for Patent ductus arteriosus 6.1%, high-dependency days 10.2%, central line days 11.2%, type of first milk 22.3%; and during first 14 days, summary of types of milk 13.8%; number of days of antibiotics 9.0%; whether antacid given 5.1%); and <5% for 10/11 clinical outcomes (exception: Bronchopulmonary dysplasia, defined as oxygen dependency at 36 weeks postmenstrual age 3.3%). The specificity of NNRD data was >85% for all outcomes; sensitivity ranged from 50-100%; PPV ranged from 58.8 (95% CI 40.8-75.4%) for porencephalic cyst to 99.7 (95% CI 99.2, 99.9%) for survival to discharge. CONCLUSIONS:The completeness and quality of data held in the NNRD is high, providing assurance in relation to use for multiple purposes, including national audit, health service evaluations, quality improvement, and research.

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A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data.

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A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data.

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