NHS Digital Data Release Register - reformatted

The Newcastle Upon Tyne Hospitals NHS Foundation Trust projects

• The Newcastle upon Tyne Hospitals NHS FT - Quarterly HES & ONS extracts (2019/20 application)

159 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

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The Newcastle upon Tyne Hospitals NHS FT - Quarterly HES & ONS extracts (2019/20 application) — DARS-NIC-170211-Z1B4J

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - data flow is not identifiable, Anonymised - ICO Code Compliant, No (Does not include the flow of confidential data)

Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Section 42(4) of the Statistics and Registration Service Act (2007) as amended by section 287 of the Health and Social Care Act (2012), Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii), Health and Social Care Act 2012 – s261(2)(b)(ii), Health and Social Care Act 2012 - s261 - 'Other dissemination of information', Health and Social Care Act 2012 - s261(5)(d), Health and Social Care Act 2012 – s261(2)(a)

Purposes: Yes (NHS Trust)

Sensitive: Non Sensitive, and Sensitive, and Non-Sensitive

When:DSA runs 2019-07-15 — 2020-07-14 2018.06 — 2024.03.

Access method: Ongoing, One-Off

Data-controller type: THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

1. Hospital Episode Statistics Admitted Patient Care
2. Hospital Episode Statistics Accident and Emergency
3. Hospital Episode Statistics Outpatients
4. Hospital Episode Statistics Critical Care
5. Civil Registration - Deaths
6. HES:Civil Registration (Deaths) bridge
7. Emergency Care Data Set (ECDS)
8. Civil Registration (Deaths) - Secondary Care Cut
9. HES-ID to MPS-ID HES Admitted Patient Care
10. HES-ID to MPS-ID HES Outpatients
11. Civil Registrations of Death - Secondary Care Cut
12. Hospital Episode Statistics Accident and Emergency (HES A and E)
13. Hospital Episode Statistics Admitted Patient Care (HES APC)
14. Hospital Episode Statistics Critical Care (HES Critical Care)
15. Hospital Episode Statistics Outpatients (HES OP)

Objectives:

The Newcastle upon Tyne Hospitals NHS Foundation Trust (NUTH) is the country's top performing trust for the number of research studies it has supported, with 528 studies delivered by the trust in 2016/17. NUTH has retained its position at the top of the NIHR Activity Research League Table for 6 years running. Northern Medical Physics and Clinical Engineering (NMPCE) is a Clinical Directorate within NUTH, with research interests and a track record going back almost 40 years in the development and evaluation of health technology interventions including medical devices, diagnostics and interventional procedures.
NMPCE will use Hospital Episode Statistics (HES) data to support its programme of research into outcomes of novel medical technologies and interventional procedures. This is a non-for-profit research programme which uses large pseudonymised data sets to assess peri-procedural, short-term and long-term safety and efficacy. The outputs of the programme are research publications, in open-access format wherever possible, which are intended to inform national guidance and decision-making.
The programme of outcomes research using administrative and registry data currently has funding from the NIHR and NICE. NMPCE has a track record of attracting research funding, and intend to seek future funding for their outcomes research programme, from public funding bodies, charities and organisations such as:
- NIHR projects (Invention for Innovation (i4i), Research for Patient Benefit (RfPB), Health Technology Assessment), Research Capability Funding, Newcastle Biomedical Research Centre;
- NIHR infrastructure funding (NIHR Newcastle Medtech and IVD Co-operative, NIHR Innovation Observatory);
- NICE (the External Assessment Centre, EAC, described below);
- Academic Health Science Network (AHSN) (North East and North Cumbria);
- Engineering and Physical Sciences Research Council (EPSRC);
- Charitable funding (Wellcome Trust, Innovate UK, British Heart Foundation, Newcastle Healthcare Charity);
- Professional societies supporting registry development;
- Commercial companies, which could include medical devices and diagnostics manufacturers.
NUTH was formerly an HSCIC / NHS Digital approved HES Business Objects (HESBO) and HES Data Interrogation System (HDIS) user. The NMPCE analysts within NUTH are trained and were approved to process episode level pseudonymised HES data for the research purposes described in this DARS application, for NHS Health and Social Care system, patient and public benefit. However, in consultation with NHS Digital, NUTH has concluded that the technical differences between the new HDIS2 and predecessor HDIS systems will prevent NMPCE analysts from conducting their established and published pseudonymised HES data analysis methods. This DARS application is therefore for a regular managed extract service of pseudonymised HES data from NHS Digital, which will permit NMPCE to recommence HES analysis, for the described research objectives.
Additional objective for processing mortality data sourced from civil registration data, by the NICE External Assessment Centre within NMPCE:
Since 2011, NUTH has hosted one of three current National Institute for Health and Care Excellence (NICE) External Assessment Centres (EAC). The NICE EAC is based in the NMPCE Directorate at the Freeman Hospital in Newcastle. The work commissioned by NICE evaluates medical device and interventional procedures and answers specific research questions raised by the NICE Medical Technologies Advisory Committee (MTAC), Diagnostics Advisory Committee (DAC), Interventional Procedures Advisory Committee (IPAC) and other NICE programmes.
NMPCE analysts will conduct HES analysis for NICE, as part of the outcomes research described in this DARS application. In addition, NICE has provided a commissioner letter for the External Assessment Centre within NMPCE as the legal basis for the pseudonymised mortality data requested in this application. Mortality data will only be processed by the named Approved Users and only for specific NICE-commissioned purposes. Mortality data will not be accessed for any other NMPCE (non-NICE) objectives.
Pseudonymised data from the HES datasets are required by NMPCE for the following purposes / activities:
1) to determine the number of patients with a particular disease attending an NHS hospital setting, the number being treated with healthcare interventions across England and identification of key providers of care, (e.g. to inform NICE of scope/coverage/uptake of guidance, to inform sample size determination and study invitations to organisations, for example NMPCE's cross-sectional Recurrent Respiratory Papillomatosis survey which determined the number of patients with the condition, the proportion receiving hospital treatment and the breakdown of interventions used in this population Donne et al. Clinical Otolaryngology 2016. This work led to successful NIHR Research for patient benefit grant funding),
2) to determine patient demographics receiving healthcare interventions (e.g. common comorbidities, comorbidity score index, age distribution, gender),
3) to determine in-hospital outcomes (e.g. efficacy and safety) of health care interventions,
4) to conduct longitudinal analysis to determine long-term outcomes (e.g. efficacy, safety and in-hospital mortality) of healthcare interventions (e.g. 8 year analysis of almost 100,000 women with surgical insertion of mesh implants for the treatment of stress urinary incontinence, Keltie et al. Scientific Reports. 2017). The retention of HES data up to a maximum of 20 years will permit further, longer term follow-up analyses of these women, to establish the as-yet unknown longevity of mesh implants and any change in efficacy and complication rates as they age,
5) to compare patient outcomes (including in-hospital and longitudinal outcomes) between healthcare interventions (e.g. through propensity matching of cohorts based on comorbidities) to determine relative efficacy and safety. The retention of HES data up to a maximum of 20 years will permit future analyses of paediatric RRP patients in the AIR registry, to determine which treatments have enduring efficacy outcomes into adulthood, i.e. the age at which RRP prevalence typically falls.
6) to determine hospital resource usage prior to and following healthcare interventions (e.g. number and indication of outpatient attendances, subsequent hospital admission, further interventions, accident and emergency attendances for a given HESID, in-hospital deaths), for example in the published study of procedural and short-term efficacy of bronchial thermoplasty (Burn et al., 2016): https://www.tandfonline.com/doi/full/10.1080/02770903.2016.1263652,
7) to determine national coverage of and encourage data submission to national clinical or procedural registries (e.g. identification of trusts not contributing data to registries, data completeness of registry in terms of total number of procedures not recorded in registry, data completeness of registry in terms of complications reported using anonymised matching techniques based on for example treating trust, sex, procedure date, gender, age datafields), for example, active surveillance undertaken for the Airway Intervention Registry, using the former HDIS system.
8) to complement national registry data collection to achieve richer information than can be achieved from a single data set (using anonymised matching technique based on for example treating trust, sex, procedure date, gender, age datafields), as described in more detail in section 5b), below,
9) to conduct exploratory analysis to determine whether outcomes (e.g. complications, in-hospital death) are associated with patient characteristics or setting (e.g. published analysis of hospital centre volume on iliac artery stenting outcomes).
The most significant issue with the use of HES data alone in healthcare outcomes research is missing information on out-of-hospital deaths (date and cause of death). This risks overestimating the efficacy and safety of medical devices and interventional procedures in the aggregated results reported to NICE by NMPCE, to inform national NICE Guidance. Hence, in addition to the above nine NMPCE purposes / activities, pseudonymised mortality data are required by NMPCE for the following NICE-funded purposes / activities:
10) to add to the above longitudinal analysis in 4), to determine the long-term outcome of all-cause mortality, requiring both in-hospital (HES) and out-of-hospital (ONS) mortality data of healthcare interventions,
11) to add out-of-hospital mortality data to 5) above, in comparative patient outcomes analysis,
12) to add out-of-hospital mortality data to 6) above, in analysing hospital resource usage prior to and following healthcare interventions
13) to add out-of-hospital mortality data to 8) above, to complement national registry data collection to achieve richer information than can be achieved from a single data set (using anonymised matching technique based on for example treating trust, sex, procedure date, gender, age datafields),
14) to add out-of-hospital mortality data to 9) above, to conduct exploratory analysis to determine whether outcomes, including out-of-hospital deaths, are associated with patient characteristics or setting (e.g. age, gender, treating hospital).
HES and mortality data will not be used for any commercial purposes. These data will not be provided in record level form to any third party. These data will not be used for direct marketing. NUTH determines which data are processed for each project/research question and ensures the legal basis for requesting, storing and processing these data are met, therefore NUTH is the sole Data Controller and sole Data Processor.

Yielded Benefits:

Examples of peer-reviewed publications (available in the public domain) resulting from the analysis of HES data previously accessed via HDIS by NMPCE for NICE purposes, with details of the impact these have achieved are as follows: 1) Keltie et al. Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women. Sci Rep. 2017; 7(1): 12015. IMPACT: Complications from surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. This was one of the largest studies so far looking at adverse event rates of these procedures, and has significantly added to the understanding of the likelihood of adverse events from mesh procedures in a UK NHS setting. This means that women considering mesh procedures in future will have more accurate safety information available to them, so they can make a more informed choice. This publication and its analysis code was published in an open-access form to share both methodology and findings widely. 2) Burn et al. Procedural and short-term safety of bronchial thermoplasty in clinical practice: evidence from a national registry and Hospital Episode Statistics. J Asthma. 2017; 54(8): 872-879. IMPACT: Bronchial thermoplasty is a novel treatment for severe asthma, however its mode of action and target patient population were poorly defined, with little evidence available on efficacy and safety in terms of quality and quantity. This study presents procedural and short-term safety evidence from routine UK clinical practice. 3) Donne et al. Prevalence and management of recurrent respiratory papillomatosis (RRP) in the UK: cross-sectional study. Clinical Otolaryngology. 2017; 42(1):86-91. IMPACT: Recurrent respiratory papillomatosis is a relatively rare condition, but has a significant impact on patients and their families as it requires repeated anaesthetic procedures to achieve symptomatic control. This study utilized a cross-sectional survey of ENT consultants and analysis of HES data to provide, for the first time, an estimate for the prevalence of recurrent respiratory papillomatosis in the UK. This prevalence informed the sample size for an NIHR Research for Patient Benefit grant application - 3 year award granted. Identification of key providers of RRP care in the UK, enabled NMPCE to invite specific acute trusts to contribute to further research in RRP patients, and contribute to future NICE guidance (in update of IPG 434). 4) Goode et al. Effect of procedure volume on outcomes after iliac artery angioplasty and stenting. British Journal of Surgery. 2013; 100:1189-1196. IMPACT: This study was able to use HES data to determine if there was an association between outcomes of endovascular iliac artery intervention and centre volume, describing methodology which could be applied to any interventional in-hospital procedure which would benefit future analysis of HES data. 5) Patrick et al. Monitoring the use and outcomes of new devices and procedures: how does coding affect what Hospital Episode Statistics contribute? Lessons from 12 emerging procedures 2006-10. Journal of Public Health. 2012; 35(1): 132-138. IMPACT: This study provided evidence that routinely collected HES data have the potential to support quality improvements and evidence-based commissioning of devices and procedures in the national health service. 6) Keltie K, Cole H, Arber M, Patrick H, Powell J, Campbell B, Sims AJ. Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes. BMC Medical Research Methodology 2014; 14:126. IMPACT: This study summarized methods of analyzing complications of interventional procedures from routine healthcare databases in the UK published in the literature. This study was published in open-access form to share learnings with other researchers and clinical coding teams across the UK to encourage high quality research from HES.

Expected Benefits:

1) Contributing to national policy (e.g. new/updated Medical Technologies and Interventional Procedures guidance issued nationally by NICE).
2) Adding to the evidence base for specific medical device interventions/interventional procedures to inform patients (e.g. via study websites, NMPCE department website, presentation to relevant patient and public involvement groups to ensure that information is reaching the public in an appropriate format and in plain language which will vary by study population, in line with NIHR National Standard for Public Involvement), as well as health care providers and professional societies (e.g. via open access peer-reviewed publications, conference presentations/posters, regular newsletters to clinicians contributing to clinical registries) of the efficacy and safety of specific medical device interventions/interventional procedures.
3) Improving uptake (active surveillance of key providers in HES) and data completeness (complementary nature of administrative data captured in HES/ONS) of dedicated health registries providing richer information/evidence for specific medical device interventions/interventional procedures.
4) Disseminating open-access peer-reviewed publications describing coverage and hospital resource usage associated with specific medical device interventions/interventional procedures to inform local commissioners.
5) Disseminating open-access peer-reviewed publications describing methodology used (including transparent publication of analysis code where used) to assist future researchers using HES data and to provide feedback to clinical coders to inform them of how coded administrative data submitted to HES is used which in turn improves clinical coding accuracy.
6) Disseminating information in public domain (e.g. patient summaries, study websites e.g. http://www.rrp.org.uk/) to better inform patients, parents/guardians/carers, clinicians and healthcare providers of ongoing study progress, interim/completed research findings, key providers of specific medical device interventions/interventional procedures. For example, the RRP extension to the Airway Intervention Registry was selected as one of the 4 best projects presented to the Young Person’s Advisory Group North England (YPAG NE) in 2015-16 and was invited and disseminated further by presentation at their annual conference in 2016: https://www.eventbrite.co.uk/e/young-peoples-voices-shaping-the-future-of-research-and-healthcare-registration-27623905846. NMPCE staff are scheduled to continue PPI activities with the YPAG NE throughout the duration of the NIHR RfPB grant-funded study of RRP.
7) Directing further research (in support of grant funding applications) in determining sample size populations, and key providers.

Outputs:

In general, NMPCE will produce an output in the form of a publication outlining an individual project's findings which, subject to acceptance, will be published in peer-reviewed academic or clinical journals. Additional outputs include grant application to funding bodies, conference presentations, summaries shared with public/patient representative groups and summaries shared on dedicated study websites (where applicable). All outputs will contain only data that are aggregated with small numbers suppressed, in line with the HES analysis guide. Pseudonymised episode level HES data extracts sent to NMPCE from NHS Digital will not be shared externally. NMPCE strives to make all peer-reviewed publications available in open access form in order to maximize the distribution of information to health care users, health care providers and general members of the public. The exact journal of any peer-reviewed publication will depend on the medical device intervention/interventional procedure of interest (e.g. cardiac, ENT, oncology) and focus of the research question posed (e.g. methodology, patient safety, national policy).

NMPCE engages with clinical coders in acute trusts across England prior to analysis of HES data, but also provides feedback to clinical coders to demonstrate the external uses of coded hospital data, with the aim to continually improve data quality at source. All publications using HES/mortality data will reference NHS Digital and cite a copyright statement.

One specific NIHR-funded project in progress is the Research for Patient Benefit award PB-PG-0416-20037 - Airway Intervention Registry (AIR) extension - Recurrent Respiratory Papillomatosis (RRP). Recruitment of the study in England will be compared (via routine monthly surveillance) to the number of RRP procedures being reported to the Hospital Episode Statistics (HES). This will enable NMPCE to invite new NHS hospitals/trusts to contribute to the study and also contact registered NHS hospitals/trusts to encourage data entry where lacking. NMPCE have found that this method of feedback to NHS organisations (via Information Governance teams and clinical coding managers) has increased data entry to previous online databases as well as improving clinical coding accuracy for some interventional procedures.

For NICE purposes, NMPCE will share aggregated information with NICE, to contribute to the production of national Medical Technologies Guidance or Interventional Procedures Guidance, inform other NICE programmes, and thereby inform healthcare users, health care providers and commissioners of the safety and efficacy, national adoption and key providers of medical device interventions and interventional procedures. An output will be an internal report outlining an individual project's findings submitted to NICE with small number suppression in line with the HES analysis guide.

Target dates:
In general, NMPCE projects involving medical device intervention/interventional procedure development or evaluation arise with clinical need, with timeframes governed by suitable funding calls and duration of grant applications.

In the specific example of the NIHR-funded Airway Intervention Registry (AIR) extension - Recurrent Respiratory Papillomatosis (RRP) project, a rolling monthly extract from the AIR will be compared with the latest quarterly HES extract from NHS Digital in active surveillance of coverage of the registry (total number of RRP cases treated in England versus total number entered in the registry). The target date for recruitment completion is August 2020.

In the specific case of NMPCE projects addressing NICE purposes, NICE commissions a rolling programme of work, with each individual project issued with various target dates of completion. NMPCE work for NICE purposes produces peer-reviewed publication of results within 12 months of project completion and strives to share analysis code (where possible and journal permitting) for transparency and reproducibility purposes for future researchers.

Examples of outputs that have already been published in peer-reviewed journals, with details of the impact achieved through each output, can be found in the Yielded Benefits section.
Examples of internal reports submitted to NICE/ applications to grant funding bodies, can also be found in the Yielded Benefits section.
NICE will consider evidence generated from NMPCE through its analysis of HES/mortality data for NICE purposes in order to update the following Interventional Procedures Guidance (all currently require update):
1) NICE IPG419: Bronchial thermoplasty for severe asthma (originally published January 2012 - update required)
2) NICE IPG425: Endoscopic balloon dilatation for subglottic or tracheal stenosis (published April 2012 - update required)
3) NICE IPG434: Radiofrequency cold ablation for respiratory papillomatosis (published November 2012 - update required).
4) NICE IPG309: Percutaneous mitral valve leaflet repair for mitral regurgitation (published August 2009 - update required).

Processing:

Processing:
Pseudonymised HES and mortality data extracts received from NHS Digital will only be accessed by authorized NMPCE staff. A register of HES and ONS analysts will be kept and updated by the NUTH Information Asset Owner as per the NMPCE department Protocol on “Management of HES data”. NUTH will be sole Data Controller and the only organisation processing data received from NHS Digital.

In instances where NICE commissions a project with an established national registry collecting clinical or procedural information, NMPCE analysts will use HES/mortality data to complement national registry data collection to achieve richer information than can be achieved from a single data set (evidence for use of HES data for this purpose is found in the publication Patrick et al., Journal of Public Health 2013; Keltie et al., BMC Medical Research Methodology 2014). NMPCE analysts would gain a pseudonymised extract from the specialist registry and combine with the pseudonymised episode-level data from HES/mortality data and use an anonymised matching technique based on treating trust, sex, procedure date, gender, age in order to determine if safety events and outcomes were reported accurately in the registry. NMPCE analysts would also conduct capture-recapture analysis (Hook & Regal, Epidemiol Rev 1995) to obtain the maximum likelihood estimate of the true number of procedures undertaken in England and an estimated coverage for each data source (specific registry and HES). NMPCE (for NICE purposes) has previously published the complementary nature of HES data alongside information gathered by specialist registries (Burn et al, Journal of Asthma 2016). NMPCE analysts have found that providing feedback to users of both datasets (e.g. clinical coders, treating clinicians, researchers) is likely to improve data completeness and data quality of both datasets.

Data linkage of HES and mortality data conducted by NMPCE to anonymised extracts from clinical registries will only include anonymised matching techniques as permitted by this application. No additional data linkage will be conducted. There will be no requirement nor attempt to re-identify individuals from the data. All processing of mortality data will be in line with ONS standard conditions.

NMPCE works closely with clinical coding managers from several acute trusts in England, who have previously advised on appropriate diagnosis (ICD) and procedure (OPCS) codes which can be used to identify a particular medical device intervention/interventional procedure (evidence for use of HES data for this purpose is found in the publication Donne et al., Clinical Otolaryngology 2016; Keltie et al., Scientific reports 2017). R programming language is routinely used for loading, cleaning, processing and statistical analysis of HES/mortality data. NMPCE actively tries to publish all analysis code (using R programming language) in the interests of transparency and reproducibility so that other researchers can gain from our experience (Keltie et al, Scientific Reports 2017).

Storage: All data received from NHS Digital will be stored on NUTH premises, securely within the NUTH IT network which, has access protected in accordance with the NUTH “Network Security & Access Control Policy”. The server and back-up server are sited locally within the Freeman Hospital grounds. Access to the server room requires special permission, as it has its own access restrictions. Data are backed up to tape, which is held in a secure area in a different fire zone in the Freeman Hospital Grounds.

Data minimization:
The data fields requested from each data set (mortality, HES APC, OP, A&E, CC) have been minimised. As a previous HESBO and HDIS user, NMPCE has used a specific subset of HES and ONS data fields to inform evaluations of safety and efficacy for given healthcare interventions. For example: admission and discharge information, all diagnoses and procedure codes (4 character), episode and spell information (to build up an entire patient admission), treating organization, referring organization, patient age and sex. Date of death is restricted to month and year of death (mm/yyyy) which is required (from ONS) for Kaplan-Meier statistics (giving risk at specific point in time with confidence intervals), which is used to determine the safety/risk profile for a medical device or interventional procedure. Month and year of death also assists in internal data cleaning processes (i.e. to ensure no HES episodes appear for a given PSEUDO_HESID after a month of death).

National data are required due to the breadth of healthcare intervention (medical devices, diagnostics, interventional procedures) development and evaluation conducted (i.e. any condition, any procedure, any population). Access to HES data for the whole of England is also particularly important for NMPCE when considering interventions on rare diseases. Furthermore, by using data from across the whole of England (rather than a specific localized region), NMPCE can assure that outcomes are generalizable and reflect current practices used across the country in order to inform national NICE Guidance. In order for NMPCE to conduct activities for NICE purposes, some of the “Objectives for processing” (described in the previous section) require access to HES/mortality data from all England (mortality data will only be used by NMPCE for NICE purposes, not for wider outcomes research within NMPCE).

No identifiable information is requested. NMPCE requires only a unique patient pseudonym (e.g. PSEUDO_HESID or ENCRYPTED_HESID) that links across each data set (ONS, HES APC, OP, A&E, CC) to determine hospital resource usage and long-term outcomes for each patient.

Minimisation based on years of data has been applied. Ten years of historical HES APC data (to replicate and potentially add longer term follow-up to previously published work , see the ‘Yielded Benefits’ section) and five years historical HES OP, A&E, CC data are requested to allow identification of pre-intervention comorbidities and prior admissions (evidence of the use of HES data for this purpose is described in the publication Mamidanna et al. Ann Surg. 2012; 255: 197-203) and to compare hospital resource usage before and after a medical device intervention/interventional procedure (evidence for use of HES data for this purpose is described in the publication Kulkarni et al. Surgeon. 2011; 9(1): 18-21). Quarterly extracts of HES data are requested going forward, to ensure safety signals for medical device interventions/interventional procedures are detected in a timely manner (this is particularly important when evaluating for example novel medical device interventions/interventional procedures where safety evidence is lacking). Receiving quarterly extracts from HES also ensures data completeness and data quality monitoring of national clinical or procedural registries on an ongoing basis, enabling timely feedback to registry users/registry funders.

The amount of mortality data requested has also been minimized by restricting by year to only those patients which have been admitted to inpatients (from 2007/08 onwards), or attended outpatients, accident & emergency, or critical care departments (from 2013/14 onwards). The frequency of mortality data requested is restricted to quarterly, to ensure safety signals are detected in a timely manner.

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