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• Response to letter of 22/5/18
  Ken Dunn
  Published on: 29 October 2019
• Undisclosed conflicts of interest, data quality and interpretation issues with the international Burn Injury Database (iBid)
  Kayvan Shokrollahi, Baljit Dheansa and William Dickson
  Published on: 24 May 2018

• Published on: 29 October 2019

  Response to letter of 22/5/18

  • Ken Dunn, Burn Surgeon Manchester University NHS FT

  Dear Editor

  In response to the letter of 22 May, we are happy to deal with the key issues of conflict of interest, acknowledgement and data interpretation. However, many of the comments in the letter deal with the funding, function and nature of the NHS England contract for the database. We feel this is a matter that should be taken up with NHS England rather than the letter section of this Journal as it has little, if anything, to do with the paper as published.

  Regarding the issue of undeclared conflict of interest. Mr Dunn is a burn surgeon with an honorary position at Manchester University and was co-supervisor of the primary author’s PhD at Manchester University. The paper was reviewed by academic peers before publication and the source of funding for the associated PhD was declared. We have reviewed the Journal’s document on competing interests and are satisfied that we declared all interests relevant to the basis, process or conclusions of the work undertaken.

  The burn injury database is funded by NHS England and is managed as part of his NHS contract by Mr Dunn who is medical director of the iBID and co-chair of the Burn Care Informatics Board that oversees the use of the iBID data. It is this Board which sanctioned the release of the anonymized data on which this paper and the PhD work was based. In the paper the source of the data is mentioned and my control of this aspect inferred but I accept is not stated. Should the Editor feel an addendu...

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  Dear Editor

  In response to the letter of 22 May, we are happy to deal with the key issues of conflict of interest, acknowledgement and data interpretation. However, many of the comments in the letter deal with the funding, function and nature of the NHS England contract for the database. We feel this is a matter that should be taken up with NHS England rather than the letter section of this Journal as it has little, if anything, to do with the paper as published.

  Regarding the issue of undeclared conflict of interest. Mr Dunn is a burn surgeon with an honorary position at Manchester University and was co-supervisor of the primary author’s PhD at Manchester University. The paper was reviewed by academic peers before publication and the source of funding for the associated PhD was declared. We have reviewed the Journal’s document on competing interests and are satisfied that we declared all interests relevant to the basis, process or conclusions of the work undertaken.

  The burn injury database is funded by NHS England and is managed as part of his NHS contract by Mr Dunn who is medical director of the iBID and co-chair of the Burn Care Informatics Board that oversees the use of the iBID data. It is this Board which sanctioned the release of the anonymized data on which this paper and the PhD work was based. In the paper the source of the data is mentioned and my control of this aspect inferred but I accept is not stated. Should the Editor feel an addendum to the on-line paper is warranted to detail these facts, this would be straightforward.

  Regarding the issue of an acknowledgement of contributing services. For the purposes of brevity, we followed the examples of papers from other national registries in not listing all contributing services as this information is available elsewhere.

  Regarding the issues of data interpretation and the suggestion that there was insufficient discussion about the reasons for increased admissions, we should point out that almost half the Discussion section of the paper as well as part of the Limitations sections deal with the progressive uptake of the database in England and Wales, which may be the reason for increased numbers. It was also acknowledged that NHS Hospital Episode Statistics data also showed an increase in the numbers and that might be because of the changes implemented due to the National Burn Care Review recommendations published in 2001.

  Regarding data cleaning and completeness. It is specifically stated that data cleaning was undertaken before using any variable so as not to lose important information which might influence other variables.

  Regarding advocating a continued mandate for the use of iBID. We fail to see how we can be criticised for what we believe would be of benefit to patients and commissioners and any other stakeholder in the healthcare system.

  We hope this clarifies matters for the Editor and readership.

  Yours sincerely,

  Dr Neophytos Stylianou
  Prof Iain Buchan
  Mr Ken Dunn

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  Conflict of Interest:
  None declared.

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• Published on: 24 May 2018

  Undisclosed conflicts of interest, data quality and interpretation issues with the international Burn Injury Database (iBid)

  • Kayvan Shokrollahi, Consultant Plastic and Laser Surgeon Northern Burn Operational Delivery Network
  • Other Contributors:
    • Baljit Dheansa, Consultant Burns and Plastic Surgeon
    • William Dickson, Adult Clinical Lead

  Dear Editor,

  Having read the article by Stylianou, Buchan & Dunn [1] reviewing the International Burn Injury Database we have concerns regarding conflicts of interest, failure to acknowledge the contribution of burns services and also the interpretation of the data presented. The senior author failed to disclose that he has been directly involved in the development of the database, was involved in making it a mandatory part of burns care in England and is currently paid to manage it. In another online BMJ publication Injury Prevention [2], the same senior author gave his affiliation as: International Burn Injury Database, Burn Centre, Acute Block UHSM Southmoor Road, Manchester M23 9LT, UK. He is also chairman of the Burn Care Informatics Group which is supposed to oversee the development and use of iBID. We are unclear how the latter group can function with any independence when the chair of that group is also responsible for the running of the database itself and also authoring articles based on the entirety of that data. All burns services contribute to the database and this has required significant efforts at considerable cost to ensure that data is collected accurately and in a timely fashion. Without this contribution, iBID would have little data and acknowledging this would also have been appropriate.

  iBID is funded by the NHS with direct and indirect costs, none of which have ever been published or are easily available. The direct costs are noted...

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  Dear Editor,

  Having read the article by Stylianou, Buchan & Dunn [1] reviewing the International Burn Injury Database we have concerns regarding conflicts of interest, failure to acknowledge the contribution of burns services and also the interpretation of the data presented. The senior author failed to disclose that he has been directly involved in the development of the database, was involved in making it a mandatory part of burns care in England and is currently paid to manage it. In another online BMJ publication Injury Prevention [2], the same senior author gave his affiliation as: International Burn Injury Database, Burn Centre, Acute Block UHSM Southmoor Road, Manchester M23 9LT, UK. He is also chairman of the Burn Care Informatics Group which is supposed to oversee the development and use of iBID. We are unclear how the latter group can function with any independence when the chair of that group is also responsible for the running of the database itself and also authoring articles based on the entirety of that data. All burns services contribute to the database and this has required significant efforts at considerable cost to ensure that data is collected accurately and in a timely fashion. Without this contribution, iBID would have little data and acknowledging this would also have been appropriate.

  iBID is funded by the NHS with direct and indirect costs, none of which have ever been published or are easily available. The direct costs are noted in official documents in our possession to be around £275,000 of which a portion is allocated to wages including the senior author via sessions remunerated from iBid funds administered by the hosting Manchester NHS service. In order to be transparent, we feel it is important for readers to be aware of this, especially when one of the conclusions of the paper is that iBid should be mandatory. The indirect costs are likely to be considerably more because every burns service requires data input clerks for the sole purpose of mandatory iBid data entry, and all members of the multidisciplinary team to contribute to data acquisition. Whilst staff costs are therefore difficult to fully define as the time given by all staff is difficult to measure, and because none of these figures have been published, we can estimate the indirect costs of data entry. Using figures from our own services and translating them across all services, a conservative estimate is £15,000 per year per burns service to employ data clerks which translates to an estimate of indirect costs of be £545,000 but likely to be much more. We would welcome a piece of work that finally publishes the exact figures for direct and indirect costs at a time of funding concerns, as well as published annual accounts capturing all the costs as we all need to be clear about the tangible benefits of such an investment. Costs of running any database can be high but for a relatively small specialty we therefore estimate at least £820,000 a year is spent on acquiring data which translates to £7.3 million for the time-period during which the data upon which this paper relies was collected. Importantly, these costs were born by all burns services across the country who subsequently had no input into the authorship of the paper in question, and in our view are likely to have made different conclusions to those made by the authors.

  Data of this kind should be of use to commissioners and clinicians alike, but the presentation of such data raises concerns, especially when some data translates into dashboards upon which service performance is judged and comparisons made. The conclusion made by the authors that there has been up to a threefold increase in burns activity is dangerously inappropriate when one considers the introduction of any database. Although they acknowledge that slow uptake and increased data entry of non-admitted burns has contributed to the rise in their discussion, we feel that there are many flaws in the way that they have presented their results. Suggesting that a rapid rise of data records is coincident with increased clinical activity when a new mandatory database has been introduced is not the most likely cause. Our own experience is reflected by others who note that the introduction of a new process was challenging and took one or more years to fully integrate. This may also have an impact on geographical locations of burns, as services which have been using the database longest may end up recording higher numbers. A number of other conclusions such as "The [Trust] with the highest workload [in the UK is] the Manchester Teaching PCT" (to which the authors are affiliated and which hosts the database) are also deeply flawed, especially as commissioning decisions might well be made based on such conclusions.

  The authors report "admissions" and "workload" but fail to identify one of the major concerns with iBID: there are no clear definitions in iBID relating to any of the common data points resulting in significant variations in what is recorded. This means that one service can record an admission while exactly the same patient may be recorded as an out-patient as each service defines an admission differently. This is also the case for many other data fields meaning that comparison between services is not easily possible. Furthermore, each service may choose to only record burns which are admitted rather than all of the cases referred to the service. This variation in recording types of cases may also skew any interpretation of geographical variation. The authors also briefly mention data cleaning and data completeness. We have concerns that they do not clearly define what they mean by data cleaning as this may significantly alter the output of any database. Again, data completeness may have a significant impact on any output depending on what limits are applied when developing a report. Even if the database adapts and improves in future, or has started to do so, this will not affect or improve all previous years of data upon which the conclusions of this paper have relied.

  These points have been raised by the burns community for several years and up until recently we did not have access to the way data fields were used to produce reports to ensure that they could be reproduced by others. These concerns still remain. This is exampled by some data generated by iBid relating to inhalation injury where there seems to be a cohort of patients not admitted to hospital, yet who sustained moderate or severe inhalation injury (requiring mechanical ventilation) - which in practice is clearly not compatible. Concerns have also been raised within the NHS regarding various aspects of iBID including its ability to provide reliable and useful data [2]. These concerns have led to the decision by the National ODN Group* (of which we are current or past members) representing all four Burn Networks not to use national iBid data reports for the National Burns Mortality Audit.

  The authors believe that iBID should only continue as a mandatory database if the concerns raised and the limitations expressed have been fully addressed through an independent process that allows complete transparency with regards to governance and data quality ensuring that those who are directly involved with the database have no conflicts of interest. 21st century medicine often quotes the benefits of data but without ensuring that the quality of reports from such data are able to have a direct impact on care we advise caution. We would encourage the authors to share their raw data as promised in their initial paper to allow others to try and reproduce their reports and also to take a more balanced interpretation of the data they present as well as present a more comprehensive view of the limitations of their work.

  We also note that the declared source of funding for this project was stated to be the Margaret Miller Fund, which we understand to be restricted funds for the sole purpose of ‘research into methods of preventing burn injuries in the home’, and to which this research does not appear to relate.

  References:

  1. Neophytos Stylianou, Iain Buchan, Ken W Dunn. A review of the international Burn Injury Database (iBID) for England and Wales: descriptive analysis of burn injuries 2003–2011.

  2. K Dunn. The epidemiology and continued monitoring of burn injury in England and Wales. P Safety 2010 abstracts. Injury Prevention 2010;16(Suppl 1):A1–A289. DOi: 10.1136/ip.2010.029215.753

  3. Informing the future procurement of the International Burn Injury Database (iBID) HQIP 2011.

  Keywords: iBid, database, data, burns, conflicts of interest, audit

  Affiliations, Statements and Disclosures:

  At the time of writing

  Kayvan Shokrollahi FRCS(Plast) LLM is the Clinical Lead for the Northern Burn Operational Delivery Network*, NHS England; Clinical Lead for the Mersey Regional Burns Service; Vice-Chairman of the Charity The Katie Piper Foundation; Editor-in-Chief of the Journal Scars Burns & Healing; Associate Editor of the Journal Annals of Plastic Surgery; Chairman of the Communications Subcommittee of the British Burn Association.

  Baljit Dheansa FRCS(Plast) has recently stepped down as the Clinical Lead for the South East of England Burn Operational Delivery Network*, NHS England and is Lead for Burns at Queen Victoria Hospital East Grinstead.

  William Dickson MBE FRCS(Glas) FRCS (Eng) is the Adult Clinical Lead for the South West UK Burn Operational Delivery Network*, NHS England, and formerly Director of the Welsh Burns Centre, Morriston Hospital, Swansea.

  *There are 4 burn networks covering the whole of England comprising North, Midlands, South East and South West operational delivery networks (ODNs). The Managers and Clinical Leads of each plus commissioners constitute the National ODN group.

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  Conflict of Interest:
  None declared.

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