Concerns raised 8 Use of trial operators with limited on-site availability and experience View source Insufficient time for trial information review and informed consent before procedures View source Inaccurate terminology about the cause of procedural injury View source Failure to communicate trial involvement and suspected trial-related events to receiving clinicians View source Failure to ensure adequate information for trial clinicians View source Failure to notify the Coroner of a trial patient's death and trial involvement View source Conduct of trial procedures under competing time pressure View source Failure to record suspected trial-related causes in hospital notes View source See 5 more concerns
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AI-generated summary
John Henry ADAMS · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
John Henry Adams died following multiple complications of an appropriate cardiac intervention after being recruited to a cardiac trial just before the procedure. Concerns included whether there was sufficient time for informed consent, the suitability and preparedness of the trial operator, and the recording and communication of the trial’s possible relevance to the cardiac tamponade and subsequent death.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Use of trial operators with limited on-site availability and experience
Wider context from the report “(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every fortnight to be the "operator" to take part in this trial ?
(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately informed?
In evidence I was told that he was already late for a Clinic when he left the Hospital, believing that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer than normal - possibly about half an hour longer.
Does that sort of pressure result in the best outcome?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Insufficient time for trial information review and informed consent before procedures
Wider context from the report “(2) Was it appropriate that he should have been recruited within an hour or so prior to his procedure commencing ?
(3) Did this give him time to read the several page booklet which was provided to him and to absorb the information and give informed consent?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Inaccurate terminology about the cause of procedural injury
Wider context from the report “(7) The hospital notes in Brighton, the letter of referral to Kings College Hospital and the report to the Coroner all gave the impression, because of the wording used, that what had happened at the PCI was that the diagonal artery had dissected and this is what is believed to have caused the pericardial effusion and tamponade.
The Consultant Cardiologist is the only person to have used the expression "dissection" to describe the damage to the diagonal artery which occurred during the PCI.
Should more care be taken in terminology? In this case it seems to have lead to a great deal of confusion.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Failure to communicate trial involvement and suspected trial-related events to receiving clinicians
Wider context from the report “(8) One of the organisers of the Trial has written in Mr. Adams' notes that he has been notified of what has happened to Mr. Adams but he makes no mention of what is believed to have occurred as a result of the Trial . Why not?
Why was the Trial not mentioned to Kings College Hospital in the Referral letter dated the 1st February 2014?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure adequate information for trial clinicians
Wider context from the report “(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every fortnight to be the "operator" to take part in this trial?
(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately informed?
In evidence I was told that he was already late for a Clinic when he left the Hospital, believing that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer than normal - possibly about half an hour longer.
Does that sort of pressure result in the best outcome?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Failure to notify the Coroner of a trial patient's death and trial involvement
Wider context from the report “(9) Finally; surely the death of a patient while on a Trial is a matter of major concern to the Trial itself and yet no-one contacted the Coroner , either the original Coroner in South London or me, Coroner for Brighton and Hove when I took over jurisdiction pursuant to Section 2 of the Coroner’s and Justice Act, to let us know that this man had been on a Trial .
If I had known that, and in particular if I had been able to tell ████████ of that fact, she would have been able to ascertain precisely where the bleeding/haemorrhage originated and there would have been good clear helpful information for those managing the Trial and of course future patients who might have benefited from it.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Conduct of trial procedures under competing time pressure
Wider context from the report “(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every fortnight to be the "operator" to take part in this trial?
(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately informed?
In evidence I was told that he was already late for a Clinic when he left the Hospital , believing that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer than normal - possibly about half an hour longer .
Does that sort of pressure result in the best outcome?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Health Research Authority; that does not assign responsibility.
PFD Monitor interpretation Failure to record suspected trial-related causes in hospital notes
Wider context from the report “(6) The Hospital notes for Mr. Adams admission on the 30th do not mention the view (apparently formed within an hour or so of surgery), that it was the pacing wires; which was the extra requirement of the Trial; which caused the cardiac tamponade .
Why not? Why was this information effectively concealed?
” Open source report
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Addressed to: National Research Ethics Service.
Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations