Recurring concern

Failure to ensure clinical treatment approaches are supported by adequate evidence

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First reported 4 Mar 2014•Latest report 17 May 2024

Definition

What this concern includes

Includes failures to establish, review or document an adequate published evidential basis for a clinical treatment approach, including novel treatments lacking professional support and commonly used procedures whose material risks have not been sufficiently quantified.

Not included

Excludes generic failures to follow clinical guidance where the concern is not the absence or inadequacy of evidence supporting the treatment approach.
Excludes non-clinical policies, public guidance or regulatory mechanisms unless the assertion directly concerns the evidential basis for a clinical treatment approach.
Excludes failures limited to treatment delivery, consent, documentation or clinical communication when the treatment approach itself has an adequate evidential basis.
Excludes unsupported claims about outcomes or harm where no deficiency in the evidence or risk justification for the treatment approach is identified.

Reports: 4
Individual concerns: 4
Date range: 2014–2024
Stated actions: 3

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Care Quality Commission2

Royal College of Radiologists2

Avon and Wiltshire Mental Health Partnership NHS Trust1

Circle Health Group Limited1

East Lancashire Hospitals NHS Trust1

General Medical Council1

Mid Yorkshire Teaching NHS Trust1

Mother of the deceased1

Royal Surrey County Hospital1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

17 May2024
Lancashire and Blackburn with Darwen
Concerns raised1
1. Use of inappropriate research providing false reassurance about suprapubic catheter risks in patients with lower abdominal surgery
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.

No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

Antony Waring · 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

Antony Waring died on 24 June 2020 after a suprapubic catheter insertion perforated two loops of small bowel, leading to peritonitis, intensive care admission and subsequent death. The concerns included delays in introducing a standard operating procedure, the proposed use of CT scanning rather than ultrasound, inadequate ultrasound training, chance-based allocation of high-risk patients, and inappropriate research about complication risks.

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.
PFD Monitor interpretation
Use of inappropriate research providing false reassurance about suprapubic catheter risks in patients with lower abdominal surgery
Wider context from the report
“(5) The expert evidence at the inquest was that the research provided on the risk of complications after insertion of a suprapubic catheter into patients with lower abdominal surgery is inappropriate the patient such as Antony Waring and provides false reassurance as to the level of risk posed to these patients. ”
Source location
Antony Waring · Prevention of Future Deaths report
Page 3 · concerns
Open source report
1 Dec2023
West Yorkshire Eastern
Concerns raised1
1. Lack of quantified published evidence on ascitic tap risks
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions 2
1. Position
  Existing national guidance adequately reflects the established risks of ascitic drainage, supported by standard ultrasound guidance.
  Stated by Royal College of RadiologistsExisting arrangements considered sufficient
1. Position
  The Trust cannot definitively quantify ascitic tap risks because specific published evidence is absent, a national or international problem.
  Stated by Mid Yorkshire Teaching NHS TrustUnable to act
AI-generated summary

Ms Samantha Jade Shillito · 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

Ms Samantha Jade Shillito was significantly unwell when admitted to hospital and underwent an ascitic tap procedure that perforated an artery, causing intra-abdominal bleeding. She deteriorated over the following weekend without medical review or further investigations and died on 27 February 2022. Concerns included missed opportunities to respond to her deterioration, inadequate information about the risks of the procedure and shortcomings in communication with her family.

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.
PFD Monitor interpretation
Lack of quantified published evidence on ascitic tap risks
Wider context from the report
“(2) The ascitic tap procedure was said to be commonly undertaken and was regarded as low risk. The inquest was, however, unable to establish the magnitude of the risks of bleeding, infection or perforation of surrounding structures by reference to the medical literature or statistical evidence. How then can it be said to be a low-risk procedure if the inherent risks have not been quantified? This was viewed as a national (if not an international) problem, which requires published evidence to inform radiological practice. ”
Source location
Ms Samantha Jade Shillito · Prevention of Future Deaths report
Page 2 · concerns
Open source report
Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Existing national guidance adequately reflects the established risks of ascitic drainage, supported by standard ultrasound guidance.

Verbatim wording from the response
“Our specialist interest groups emphasised that the risks of ascitic tap are well established and widely understood in current radiological practice. The use of ultrasound guidance has become standard and has been shown to further reduce complication rates. We therefore believe that the magnitude and nature of these risks are well defined in the published evidence base and are adequately reflected in existing national guidance.”

Source location
Response from The Royal College of Radiologists
Page 2 · response
Published 8 December 2023
Open published response
Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
The Trust cannot definitively quantify ascitic tap risks because specific published evidence is absent, a national or international problem.

Verbatim wording from the response
“As an organisation that provides healthcare, we rely on various sources of information to enable us to quantify the risks of any procedure. The majority of this information is sourced from guidance issued by specialist societies, royal colleges, or developed through literature evidence base/local audits etc. In the instance where there is an absence of specific quantifiable risks, best practice is to inform patients of potential complications with indicative likelihoods of these occurring. For an ascitic tap it is felt to be very low risk based on the experience and judgement of the health professionals involved. Decisions to proceed with an intervention would also be balanced against the risk of not proceeding with an intervention”

Source location
Response from Mid Yorkshire Teaching NHS Trust
Page 3 · response
Published 8 December 2023
Open published response
16 May2016
Surrey
Concerns raised1
1. Use of 6 f gauge pigtail catheters for pleural effusions without supporting evidence
This report raised 22 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 2
1. Action
  Promote British Thoracic Society guidance specifying larger 10–14 gauge tubes for pleural infection management.
  Stated by Circle Health Group LimitedStated completed
2. Action
  Make Fellows and members aware of the BTS Pleural Disease Guideline 2010 Quick Reference Guide.
  Stated by Royal College of RadiologistsStated planned
AI-generated summary

Mr Critall · 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

Mr Critall, an 80-year-old man, developed a haemothorax after insertion of a chest drain while being treated for pneumonia and died on 6 July 2014 after further deterioration and emergency treatment. The report raised concerns about the necessity and technique of the drain insertion, the failure to confirm its position, inadequate monitoring and resuscitation, and the hospital’s lack of appropriate emergency facilities and protocols. It also recorded that his family were not contacted after he became unwell or died.

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.
PFD Monitor interpretation
Use of 6 f gauge pigtail catheters for pleural effusions without supporting evidence
Wider context from the report
“8. The use of a 6 f gauge pig tail catheter in the management of pleural effusions with or without an empyema was against both national guidelines and expert evidence heard at inquest and was unsupported by either international research or any recent local audits undertaken to justify their use in preference for larger small bore chest drains. ”
Source location
Mr Critall · Prevention of Future Deaths report
Page 3 · concerns
Open source report
Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Promote British Thoracic Society guidance specifying larger 10–14 gauge tubes for pleural infection management.

Verbatim wording from the response
“1. As discussed previously in the response to Concern 6, BTS guidance for the management of patients with pleural infection is promoted which includes reference to the use of a larger bore tube size 10 – 14.”

Source location
2016-0187-Response-by-Mount-Alvernia-Hospital
Page 6 · response
Published 16 May 2016
Open published response
Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Make Fellows and members aware of the BTS Pleural Disease Guideline 2010 Quick Reference Guide.

Verbatim wording from the response
“In the light of your report, we are taking steps later this month to make our Fellows and members aware once again of these important guidelines.”

Source location
2016-0187-Response-by-Royal-College-of-Radiologists
Page 1 · response
Published 16 May 2016
Open published response
4 Mar2014
Avon
Concerns raised1
1. Lack of published evidence supporting assisted self-harming as a treatment approach
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Actions described in response 1
1. Action
  Undertake research into whether harm minimisation strategies are appropriate for use.
  Stated by Avon and Wiltshire Mental Health Partnership NHS TrustStated planned
AI-generated summary

Ms. Kimberley Parsons · 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

Ms. Kimberley Parsons, who had a history of mental health problems and suicidal ideation, was found hanging in her room at Sycamore Ward on 16 March 2014 after repeated self-harm during her admission. She was transferred to intensive care but died from her injuries on 24 March 2014. Concerns included serious patient-safety deficiencies at Hillview Lodge, including incomplete observation records, shortcomings in resuscitation equipment and training, and deficiencies in care planning and pathways for patients with emotionally unstable personality disorder.

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.
PFD Monitor interpretation
Lack of published evidence supporting assisted self-harming as a treatment approach
Wider context from the report
“(1) The suggestion made to Ms. Parsons, a person with a history of self-harming and who remained at high risk of self-harming, that she could be assisted with self-harming was not an approach to patient care and treatment which was supported by any reference to the results of any research published in a peer-reviewed professional journal. Therefore if this is a bona fide approach to treatment in a high risk patient then the Trust should be able to justify that this is a recognised and generally accepted practice by reference to the published literature and/or results of published research. (2) If the Trust cannot provide evidence to support this treatment being a recognised and generally accepted practice then the Trust must establish proper procedures for the introduction and use of novel treatments including the obtaining of any necessary ethical approvals. (3) This discussion with regard to ‘assisted self-harming’ was not discussed by the nurse with the consultant psychiatrist nor was any record made of the discussion. The Trust should undertake a proper review of any training with respect to these matters so as to ensure any discussions with regard to proposed treatment are had with the full knowledge and agreement of the consultant in charge and that those discussions are properly recorded. ”
Source location
Ms. Kimberley Parsons · Prevention of Future Deaths report
Page 2 · concerns
Open source report
Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation
Undertake research into whether harm minimisation strategies are appropriate for use.

Verbatim wording from the response
“The Medical Director has liaised with the national expert in this field. ████████ who will soon be joining the University of Bristol and our trust. We will be looking at the possibility of research into the appropriateness, or not, of employing harm minimisation strategies.”

Source location
2015-0077-Response-by-Avon-Wiltshire-NHS-Trust
Page 1 · response
Published 4 March 2015
Open published response

Data last updated 7 September 2026

What this concern includes

Not included

Reports over time

Concerns raised1

Use of inappropriate research providing false reassurance about suprapubic catheter risks in patients with lower abdominal surgery

Concerns raised1

Lack of quantified published evidence on ascitic tap risks

Respondent positions A position is what a respondent says about the concern when they do not describe a specific action.2

Concerns raised1

Use of 6 f gauge pigtail catheters for pleural effusions without supporting evidence

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.2

Concerns raised1

Lack of published evidence supporting assisted self-harming as a treatment approach

Actions described in response An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised.1

Respondent positions 2

Actions described in response 2

Actions described in response 1