Surgery--ComplicationsNCT03720834
Verbal Probability Expressions in Peri-operative Risk
An observational study of Surgery--Complications and Risk Reduction, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Before having an operation doctors use expressions such as high risk, or low risk to describe the chance of complications occurring. Complications include things such as strokes and heart attacks and even death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Risk Reduction
- How many people
- 347 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2018to 21 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Surgical population
Who may be able to join
- Any patient due to undergo surgery who attends pre-operative assessment clinic
Who cannot join
- Inability to speak/read English; inability to provide own consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospital NHS Foundation Trust
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: What is the Numerical Translation of Verbal Probability Expressions Used by Patients and Doctors in the Context of Communication of Peri-operative Risk?
Before having an operation doctors use expressions such as high risk, or low risk to describe the chance of complications occurring. Complications include things such as strokes and heart attacks and even death. It is thought that using words like this, instead of percentages makes it easier for patients to understand their level of risk. It is also often hard for a doctor to give a patient an exact percentage.
It is important that patients have a good understanding about their level of risk associated with an operation so they can make informed decisions about whether to go ahead with it. This is an important part of taking consent before an operation.
Read more
The aim of this study is to assess whether using expressions such as high risk and low risk to communicate the chance of a complication occurring during an operation is useful.
Different patients may assign different meanings to these expressions. If it is found that patients interpret these expressions differently from how the doctor intended it would suggest that the way doctors communicate risk to patients should be reviewed.
Patients will be asked if they are willing to participate in the study and after giving consent they will complete a questionnaire. The questionnaire will list various expressions used by doctors to describe the chance of a complication occurring during an operation, such as high risk and low risk. Each participant will be asked to give a percentage for each of the expressions. The questionnaire will be completed by patients who are waiting to have an operation at the Royal Hallamshire Hospital.
Read the detailed description
Shared decision-making is central to the consent process prior to surgery and anaesthesia. Verbal probability expressions are commonly used by clinicians to help describe the level of risk. Common examples of verbal probability expressions are shown below with the estimated numerical risk shown in parentheses:
- High risk (1:100)
- Moderate risk (1:100-1:1000)
- Low risk (1:1000-1:10 000)
- Standard risk (varies depending on patient/procedure etc.)
- Very low risk (1:10 000)
- Minimal risk (1:100 000)
- Negligible risk (1:1 000 000)
Verbal probability expressions are commonly used because they are perceived as being easier to understand than, for example, percentage risk, as this is affected by how numerate a patient is. Clinicians often prefer verbal probability expressions as they avoid assigning an exact percentage of risk; this is because risk prediction is an inexact science and from an individual patient perspective, risk of complications is often a dichotomous outcome - their individual experience will be either a 0% or 100% incidence of complications, depending on whether it happens to them or not. Percentage risk only really applies to large populations, not individual patients.
Shared decision-making is central to the consent process prior to surgery and anaesthesia. With pre-operative clinics, risk indices are often described according to Calman's verbal scale illustrated above (high, moderate, low, very low etc.). However, the actual level of harm that is perceived by the patient and clinician may differ, due a variety of factors, not least a lack of understanding of the underlying numerical concepts. In addition, the level of risk assigned to these by clinicians and the level perceived by patients may differ. For example, a clinician may view a 20% probability of a complication after cancer surgery is high-risk, when compared to their own experience of the procedure; the patient who is living with the disease may see this as a low-risk, given their individual perception of the disease.
This study aims to investigate this and to see if verbal probability expressions are still useful for communication of pre-operative risk. If the study finds large inter-individual variability between patients, then this would suggest that the use of verbal probability expressions in discussions should be reviewed. This may include the need for verbal probability expressions to be used in conjunction with a numerical estimate of risk, or for the terms used (high-risk, low-risk) to be revised. The results of this study may have significant implications at national level in terms of the consent process for surgical procedures.
After gaining consent, a questionnaire with various verbal probability expressions will be completed by clinicians and patients. Each participant will be asked to assign a percentage of likelihood (i.e. a numerical translation) of an adverse outcome according to each verbal probability expression. For example, one patient may perceive the phrase 'high-risk" as an incidence risk in excess of 50%, whilst another may perceive the risk to be 20%.
A researcher will be available to answer any questions will occur during the completion of the questionnaire.
The study is observational.
The numerical translation of different verbal probability expressions will be displayed graphically to illustrate variation (if any). For example, if the phrase 'high-risk" is perceived by patients as a percentage risk ranging from 20-70%, whilst anaesthetists and surgeons perceive 'high-risk' as 10-20%, then this particular verbal probability expression would be of limited value.
We will use ANOVA to analyse if there is any difference in the level risk assigned to different verbal probability expressions by patients and anaesthetists (after testing for normality of data distribution). For example, do patients recognise a meaningful difference between low and minimal risk?
Regression analyses will also be undertaken to determine if any patient factors alter the perception of risk. This will include: sex; calculated Surgical Outcome Risk Tool score; cancer vs. non-cancer surgery; ethnicity; and surgical speciality.
- Conditions
- Surgery--Complications, Risk Reduction
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Questionnaire on risk perception | |
| Clinicians | Questionnaire on risk perception |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the perceived peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions in patients awaiting surgery.
Percentage risk assigned to verbal risk descriptors
Measured: Day 0
Secondary outcomes (3)
To determine the implied patient peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions that are used by clinicians in the pre-operative setting.
Percentage risk assigned to verbal risk descriptors
Measured: Day 0
To determine the level of correlation between clinicians and patient perception of risk when verbal probability expressions are used.
Percentage risk assigned to verbal risk descriptors
Measured: Day 0
To investigate the impact of patient sex, surgical speciality, presence of carcinoma, and calculated risk of surgery on patient perception of risk when verbal probability expressions are used.
Logistic regression
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Nov 2018
- Primary completion21 Jul 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720834
- Sponsor's protocol ID
- STH20393
- Status last verified
- Sep 2019
- First submitted
- 17 Oct 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Numerical Translation of Verbal Probability Expressions Used by Patients and Doctors in the Context of Communication of Peri-operative Risk?
- ClinicalTrials.gov ID
- NCT03720834
- Acronym / sponsor ID
- STH20393
- Conditions
- Surgery--Complications, Risk Reduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Before having an operation doctors use expressions such as high risk, or low risk to describe the chance of complications occurring. Complications include things such as strokes and heart attacks and even death. It is thought that using words like this, instead of percentages makes it easier for patients to understand their level of risk. It is also often hard for a doctor to give a patient an exact percentage.
It is important that patients have a good understanding about their level of risk associated with an operation so they can make informed decisions about whether to go ahead with it. This is an important part of taking consent before an operation.
The aim of this study is to assess whether using expressions such as high risk and low risk to communicate the chance of a complication occurring during an operation is useful.
Different patients may assign different meanings to these expressions. If it is found that patients interpret these expressions differently from how the doctor intended it would suggest that the way doctors communicate risk to patients should be reviewed.
Patients will be asked if they are willing to participate in the study and after giving consent they will complete a questionnaire. The questionnaire will list various expressions used by doctors to describe the chance of a complication occurring during an operation, such as high risk and low risk. Each participant will be asked to give a percentage for each of the expressions. The questionnaire will be completed by patients who are waiting to have an operation at the Royal Hallamshire Hospital.
Detailed description
Shared decision-making is central to the consent process prior to surgery and anaesthesia. Verbal probability expressions are commonly used by clinicians to help describe the level of risk. Common examples of verbal probability expressions are shown below with the estimated numerical risk shown in parentheses:
- High risk (1:100)
- Moderate risk (1:100-1:1000)
- Low risk (1:1000-1:10 000)
- Standard risk (varies depending on patient/procedure etc.)
- Very low risk (1:10 000)
- Minimal risk (1:100 000)
- Negligible risk (1:1 000 000)
Verbal probability expressions are commonly used because they are perceived as being easier to understand than, for example, percentage risk, as this is affected by how numerate a patient is. Clinicians often prefer verbal probability expressions as they avoid assigning an exact percentage of risk; this is because risk prediction is an inexact science and from an individual patient perspective, risk of complications is often a dichotomous outcome - their individual experience will be either a 0% or 100% incidence of complications, depending on whether it happens to them or not. Percentage risk only really applies to large populations, not individual patients.
Shared decision-making is central to the consent process prior to surgery and anaesthesia. With pre-operative clinics, risk indices are often described according to Calman's verbal scale illustrated above (high, moderate, low, very low etc.). However, the actual level of harm that is perceived by the patient and clinician may differ, due a variety of factors, not least a lack of understanding of the underlying numerical concepts. In addition, the level of risk assigned to these by clinicians and the level perceived by patients may differ. For example, a clinician may view a 20% probability of a complication after cancer surgery is high-risk, when compared to their own experience of the procedure; the patient who is living with the disease may see this as a low-risk, given their individual perception of the disease.
This study aims to investigate this and to see if verbal probability expressions are still useful for communication of pre-operative risk. If the study finds large inter-individual variability between patients, then this would suggest that the use of verbal probability expressions in discussions should be reviewed. This may include the need for verbal probability expressions to be used in conjunction with a numerical estimate of risk, or for the terms used (high-risk, low-risk) to be revised. The results of this study may have significant implications at national level in terms of the consent process for surgical procedures.
After gaining consent, a questionnaire with various verbal probability expressions will be completed by clinicians and patients. Each participant will be asked to assign a percentage of likelihood (i.e. a numerical translation) of an adverse outcome according to each verbal probability expression. For example, one patient may perceive the phrase 'high-risk" as an incidence risk in excess of 50%, whilst another may perceive the risk to be 20%.
A researcher will be available to answer any questions will occur during the completion of the questionnaire.
The study is observational.
The numerical translation of different verbal probability expressions will be displayed graphically to illustrate variation (if any). For example, if the phrase 'high-risk" is perceived by patients as a percentage risk ranging from 20-70%, whilst anaesthetists and surgeons perceive 'high-risk' as 10-20%, then this particular verbal probability expression would be of limited value.
We will use ANOVA to analyse if there is any difference in the level risk assigned to different verbal probability expressions by patients and anaesthetists (after testing for normality of data distribution). For example, do patients recognise a meaningful difference between low and minimal risk?
Regression analyses will also be undertaken to determine if any patient factors alter the perception of risk. This will include: sex; calculated Surgical Outcome Risk Tool score; cancer vs. non-cancer surgery; ethnicity; and surgical speciality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Questionnaire on risk perception |
| Clinicians | – | –Questionnaire on risk perception |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Surgical population
Key inclusion criteria (1 listed)
- Any patient due to undergo surgery who attends pre-operative assessment clinic
Key exclusion criteria (1 listed)
- Inability to speak/read English; inability to provide own consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the perceived peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions in patients awaiting surgery.
Time frame: Day 0
Percentage risk assigned to verbal risk descriptors
3 secondary outcomes
To determine the implied patient peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions that are used by clinicians in the pre-operative setting.
Time frame: Day 0
To determine the level of correlation between clinicians and patient perception of risk when verbal probability expressions are used.
Time frame: Day 0
To investigate the impact of patient sex, surgical speciality, presence of carcinoma, and calculated risk of surgery on patient perception of risk when verbal probability expressions are used.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Risk Reduction, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the perceived peri-operative risk (as a percentage incidence) associated with a variety of verbal probability expressions in patients awaiting surgery. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2019; AzTrials last refreshed its copy on 1 Nov 2026.