Management - Legal Issues

Question 1 of 41
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As the SpR in general surgery you wish to determine whether your breast cancer
unit is complying with the British Association of Surgical Oncology guidelines for
management of high grade ductal carcinoma in situ. What is the best course of
action?
Undertake a clinical audit
Undertake a clinical review
Undertake a service evaluation
Discuss the case with the ethics committee
Discuss selected cases at joint histopathology meetings
Since this comparison with practice against an agreed standard, the correct
course of action is to undertake an audit.
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Audit and Research
Clinical audit
Quality improvement process that seeks to improve patient care and outcomes
through systematic review of care against explicit criteria and the implementation
of change. Aspects of the structure, processes, and outcomes of care are selected
and systematically evaluated against explicit criteria. Where indicated, changes are
implemented at an individual, team, or service level and further monitoring is used
to confirm improvement in healthcare delivery. (NICE).
Research
Aims to derive new knowledge which is potentially generalisable or transferable.
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A 64%
B 11.6%
C 10.8%
D 7.2%
E 6.4%
64% of users answered this question correctly
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Question 2 of 41
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A surgical department wishes to determine whether it is using types of prosthetic

mesh material for incisional hernia surgery in the most effective manner. Recently
there have been cases of non mesh usage and loss of material as a result of the
implants being 'out of date'. What is the most appropriate method to investigate
this?
System based audit
Standards audit
Peer review
Financial audit
Operational audit
This is primarily an issue of stock control. However, the system by which the
materials are used within the theatre will need evaluation. Because it is the usage
and stock that are a problem, rather than the sourcing the systems based audit will
be more effective than an operational audit.
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Audit categories
Audits may be used in a variety of clinical settings. These range from standards
based audits, which will be familiar to most clinicians, through to systems based
audits which focus more on the processes within an organisation.
Types of audit
Financial audit A historically oriented, independent evaluation performed for
the purpose of attesting to the fairness, accuracy, and
reliability of financial data
Operational A future-oriented, systematic, and independent evaluation of

audit organizational activities. Financial data may be used, but the
primary sources of evidence are the operational policies and
achievements related to organizational objectives. Internal
controls and efficiencies may be evaluated during this type of
review.
Departmental A current period analysis of administrative functions, to

review evaluate the adequacy of controls, safeguarding of assets,
efficient use of resources, compliance with related laws,
regulations and institutional policy and integrity of financial
information.
Standards Comparison of care or passage of care against set and

based audit widely agreed standards or outcomes.
Systems Evaluation of processes occurring within an institution.

based audit
Systems based audits are an integral part of the process of clinical governance.
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Question 3 of 41
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In medical statistics, which of the following does a p value of 0.04 represent?
Risk of type 1 Error
Risk of type 2 Error
Size of power of the study
Sample size
Number of degrees of freedom
P values are related to the significance levels of a statistical test and therefore are
in effect measuring the risk of a type 1 error.
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Statistical error
Type 1 Error Test rejects true null hypothesis

Rate of type 1 error is the given the value of α
It usually equals the significance level of a test
Type 2 Error Test fails to reject a false null hypothesis

Rate of type 2 errors is given the value of β
It is related to the power of the test
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A 38.1%
B 17.2%
C 24.4%
D 10.1%
E 10.1%
38.1% of users answered this question correctly
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Question 4 of 41
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You have been asked to investigate the potential benefit of setting up a service to
help patients with stomas in the local area. What is the most important factor
when determining how many resources will be required?
Incidence
Bayesian factor
Prevalence
Denominator data
P value
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Incidence and prevalence
These two terms are used to describe the frequency of a condition in a population.
The incidence is the number of new cases per population in a given time period.
For example, if condition X has caused 40 new cases over the past 12 months per
1,000 of the population the annual incidence is 0.04 or 4%.
The prevalence is the total number of cases per population at a particular point in
time.
For example, imagine a questionnaire is sent to 2,500 adults asking them how
much they weigh. If from this sample population, 500 of the adults were obese
then the prevalence of obesity would be 0.2 or 20%.
Relationship
prevalence = incidence * duration of condition
in chronic diseases the prevalence is much greater than the incidence
in acute diseases the prevalence and incidence are similar. For conditions
such as the common cold the incidence may be greater than the prevalence
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Question 5 of 41
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What is the reciprocal of absolute risk reduction?
Odds ratio
Number needed to treat
False positive
False negative
None of the above
In epidemiology, the absolute risk reduction, or risk difference is the decrease in

risk of a given activity or treatment in relation to a control activity or treatment. It is
the inverse of the number needed to treat.
Please rate this question: NNT=1/ARR
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Absolute risk reduction
The absolute risk reduction is the decrease in risk of a given activity or treatment in
relation to a control activity or treatment. It is the inverse of the number needed to
treat.
The absolute risk reduction is usually calculated for two different treatments. For
example, consider surgical resection (X) versus watchful waiting (Y) for prostate
cancer. A defined end point, such as 5 year survival is required. If the probabilities
pX and pY of this end point are known then the absolute risk reduction is
calculated (pX-pY).
The inverse of absolute risk reduction is the Number Needed to Treat . This is
useful in determining the cost Vs benefit of many treatments.
Definition: how many patients would need to receive a treatment to prevent one
event. It is the absolute difference between two treatments.
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Question 6 of 41
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A surgeon has conducted a piece of research and is trying to make his non
parametric data appear interesting for publication. To do this he is conducting
multiple analyses of sub group data using multiple tests. Which of the tests listed
below should be considered?
LSD post hoc test
Bonferroni correction
Unpaired T test
Paired T test
Chi squared test
This is a process referred to as data dredging and can lead to erroneous results.
Post hoc testing in general can be a problem in research and to try and minimise
the potential for error some advocate the use of the Bonferroni method. This
adjusts the test to take account of the number of tests that have been performed
on the data.
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Statistics
Statistics is a topic that generally strikes fear and dread into most surgeons
hearts. The MRCS is not an examination designed to test mathematical skill but
the examiners do expect you to have working knowledge of commonly used tests
so that you can appraise the literature properly.
Data types
Before selecting a method of statistical analysis it is imperative that the type of
data to be analysed is correctly categorised. Commonly used terms include
nominal, ordinal, interval and continuous.
Term Interpretation
Nominal Data can be allocated a numerical code that is arbitrary. For

example allocating people as alive or dead using codes of 0 or 1
Ordinal data Data using numbers that can be used on a scale. Severity of pain
is often measured in this way
Interval Data is measured numerically. However, the zero point is

scale arbitrary
Continuous Data is measured numerically where the numerical value is a real

number and may be any value. Examples include height and
weight
Analysing data
Having ascribed the data it is then possible to begin the process of analysis.
Nominal data is often tabulated into categories because of the nature of the
underlying data sets. Continuous data may be displayed graphically often as
individual data points. When the sample size is large enough, continuous data can
be analysed to determine the distribution of the data points. Often, but not always
these will be in the form of a gaussian distribution. Determining whether data is
normally distributed or not is key to making sense of the subsequent statistical
tests. Parametric tests are used to test normally distributed data, the T Test is one
of the best examples. Data which is not normally distributed cannot be analysed in
this way and a non parametric test must be used. Examples of such tests include
Chi Squared and Mann Whitney U tests. Chi squared tests often appear in the
medical literature. There are some assumptions that are made in relation to Chi
squared tests; these include the need to use 2 degrees of freedom (usually) and
the minimum sample size. Where the sample size is small then a different test is
appropriate and the Fishers exact test is often used.
In situations where data is normally distributed and paired samples are taken from
the same individuals (such as following an intervention) then the paired T Test
may be used.
Multiple testing and post hoc analysis

In the ideal world statistical analysis is conducted on data that is collected
prospectively according to pre set power calculations and defined end points.
Occasionally, data does not produce an expected outcome or a certain type of
patient appears to have a different result. Subsequent analysis of such groups is
termed a post hoc analysis. This can be perfectly legitimate, alternatively it can
represent the last ditch attempt of a researcher to try and find any aspect of the
data that is worthwhile. This can lead to errors and false rejection of a null
hypothesis. A statistically significant result is more likely to occur if the same
dataset is subjected to multiple analyses. To counteract this problem some
researchers will apply a Bonferroni correction, this adjusts the analysis to allow for
multiple testing.
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Question 7 of 41
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A consultant surgeon is undertaking increasingly complex neonatal surgery.

However, this is in breach of guidance following a series of adverse outcomes.
Previously it had been stated that these should be performed with close
supervision. Two further babies die and the surgeon still refuses to undertake
these procedures under supervision. What is the correct course of action?
Review the cases at the next mortality and morbidity meeting
Discuss the situation with the coroner
Arrange for it to be discussed at the consultants next appraisal
Discuss the matter with the General Medical Council
Discuss the matter with the British Medical Association
It is likely that the practice restrictions were imposed by the GMC and given that
there is an ongoing risk to patients and the surgeon is in breach of those practice
restrictions, it would be appropriate to raise this with the GMC.
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Audit and Research
Clinical audit
Research
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A 14.1%
B 9.6%
C 11%
D 56.2%
E 9.1%
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Question 8 of 41
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A 6 year old is hit by a car and is brought to the emergency department. He is

haemodynamically unstable with bilateral femoral shaft fractures and concerns
that he may have a ruptured spleen. The parents have refused blood transfusions
on religious grounds. What is the correct course of action?
Proceed with treatment
Do not proceed with treatment
Apply to court
Apply for an IMCA
Contact the PALS service
In the UK, the GMC and common law advises that emergency life saving treatment
can be given to a child irrespective of the parents views. There is clearly
insufficient time here to apply to a court.
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Consent
There are 3 types of consent:
1. Informed
2. Expressed
3. Implied
Consent forms used in UK NHS
Consent For competent adults who are able to consent for themselves
Form 1 where consciousness may be impaired (e.g. GA)
Consent For an adult consenting on behalf of a child where
Form 2 consciousness is impaired
Consent For an adult or child where consciousness is not impaired

Form 3
Consent For adults who lack capacity to provide informed consent

Form 4
Capacity
Key points include:
1. Understand and retain information
2. Patient believes the information to be true
3. Patient is able to weigh the information to make a decision
All patients must be assumed to have capacity
Consent in minors
Young children and older children who are not Gillick competent cannot consent
for themselves. In British law the patients biological mother can always provide
consent. The child's father can consent if the parents are married (and the father is
the biological father), or if the father is named on the birth certificate (irrespective
of marital status). If parents are not married and the father is not named on the
birth certificate then the father cannot consent.
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A 54.2%
B 9.5%
C 10.3%
D 13.8%
E 12.1%
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Question 9 of 41
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A group of surgeons wish to determine whether patients are receiving adequate

deep vein thrombosis prophylaxis following surgery. What is the most appropriate
process to determine this?
Departmental review
Peer review
Financial audit
Systems based audit
Standards based audit
This type of audit is widely undertaken in most trusts in the UK.
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Audit categories
Types of audit


review.

information.


based audit
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B 10.1%
C 7.2%
D 17.4%
E 50.6%

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Question 10 of 41
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Which of the following statements is false in relation to consent?
All adults by law are assumed to be competent
The Bolam test defines if a patient has capacity or not
Consent 2 is the form signed by parents on behalf of their children
Implied consent is a form of consent
Consent 4 is the form signed when a patient is unable to consent for a

treatment or investigation
The Bolam test defines if a decision made by a doctor is in agreement with the
professional standard of medical practise.
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Consent
1. Informed
2. Expressed
3. Implied

Form 3

Form 4
Capacity
Key points include:
Consent in minors
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A 21.9%
B 46.6%
C 9.5%
D 11.3%
E 10.7%

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Question 10 of 41
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Which of the following statements is false in relation to consent?
All adults by law are assumed to be competent
The Bolam test defines if a patient has capacity or not
Consent 2 is the form signed by parents on behalf of their children
Implied consent is a form of consent
Consent 4 is the form signed when a patient is unable to consent for a

treatment or investigation
The Bolam test defines if a decision made by a doctor is in agreement with the
professional standard of medical practise.
Next question 
Consent
1. Informed
2. Expressed
3. Implied

Form 3

Form 4
Capacity
Key points include:
Consent in minors
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A 21.9%
B 46.6%
C 9.5%
D 11.3%
E 10.7%

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Question 11 of 41
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Which of the following statements relating to qualitative data is false?
The data has no true numerical scale
It may comprise multiple data groups
May be reported using odds ratios
May be reported using frequency histograms
It is best analysed statistically using a students T test when multiple

factors are present
The students T test should be performed if two sets of data have a normal
distribution, the T test cannot be used to analyse multiple data sets.
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Qualitative and quantitative data

Qualitative (categorical) data refers to different descriptions of a characteristic,
although it may be possible to allocate a number it has no scale.
Quantitative data is associated with numerical values on a numerical scale.
Since quantitative data is based on a numerical scale it can be organised to create

a distribution curve. The central tendency may be estimated using the mode,
median and mean. The standard deviation gives an estimation of the spread of
data.
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Question 12 of 41
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Which of the following statements relating to audit and governance is untrue?
An audit standard is a threshold of compliance with an audit criterion
Sample size calculations are an important part of audit planning
Clinical audit is part of clinical governance
Audits should be performed regularly when a novel surgical technique is

introduced and where there is little knowledge of anticipated
complications or outcomes
An audit criterion is a measurable outcome of care, aspect of practice or

capacity
6 pillars of clinical governance:

Clinical effectiveness
Research and development
Openness
Risk management
Education and training
Clinical audit
Audits should compare performance against known standards. Where a novel

technique is being introduced standards are unlikely to exist, sample sizes cannot
therefore be accurately calculated. This is an example of research, which is not an
audit.
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Audit and Research

Clinical audit
Research
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Question 13 of 41
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A new hernia mesh designed to prevent the risk of infection undergoes clinical
trials. One hundred patients are given the new mesh. During a three month period
10 of the patients have an episode of infection. In the control group there are 300
patients who are given a placebo. In this group 50 people have an infection during
the same time period. What is the relative risk of having an infection when the new
mesh is used?
0.8
0.2
1.66
0.6
0.06
Experimental event rate, EER = 10 / 100 = 0.10
Control event rate, CER = 50 / 300 = 0.166
Therefore the relative risk = EER / CER = 0.1 / 0.166 = 0.6
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Relative risk
Relative risk (RR) is the ratio of risk in the experimental group (experimental event
rate, EER) to risk in the control group (control event rate, CER)
To recap
EER = rate at which events occur in the experimental group
CER = rate at which events occur in the control group
For example, if we look at a trial comparing the use of paracetamol for back pain
compared to placebo we may get the following results
Total number of patients Experienced significant pain relief
Paracetamol 100 60
Placebo 80 20
Experimental event rate, EER = 60 / 100 = 0.6
Control event rate, CER = 20 / 80 = 0.25
Therefore the relative risk = EER / CER = 0.6 / 0.25 = 2.4
If the risk ratio is > 1 then the rate of an event (in this case experiencing significant
pain relief) is increased compared to controls. It is therefore appropriate to
calculate the relative risk increase if necessary (see below).
If the risk ratio is < 1 then the rate of an event is decreased compared to controls.
The relative risk reduction should therefore be calculated (see below).
Relative risk reduction (RRR) or relative risk increase (RRI) is calculated by

dividing the absolute risk change by the control event rate
Using the above data, RRI = (EER - CER) / CER = (0.6 - 0.25) / 0.25 = 1.4 = 140%
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Question 14 of 41
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Which of the following is not usually required to make a power calculation?
The specificity of the intervention being tested
The desired significance level
The size of the effect being measured
The desired power value
Sample size used to detect the effect
The specificity of a test is related to type 1 errors.
The components that are nearly always needed for power calculations are :
Size of effect
Significance level
Sample size used to detect the effect
Desired power value
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Power calculations and statistical error
Statistical error
Type 1 A test rejects a true null hypothesis. Analogus to false positive. It

Error usually equates to the significance level assigned to a test.
Type 2 A test fails to reject a false null hypothesis. It is related to the power
Error of a test.
Statistical power
The power of a test is the probability that the test will reject the null hypothesis
when it is false (thereby avoiding a type 2 error). Increasing the power of a test will
reduce the probability of a type 2 error. Usually a value of 0.8 is selected.
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Question 15 of 41
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In Intention to treat analysis, which statement is untrue?
It is based on the initial treatment intended.
Excludes those who cross over to alternative treatment arms of a trial.
Is different from a per protocol analysis.
Will affect the statistical power calculation to compare outcomes of

treatment.
Helps to minimise observer bias.
An intention to treat analysis considers data according to the treatment to

which the patient was randomised, rather than the treatment which was
recieved.
It includes those who cross over which is how it helps provide additional
information relating to those groups.
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Audit and Research
Clinical audit
Research
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Question 16 of 41
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You are performing a study of weight in patients attending pre operative

assessment clinic for elective knee replacement. Assuming that the results are
normally distributed, what percentage of values lie within two standard deviations
of the mean weight?
95.4%
5.3%
98.3%
10%
97.5%
In statistics, the 68-95-99.7 rule or three-sigma rule, or empirical rule states

that for a normal distribution, nearly all values lie within 3 standard deviations
of the mean.
About 68.27% of the values lie within 1 standard deviation of the mean.
Similarly, about 95.45% of the values lie within 2 standard deviations of the
mean. Nearly all (99.73%) of the values lie within 3 standard deviations of the
mean
95.4% of values lie within 2 SD of the mean.
Next question 
Normal distribution
The normal distribution is also known as the Gaussian distribution or 'bell-shaped'

distribution. It describes the spread of many biological and clinical measurements
Properties of the Normal distribution
symmetrical i.e. Mean = mode = median
68.3% of values lie within 1 SD of the mean

this is often reversed, so that within 1.96 SD of the mean lie 95% of the
sample values
the range of the mean - (1.96 *SD) to the mean + (1.96 * SD) is called the
95% confidence interval, i.e. If a repeat sample of 100 observations are
taken from the same group 95 of them would be expected to lie in that range
Standard deviation
the standard deviation (SD) represents the average difference each
observation in a sample lies from the sample mean
SD = square root (variance)
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Question 17 of 41
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Which one of the following is equivalent to the pre-test probability?
Post test odds / (1 + post-test odds)
Pre-test odds x likelihood ratio
The prevalence of a condition
The incidence of a condition
Post-test odds / likelihood ratio
The prevalence is the proportion of a population that have the condition at a point
in time whilst the incidence is the rate at which new cases occur in a population
during a specified time period.
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Pre- and post- test odds and probability
Pre-test probability
The proportion of people with the target disorder in the population at risk at a
specific time (point prevalence) or time interval (period prevalence)
For example, the prevalence of rheumatoid arthritis in the UK is 1%
Post-test probability
The proportion of patients with that particular test result who have the target
disorder
Post-test probability = post test odds / (1 + post-test odds)
Pre-test odds
The odds that the patient has the target disorder before the test is carried out
Pre-test odds = pre-test probability / (1 - pre-test probability)

Post-test odds
The odds that the patient has the target disorder after the test is carried out
Post-test odds = pre-test odds x likelihood ratio
where the likelihood ratio for a positive test result = sensitivity / (1 - specificity)
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Question 18 of 41
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Surgeons are becoming increasing concerned about the adverse results of Mrs X
performing a new an innovative operative procedure not widely practised
elsewhere. What is the most appropriate investigation?
Peer review
Standards audit
System based audit
Operational audit
Financial audit
In the situation where a surgeon performs an unfamiliar procedure, a peer review is

often the best way to evaluate the problem. This does not have to be externally
based, but often is.
Next question 
Audit categories
Types of audit


review.

information.


based audit
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Question 19 of 41
 
A group of surgeons conduct a meta analysis of randomised controlled trials

comparing the use of analgesic regimes following laparoscopic cholecystectomy.
What level of evidence is provided by such an analysis?
II
III
IV
Next question 
Study design: evidence and recommendations
Levels of evidence
I - evidence from meta-analysis of randomised controlled trials
II - evidence from at least one well designed controlled trial which is not
randomised
III - evidence from correlation and comparative studies or use of historical
controls
IV - evidence from case series
V - Expert opinion or founded on basic principles
Knowledge of the sub groups of the levels of evidence are not routinely tested in
MRCS Part A.
Grading of recommendation
Grade A - based on evidence from at least one randomised controlled trial
(i.e. Ia or Ib)
Grade B - based on evidence from non-randomised controlled trials (i.e. IIa,
IIb or III)
Grade C - based on evidence from a panel of experts (i.e. IV)
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Question stats
A 11.2%
B 59%
C 12.1%
D 8.6%
E 9.1%
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Question 20 of 41
 
A cohort study is being designed to look at the relationship between smoking and
breast cancer. What is the usual outcome measure in a cohort study?
Odds ratio
Experimental event rate
Relative risk
Absolute risk increase
Numbers needed to harm
Cohort studies - relative risk
Next question 
Study design
The following table highlights the main features of the main types of study:
Randomised Participants randomly allocated to intervention or control

controlled trial group (e.g. standard treatment or placebo)
Practical or ethical problems may limit use

Cohort study Observational and prospective. Two (or more) are selected
according to their exposure to a particular agent (e.g.
medicine, toxin) and followed up to see how many develop a

disease or other outcome.
The usual outcome measure is the relative risk.
Examples include Framingham Heart Study
Case-control Observational and retrospective. Patients with a particular

study condition (cases) are identified and matched with controls.
Data is then collected on past exposure to a possible causal
agent for the condition.
The usual outcome measure is the odds ratio.
Inexpensive, produce quick results

Useful for studying rare conditions
Prone to confounding
Cross-sectional Provide a 'snapshot', sometimes called prevalence studies

survey
Provide weak evidence of cause and effect
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Question stats
A 23%
B 7.4%
C 50.3%
D 11.6%
E 7.7%

Question 21 of 41
 
5 surgeons in a colorectal unit wish to determine whether there is a significant

difference in their individual leak rates for anterior resection of the rectum. Which
of the following investigations is most appropriate?
Paired T Test
Unpaired T test
Chi squared test
Fishers exact test
Kruskall Wallis test
In this scenario the data is derived from 5 groups of surgeons. If the data were
normally distributed then an ANOVA could be considered. Since these
assumptions cannot be met, or satisfied by transforming the data then the
Kruskall-Wallis test provides a non parametric alternative. This is essentially an
extension of the Wilcoxon Rank sum test and detects differences in median values
between each group. To compare more accurately differences between two
individual surgeons a Mann Whitney U test may be a more acceptable alternative.
Next question 


data.
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Question stats
A 16.9%
B 13.9%
C 19%
D 26.1%
E 24%
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Question 22 of 41
 
Which of the following most closely describes the risk of a type I statistical error?
Power calculation
P value
Odds ratio
Relative risk
None of the above
Type 1 errors occur when a test rejects a true null hypothesis and is therefore
related to the significance level of the test result. To explain consider the following
arbitrary example.
We hypothesise that bowel preparation vs no bowel preparation has no effect on

anastomotic leak rates following left hemicolectomy. If we compare the rates of
anastomotic leak and perform a Chi Squared test and obtained a P value of 0.95
we should conclude that we unable to reject the null hypothesis. Should we choose
to do so then we are at risk of committing a type 1 error. In reality the knowledge
that a type 1 error was committed is usually some time after the event. When other
studies have been performed that have shown an effect.
Power calculations are related to type 2 errors.
Next question 
Power calculations and statistical error
Statistical error
Type 1 A test rejects a true null hypothesis. Analogus to false positive. It

Error usually equates to the significance level assigned to a test.
Type 2 A test fails to reject a false null hypothesis. It is related to the power
Error of a test.
Statistical power
The power of a test is the probability that the test will reject the null hypothesis
when it is false (thereby avoiding a type 2 error). Increasing the power of a test will
reduce the probability of a type 2 error. Usually a value of 0.8 is selected.
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Question stats
A 11%
B 53.4%
C 12.4%
D 13.9%
E 9.3%
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Question 23 of 41
 
Which of the following statements relating to randomised controlled trials is false?
Consist of a control group recruited during the same time interval as the
treatment group.
Are not applicable to retrospectively analysed data even if captured on a

prospectively created database.
They require concealment of treatment throughout the duration of the

study.
They require concealment of treatment until after randomisation.
They are less susceptible to researcher bias than non-randomised

controlled trials.
An RCT does not have to include concealment although many medical trials may
do so. Indeed in the case of surgical research it may not be practicable or possible
to include concealment in the protocol. This does not mean that the trial is not an
RCT, simply that it is not blinded.
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Audit and Research
Clinical audit
Research
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Question stats
A 8.6%
B 17.1%
C 33.3%
D 30.5%
E 10.6%
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Question 24 of 41
 
A new blood test to screen patients for colorectal cancer is trialled on 500
patients. The test was positive in 40 of the 50 patients shown to have colorectal
cancer by colonscopy. It was also positive in 20 patients who were shown not to
have colorectal cancer. What is the positive predictive value of the test?
0.8
0.66
0.33
0.1
Cannot be calculated
A contingency table can be constructed from the above data, as shown below:
Colorectal cancer No colorectal cancer
Test positive 40 TP 20 FP
Test negative 10 FN 430 TN
Positive predictive value = TP / (TP + FP) = 40 / (40 + 20) = 0.66
Next question 
Screening test statistics
It would be unusual for a medical exam not to feature a question based around
screening test statistics. The available data should be used to construct a
contingency table as below:
TP = true positive; FP = false positive; TN = true negative; FN = false negative

Disease present Disease absent
Test positive TP FP
Test negative FN TN
The table below lists the main statistical terms used in relation to screening tests:
Sensitivity TP / (TP + FN ) Proportion of patients with the

condition who have a positive test
result
Specificity TN / (TN + FP) Proportion of patients without the

condition who have a negative test
result
Positive predictive TP / (TP + FP) The chance that the patient has the
value condition if the diagnostic test is
positive
Negative predictive TN / (TN + FN) The chance that the patient does not
value have the condition if the diagnostic
test is negative
Likelihood ratio for a sensitivity / (1 - How much the odds of the disease
positive test result specificity) increase when a test is positive
Likelihood ratio for a (1 - sensitivity) / How much the odds of the disease
negative test result specificity decrease when a test is negative
Positive and negative predictive values are prevalence dependent. Likelihood ratios
are not prevalence dependent
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Question stats
A 22.5%
B 45.4%
C 12.4%
D 9.1%
E 10.5%
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Question 25 of 41
 
In a randomized study of chemotherapy drugs for bowel cancer, a group receiving

treatment A had a recurrence rate of 12.5% and a group receiving treatment B had
a recurrence rate of 15%. Both groups are matched for size and length of follow
up. What is the number needed to treat to prevent a recurrence?
2.5
25
40
There is an absolute risk reduction of 15-12.5%= 2.5% for treatment A

Therefore the NNT = 1/0.025 = 40
Next question 
Absolute risk reduction
The absolute risk reduction is the decrease in risk of a given activity or treatment in
relation to a control activity or treatment. It is the inverse of the number needed to
treat.
The absolute risk reduction is usually calculated for two different treatments. For
example, consider surgical resection (X) versus watchful waiting (Y) for prostate
cancer. A defined end point, such as 5 year survival is required. If the probabilities
pX and pY of this end point are known then the absolute risk reduction is
calculated (pX-pY).
The inverse of absolute risk reduction is the Number Needed to Treat . This is
useful in determining the cost Vs benefit of many treatments.

Definition: how many patients would need to receive a treatment to prevent one
event. It is the absolute difference between two treatments.
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Question stats
A 17.8%
B 21.9%
C 12.5%
D 38.4%
E 9.5%
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Question 26 of 41
 
Considering cluster randomised trials, which of the following statements is false?
They consider interventions targeted at groups
They require increased recruitment to achieve the same level of statistical

power as individual trials
If results are analysed on an individual basis a lower P value may be

obtained
They are less prone to unit of analyses errors than trials involving
individual observations
The statistical analyses for these trials is more complex than that required
for trials based on individuals
Cluster randomised trials are more prone to unit of analyses errors than individual
based trials. Clustering needs to be considered in trial design and data analysis.
One of the commonest errors is where a study is a cluster study but researchers
have failed to recognise this fact. This will then result in the incorrect analysis
being pursued. A lower P value will then result and a false positive error will occur.
Next question 
Cluster randomised controlled trials
Groups are randomised rather than individuals

Avoids cross contamination amongst participants
Participants in any one cluster are more likely to respond in a similar fashion
Higher risk of unit of analysis error as these studies should be analysed as
clusters rather than on an individual basis. This leads to a higher false
positive rate.
It is possible to adjust for clustering in statistical analyses
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Question stats
A 10.6%
B 18.2%
C 19.1%
D 36.5%
E 15.6%
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Question 27 of 41
 
Which of the following has the greatest impact on the positive predictive value of a
test?
Prevalence
Subjects who are true negatives
Specificity
Relative risk
None of the above
The positive predictive value (PPV) is the probability that an individual with a
positive screening result has the disease. The sensitivity is the probability that an
individual with the disease is screened positive and the specificity is the probability
that an individual without the disease is screened negative.
Its value depends upon the prevalence of the condition being tested for and the
sensitivity of the test used.
It may be calculated by dividing the number of true positives by the number of true
positives and the number of false positives.
Next question 
Positive predictive values

Screening tests
Sensitivity: proportion of true positives identified by a test
Specificity: proportion of true negatives correctly identified by a test
Positive predictive value: proportion of those who have a positive test who
actually have the disease
Negative predictive value: proportion of those who test negative who do not
have the disease
Predictive values are dependent on the prevalence
Likelihood ratio for a positive test result = sensitivity/(1-specificity)

Likelihood ratio for a negative test result = (1-sensitivity)/specificity
Likelihood ratios are not prevalence dependent
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Question stats
A 40.1%
B 13.6%
C 25.6%
D 11.5%
E 9.2%
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Question 28 of 41
 
As part of a research project you are trying to ascertain whether the use of
dummies in infants is linked to sudden infant death syndrome. What is the most
appropriate form of study design?
Randomised controlled trial
Cross-over trial
Cross-sectional survey
Case-control study
Cohort study
As sudden infant death syndrome is relatively rare a case-control design is more

appropriate than a cohort study.
Next question 
Study design
The following table highlights the main features of the main types of study:
Randomised Participants randomly allocated to intervention or control

controlled trial group (e.g. standard treatment or placebo)
Practical or ethical problems may limit use

Cohort study Observational and prospective. Two (or more) are selected
according to their exposure to a particular agent (e.g.
medicine, toxin) and followed up to see how many develop a

disease or other outcome.
The usual outcome measure is the relative risk.
Examples include Framingham Heart Study
Case-control Observational and retrospective. Patients with a particular

study condition (cases) are identified and matched with controls.
Data is then collected on past exposure to a possible causal
agent for the condition.
The usual outcome measure is the odds ratio.
Inexpensive, produce quick results

Useful for studying rare conditions
Prone to confounding
Cross-sectional Provide a 'snapshot', sometimes called prevalence studies

survey
Provide weak evidence of cause and effect
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Question stats
A 16.9%
B 7.1%
C 14.4%
D 36.2%
E 25.4%

Question 29 of 41
 
A patient involved in a national research trial of surgery versus conservative

management for ruptured abdominal aortic aneurysms dies during surgery
because the surgeon decided to deviate from the study protocol and implant a
different type of graft material. What is the correct course of action?
Refer the surgeon to the GMC
Report the case to the ethics committee that gave a favorable opinion for
the study
Report it to the responsible officer for the hospital
Report it to the Caldicott guardian for the hospital
Report it to the media
Where a research participant experiences an adverse outcome, the correct course

of action is to refer to the ethics committee that approved the study. Minor adverse
effects are usually reviewed by the data monitoring committee and reported
annually. However, a serious event is reported immediately. It would not be
appropriate to refer to the GMC though, it may be that the surgeon deviated from
the protocol for good reason.
Next question 
Audit and Research
Clinical audit
Research
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Question stats
A 25.8%
B 41.3%
C 18.6%
D 8.5%
E 5.8%
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Question 30 of 41
 
Which one of the following statements best describes a type II statistical error?
The p value fails to reach statistical significance
The alternative hypothesis is rejected when it is false
The null hypothesis is rejected when it is true
The null hypothesis is accepted when it is false
None of the above
Next question 
Significance tests
A null hypothesis (H0) states that two treatments are equally effective (and is
hence negatively phrased). A significance test uses the sample data to assess
how likely the null hypothesis is to be correct.
For example:
'there is no difference in the prevalence of colorectal cancer in patients
taking low-dose aspirin compared to those who are not'
The alternative hypothesis (H1) is the opposite of the null hypothesis, i.e. There is a
difference between the two treatments
The p value is the probability of obtaining a result by chance at least as extreme as

the one that was actually observed, assuming that the null hypothesis is true. It is
therefore equal to the chance of making a type I error (see below).
Two types of errors may occur when testing the null hypothesis
type I: the null hypothesis is rejected when it is true - i.e. Showing a
difference between two groups when it doesn't exist, a false positive. This is
determined against a preset significance level (termed alpha). As the

significance level is determined in advance the chance of making a type I
error is not affected by sample size. It is however increased if the number of
end-points are increased. For example if a study has 20 end-points it is likely
one of these will be reached, just by chance.
type II: the null hypothesis is accepted when it is false - i.e. Failing to spot a
difference when one really exists, a false negative. The probability of making
a type II error is termed beta. It is determined by both sample size and alpha
Study accepts H0 Study rejects H0
Reality H0 Type 1 error (alpha)
Reality H1 Type 2 error (beta) Power (1 - beta)
The power of a study is the probability of (correctly) rejecting the null hypothesis
when it is false
power = 1 - the probability of a type II error
power can be increased by increasing the sample size
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Question stats
A 13%
B 11.9%
C 24.3%
D 42.8%
E 8%

Question 31 of 41
 
A 46 year old man is undergoing a colonoscopy under sedation using a

combination of midazolam and fentanyl sedation. The procedure is complicated by
the development of a significant sigmoid loop and becomes increasingly
uncomfortable. When the endoscope is in the region of the colonic splenic flexure,
the patients asks for the procedure to stop. What is the best course of action?
Administration of additional midazolam and proceeding to complete the

procedure
Withdrawal of the endoscope and arranging an alternative test
Call an anaesthetist to administer an general anaesthetic
Administration of intravenous fentantyl and proceeding to complete the

procedure
Turn the patient prone and complete the procedure
During endoscopic procedures, many patients have conscious sedation and retain
decision making ability. If the request the procedure to be stopped this must be
adhered to.
Next question 
Consent
1. Informed
2. Expressed
3. Implied



Form 3

Form 4
Capacity
Key points include:
Consent in minors
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Question stats
A 9.2%
B 64.6%
C 10.3%

Question 32 of 41
 
A surgical unit are conducting a study to determine whether patients who have
bowel preparation have a lower risk of colonic anastomotic leakage than those
having none. The planned sample size is 25. Which of the tests below is most
appropriate?
Paired T test
Unpaired T test
Fishers exact test
Chi squared test
LSD post hoc test
It is likely to be underpowered with the number provided. However, it would be

possible to classify such data into a 2x2 contingency table. However, when the
sample size is small, the Chi squared test is not suitable and in these situations
the Fishers exact test is used.
Next question 
Statistics
Statistics is a topic that generally strikes fear and dread into most surgeons
hearts. The MRCS is not an examination designed to test mathematical skill but
the examiners do expect you to have working knowledge of commonly used tests
so that you can appraise the literature properly.
Data types
Before selecting a method of statistical analysis it is imperative that the type of
data to be analysed is correctly categorised. Commonly used terms include
nominal, ordinal, interval and continuous.
Term Interpretation
Nominal Data can be allocated a numerical code that is arbitrary. For

example allocating people as alive or dead using codes of 0 or 1
Ordinal data Data using numbers that can be used on a scale. Severity of pain
is often measured in this way
Interval Data is measured numerically. However, the zero point is

scale arbitrary
Continuous Data is measured numerically where the numerical value is a real

number and may be any value. Examples include height and
weight
Analysing data
Having ascribed the data it is then possible to begin the process of analysis.
Nominal data is often tabulated into categories because of the nature of the
underlying data sets. Continuous data may be displayed graphically often as
individual data points. When the sample size is large enough, continuous data can
be analysed to determine the distribution of the data points. Often, but not always
these will be in the form of a gaussian distribution. Determining whether data is
normally distributed or not is key to making sense of the subsequent statistical
tests. Parametric tests are used to test normally distributed data, the T Test is one
of the best examples. Data which is not normally distributed cannot be analysed in
this way and a non parametric test must be used. Examples of such tests include
Chi Squared and Mann Whitney U tests. Chi squared tests often appear in the
medical literature. There are some assumptions that are made in relation to Chi
squared tests; these include the need to use 2 degrees of freedom (usually) and
the minimum sample size. Where the sample size is small then a different test is
appropriate and the Fishers exact test is often used.
In situations where data is normally distributed and paired samples are taken from
the same individuals (such as following an intervention) then the paired T Test
may be used.
Multiple testing and post hoc analysis

In the ideal world statistical analysis is conducted on data that is collected
prospectively according to pre set power calculations and defined end points.
Occasionally, data does not produce an expected outcome or a certain type of
patient appears to have a different result. Subsequent analysis of such groups is
termed a post hoc analysis. This can be perfectly legitimate, alternatively it can
represent the last ditch attempt of a researcher to try and find any aspect of the
data that is worthwhile. This can lead to errors and false rejection of a null
hypothesis. A statistically significant result is more likely to occur if the same
dataset is subjected to multiple analyses. To counteract this problem some
researchers will apply a Bonferroni correction, this adjusts the analysis to allow for
multiple testing.
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Question stats
A 29.1%
B 15.7%
C 29.3%
D 19.7%
E 6.2%
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Question 33 of 41
 
A new test to screen for pulmonary embolism (PE) is used in 100 patients who
present to the Emergency Department. The test is positive in 30 of the 40 patients
who are proven to have a PE. Of the remaining 60 patients, only 5 have a positive
test. What is the sensitivity of the new test?
8.33%
30%
40%
66.66%
75%
A contingency table can be constructed from the above data, as shown below:
PE diagnosed No PE
Test positive 30 5
Test negative 10 55
The sensitivity is therefore 30 / (30 + 10) = 75%
Next question 

Test positive TP FP
Test negative FN TN

result

result
positive
test is negative
Next question 

          
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Question stats
A 9.6%
B 11.5%
C 10.1%
D 19.5%
E 49.3%
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Question 34 of 41
 
A rapid finger-prick blood test to help diagnosis deep vein thrombosis is

developed. Comparing the test to current standard techniques a study is done on
1,000 patients:
DVT present DVT absent
New test positive 200 TP 100 FP
New test negative 20 FN 680 TN
What is the specificity of the new test?
680/880
200/220
680/780
680/700
200/300
Specificity = true negatives / (true negatives + false positives) Sprcificity - Negative

Sensitivity- positve
= 680 / (680 + 100)
Next question 
Test positive TP FP
Test negative FN TN

result

result
positive
test is negative
Next question 

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Question stats
A 10.4%
B 16.7%
C 39.7%
D 18.3%
E 14.8%
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Question 35 of 41
 
A surgical team wish to conduct a meta analysis of randomised controlled trials of

the use of low molecular weight heparins in the prevention of post operative deep
vein thrombosis. How would these results be best displayed graphically?
Forest plot
Box Whisker plot
Violin plot
Kaplan Meier graph
None of the above
Data from multiple RCT's are best displayed using Forest plots. Funnel plots may
be used to determine the effect of small studies and their overall effect on the
data. Violin plots and Box Whisker plots are often used to graphically display non
parametric data from single studies and are not generally used to display data
from meta analyses.
Next question 
Forest plots
A Forest plot is a graphical display designed to illustrate the relative strength of

treatment effects in multiple quantitative scientific studies, addressing the same
question. It is often used to graphically display meta analyses of randomised
controlled trials.
The graph may be plotted on a natural logarithmic scale when using odds ratios or
other ratio-based effect measures, so that the confidence intervals are
symmetrical about the means from each study and to ensure undue emphasis is
not given to odds ratios greater than 1 when compared to those less than 1. The
area of each square is proportional to the study's weight in the meta-analysis. The
overall meta-analysed measure of effect is often represented on the plot as a
vertical line. This meta-analysed measure of effect is commonly plotted as a
diamond, the lateral points of which indicate confidence intervals for this estimate.
A vertical line representing no effect is also plotted. If the confidence intervals for
individual studies overlap with this line, it demonstrates that at the given level of
confidence their effect sizes do not differ from no effect for the individual study.
The same applies for the meta-analysed measure of effect: if the points of the
diamond overlap the line of no effect the overall meta-analysed result cannot be
said to differ from no effect at the given level of confidence.
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Question stats
A 42.2%
B 16.7%
C 8.5%
D 24.2%
E 8.3%
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Question 36 of 41
 
What is the main impact of the Montgomery ruling in consenting patients for
surgical procedures?
It clearly states that all risks however minor with a frequency of 10% or
greater be disclosed
It states whether a reasonable person in the patients position would be

likely to attach significance to the risk, or the doctor is or should
reasonably be aware that the particular patient would be likely to attach
significance to it
It states all procedures should be performed by a consultant
It covers the decision making for minors who need to be consented by

proxy
It replaces the Gillick competency test
The new legal judgement recognises this individual approach to warning patients
about risk. Rather than taking into account the percentage possibility of a risk
arising, doctors need to bear in mind the significance of a given risk for that
particular patient, and the nature of the risk, such as the effect it would have on the
patient's life if it were to occur. The assessment is therefore considered to be both
fact-sensitive and sensitive to the characteristics of the particular patient.
Next question 
Consent
1. Informed
2. Expressed
3. Implied



Form 3

Form 4
Capacity
Key points include:
Consent in minors
Next question 
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Question stats
A 17.3%
B 56.6%
C 7.9%
D 11.2%
E 6.9%
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Question 37 of 41
 
Which of the following statements relating to quantitative data is false?
Discrete data cannot be sub divided
The median is less susceptible to extreme outliers than the mean
The mean is susceptible to extreme outliers
Data that fits the standard distribution perfectly will have a mode that is
half the value of the mean
Values obtained have a numerical scale
Data that fits the standard distribution perfectly will have a mean, median and
mode that are all the same value.
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data.
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A 15.6%
B 13.3%
C 12.1%
D 48.5%
E 10.5%
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Question 38 of 41
 
If a sample is normally distributed which of the following is true?
Mean = standard deviation
Mean = standard error of the mean
Mean = median
Mean = variance
The mode and standard error of the mean have the same value
In a normally distributed sample, the mean, median and mode are the same.
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Normal distribution
The normal distribution is also known as the Gaussian distribution or 'bell-shaped'

distribution. It describes the spread of many biological and clinical measurements
Properties of the Normal distribution

symmetrical i.e. Mean = mode = median
this is often reversed, so that within 1.96 SD of the mean lie 95% of the
sample values
the range of the mean - (1.96 *SD) to the mean + (1.96 * SD) is called the
95% confidence interval, i.e. If a repeat sample of 100 observations are
taken from the same group 95 of them would be expected to lie in that range
Standard deviation
the standard deviation (SD) represents the average difference each
observation in a sample lies from the sample mean
SD = square root (variance)
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Question stats
A 15.2%
B 8.5%
C 58.4%
D 8.4%
E 9.4%
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Question 39 of 41
 
Which of the following tests is most appropriate for correcting against multiple
statistical analyses that might provide an erroneous result (i.e. to correct against
data dredging)?
LSD post hoc test
Bonferroni test
T Test
Fishers test
Spearmans rank test
As more types of side effects are considered, it becomes more likely that the new
drug will appear to be less safe than existing drugs in terms of at least one side
effect. Methods are available to adjust the p value to reflect the multiple
comparisons being made, the aim being to avoid spurious results. A frequently
applied correction is the Bonferroni method in which the observed p values are
multiplied by the number of tests performed, any resulting p value which is greater
than 1 is set to 1 and any which remains at less than 0.05 can be considered
significant at the 5% level.
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data.
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A 11.9%
B 52.6%
C 11.9%
D 13.9%
E 9.8%
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Question 40 of 41
 
Which of the statistical tests listed below is most appropriate to use with data
which follows a normal distribution?
T Test
Fishers exact test
Spearmans rank test
Mann Whitney U test
Bonferroni test
A T Test is most suited to data which follows the normal distribution as the others
are non parametric tests. The Bonferroni test is used to provide correction when
multiple tests are used.
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data.
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Question stats
A 55%
B 13%
C 10.7%
D 11.9%
E 9.4%
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Question 41 of 41
When is it mandatory to involve an independent mental capacity advocate ?
When a patient requires a significant intervention, time permits and the

patient lacks capacity to decide for themselves
When a patient cannot decide on the best treatment
When parents disagree about treatment of a child
When two doctors disagree about the best treatment option
When a patient has lost trust in their clinician
The Mental Capacity Act (MCA) requires doctors to involve an independent mental
capacity advocate (IMCA) for serious medical treatment decisions when:
a best interests decision is required because the doctor has assessed the
person as not having the capacity to make the decision themselves
the person does not have family or friends with whom it is appropriate to
consult about the decision.
Serious medical treatment is defined in the Mental Capacity Act 2005

(Independent Mental Capacity Advocates) (General) Regulations 2006 as
treatment which involves providing, withdrawing or withholding treatment in
circumstances where one or more of the following apply:
in a case where a single treatment is being proposed, there is a fine balance
between its benefits to the patient and the burdens and risks it is likely to
entail for them
in a case where there is a choice of treatments, a decision as to which one
to use is finely balanced
what is proposed would be likely to involve serious consequences for the
patient.
The MCA Code of Practice says that serious consequences may include treatment
options which:
cause serious and prolonged pain, distress or side effects have potentially
major consequences for the patient (for example, major surgery or stopping
life-sustaining treatment)
have a serious impact on the patients future life choices.
Consent
1. Informed
2. Expressed
3. Implied


Form 3

Form 4
Capacity
Key points include:
Consent in minors
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B 10.6%
C 11.9%
D 8.1%
E 7.5%
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Management - Legal Issues

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Question 1 of 41

Undertake a clinical audit

Undertake a clinical review

Undertake a service evaluation

Discuss the case with the ethics committee

Discuss selected cases at joint histopathology meetings

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Audit and Research

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 Open MRCS Part A textbook (../review/textbook.php)

A surgical department wishes to determine whether it is using types of prosthetic

System based audit

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reliability of financial data

Operational A future-oriented, systematic, and independent evaluation of

Departmental A current period analysis of administrative functions, to

Standards Comparison of care or passage of care against set and

Systems Evaluation of processes occurring within an institution.

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In medical statistics, which of the following does a p value of 0.04 represent?

Risk of type 1 Error

Risk of type 2 Error

Size of power of the study

Number of degrees of freedom

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Type 1 Error Test rejects true null hypothesis

Type 2 Error Test fails to reject a false null hypothesis

38.1% of users answered this question correctly

 Open MRCS Part A textbook (../review/textbook.php)

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Incidence and prevalence

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54.5% of users answered this question correctly

 Open MRCS Part A textbook (../review/textbook.php)

What is the reciprocal of absolute risk reduction?

Number needed to treat

None of the above

In epidemiology, the absolute risk reduction, or risk difference is the decrease in

Please rate this question: NNT=1/ARR

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Absolute risk reduction

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47.7% of users answered this question correctly

 Open MRCS Part A textbook (../review/textbook.php)

LSD post hoc test

Chi squared test

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Nominal Data can be allocated a numerical code that is arbitrary. For

Interval Data is measured numerically. However, the zero point is

Continuous Data is measured numerically where the numerical value is a real

Multiple testing and post hoc analysis

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43.4% of users answered this question correctly

 Open MRCS Part A textbook (../review/textbook.php)

A consultant surgeon is undertaking increasingly complex neonatal surgery.

Review the cases at the next mortality and morbidity meeting