Surgical Laws

What is the opposite of relative risk?
A. P value
B. Odds ratio
C. Likelihood ratio
D. Absolute risk reduction
E. Number needed to treat
Theme from September 2012 Exam

The number needed to treat is the average number of patients who need to be treated
to prevent one adverse outcome. It is is the inverse of relative risk (absolute risk
reduction). The high the NNT value is, the less effective the treatment. The ideal NNT
is 1.
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%
What is the reciprocal of absolute risk reduction?
A. Odds ratio
B. Number needed to treat
C. False positive
D. False negative
E. None of the above
Similar theme to September 2011 Exam
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.
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.
Number needed to treat

Definition: how many patients would be need to receive a treatment to prevent one
event. It is the absolute difference between two treatments.
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?
A. Incidence
B. Bayesian factor
C. Prevalence
D. Denominator data
E. P value
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 of 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
In medical statistics, which of the following does a p value of 0.04 represent?
A. Risk of type 1 Error
B. Risk of tye 2 Error
C. Size of power of the study
D. Sample size
E. 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.
Statistical error
Type 1 Error  Test rejects true null hypothesis

 Rate of type 1 error and 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 give value of β
 It is related to the power of the test
Which of the following statements relating to quantitative data is false?
A. Discrete data cannot be sub divided
B. The median is less susceptible to extreme outliers than the mean
C. The mean is susceptible to extreme outliers
D. Data that fits the standard distribution perfectly will have a mode that
is half the value of the mean
E. 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.
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.
Theme: Consent
A. Consent the patient

B. Consent the parents
C. Proceed without consent
D. Refer the matter to a court
E. Do not proceed with treatment
F. Consent by proxy
For each of the scenarios given please select the most appropriate course of action.
Each option may be used once, more than once or not at all.
6. 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.
Proceed without consent
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.
7. A 17 year old male motorcyclist is injured in a road traffic accident. He is

brought to the emergency department comatose. He becomes
haemodynamically unstable and a ruptured spleen is diagnosed. A laparotomy is
proposed.
You answered Proceed without consent
The correct answer is Consent by proxy
In this situation it is not possible to wait until the patient regains capacity and
therefore consent by proxy is the best way forward. If time permits it is
desirable for two separate clinicians (one of whom should be of consultant
status) to agree.
8. A 15 year old girl presents with right iliac fossa pain. She becomes
progressively tachycardic and a ruptured ectopic pregnancy is suspected. She is
deemed to be mentally competent and will agree to surgery, but not if her
parents are informed.
Consent the patient
Since she is likely to be Gillick competent she can consent for herself.
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 where
Form 1 consciousness is impaired
Consent For an adult consenting on behalf of a child where consciousness is
Form 2 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
Bolam test
Considers whether a doctor's decision matches the opinion of a responsible body of
doctors skilled in the same practice.
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?
A. Forest plot
B. Box Whisker plot
C. Violin plot
D. Kaplan Meier graph
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.
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.
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 200 100
New test negative 20 680
What is the specificity of the new test?
A. 680/880
B. 200/220
C. 680/780
D. 680/700
E. 200/300
Specificity = true negatives / (true negatives + false positives)
= 680 / (680 + 100)
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 have
value the condition if the diagnostic test is
negative
Likelihood ratio for a sensitivity / (1 - How much the odds of the disease increase
positive test result specificity) when a test is positive
Likelihood ratio for a (1 - sensitivity) / How much the odds of the disease decrease
negative test result specificity when a test is negative
Positive and negative predictive values are prevalence dependent. Likelihood ratios
are not prevalence dependent
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?
A. 8.33%
B. 30%
C. 40%
D. 66.66%
E. 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%
table as below:

Test positive TP FP
Test negative FN TN

negative
Theme: Consent processes
A. Consent form 1 (competent adult)

B. Consent form 2 (procedure on a child)
C. Consent form 3 (procedure on a child or adult where conciousness not
impaired)
D. Consent form 4 (Undertaking procedure where patient lacks capacity)
E. Verbal consent will suffice
F. Research consent form
Please select the most appropriate consent modality for the procedure described. Each
option may be used once, more than once or not at all
12. A 65 year old patient has a wound which is discharging following a

laparotomy. The wound is closed with clips and underlying this is a small
superficial collection measuring 2x3cm.
You answered Consent form 3 (procedure on a child or adult where

conciousness not impaired)
The correct answer is Verbal consent will suffice
This is done on the ward and is a straightforward procedure. Written consent is

not required.
13. An 18 year old male has appendicitis and requires an appendicectomy.
You answered Consent form 3 (procedure on a child or adult where

conciousness not impaired)
The correct answer is Consent form 1 (competent adult)
The patient is 18 so technically an adult where consent is concerned.
14. A 10 year old boy requires removal of a toe nail which has become ingrown
and infected. He does not want the operation performed.
You answered Consent form 2 (procedure on a child)
The correct answer is Consent form 3 (procedure on a child or adult

where conciousness not impaired)
He is a minor.
Consent
1. Informed
2. Expressed
3. Implied

Form 2 impaired
Form 3
Form 4
Capacity
Key points include:
Bolam test
A group of 60 patients with a history of appendicitis is matched to a group of 60
control patients with no history of appendicitis. Thirty of the patients who've had
appendicitis had gastroenteritis in the previous year before compared to only 10 in the
control group.
What is the odds ratio of developing appendicitis for people who have had
gastroenteritis in the previous year?
A. 0.3
B. 3
C. 5
D. 2.5
E. 3.33
Remember to calculate the odds, rather than risk, initially:
Odds of patient with appendicitis having gastroenteritis in the past year = 30 / 30 =

1.0
Odds of the control group having gastroenteritis in the past year = 10 / 50 = 0.2
The odds ratio therefore = 1 / 0.2 = 5
Odds ratio
In studies with binary results (e.g. yes or no) the odds ratio or relative risk is used. OR
rate of 1 implies that event may occur on either group, values of more or less than 1
indicate a skew to one group or the other. The risk ratio is 1 where the event may
occur in either group or less than 1 if it is more likely in one group over the other.
Odds are a ratio of the number of people who incur a particular outcome to the
number of people who do not incur the outcome. The odds ratio may be defined as the
ratio of the odds of a particular outcome with experimental treatment and that of
control.
Odds ratios are the usual reported measure in case-control studies. It approximates to
relative risk if the outcome of interest is rare.
Total number of patients Achieved 50% pain relief

Paracetamol 60 40
Placebo 90 30
The odds of achieving significant pain relief with paracetamol = 40 / 20 = 2
The odds of achieving significant pain relief with placebo = 30 / 60 = 0.5
Therefore the odds ratio = 2 / 0.5 = 4
Which one of the following statements best describes a type II statistical error?
A. The p value fails to reach statistical significance
B. The alternative hypothesis is rejected when it is false
C. The null hypothesis is rejected when it is true
D. The null hypothesis is accepted when it is false
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
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?
A. Randomised controlled trial
B. Cross-over trial
C. Cross-sectional survey
D. Case-control study
E. Cohort study
As sudden infant death syndrome is relatively rare a case-control design is more

appropriate than a cohort study.
Study design
The following table highlights the main features of the main types of study:
Randomised Participants randomly allocated to intervention or control group (e.g.

controlled trial 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 condition
study (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
Which of the following has the greatest impact on the positive predictive value of a
test?
A. Prevalence
B. Subjects who are true negatives
C. Specificity
D. Relative risk
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.
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

Considering cluster randomised trials, which of the following statements is false?
A. They consider interventions targeted at groups
B. They require increased recruitment to achieve the same level of

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

obtained
D. They are less prone to unit of analyses errors than trials involving
individual observations
E. 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.
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
Theme: Timing of surgery
A. Immediate surgery
B. Surgery within 2 hours
C. Surgery within 6 hours
D. Surgery within 24 hours
E. Surgery within same hospital admission
F. Urgent elective surgery within 4 weeks
G. True elective surgery
For each procedure please select the most appropriate time interval for surgery. Each
option may be selected once, more than once or not at all.
20. A 43 year old women is admitted with acute cholecystitis, her USS confirms
the diagnosis and LFT's are normal. It is now 10 hours since admission.
You answered Surgery within same hospital admission
The correct answer is Surgery within 24 hours
Ideal case for acute cholecystectomy. This will enable prompt discharge and
facilitate recovery. Whilst expedient surgery is desirable an emergency
procedure is not justified.
21. A 5 year old boy is admitted with a suspected acute appendicitis. He has
tenderness but no guarding as yet. He requires appendicectomy.
You answered Surgery within 24 hours
The kind of case that can wait till the following day if presenting out of hours.
Appendicectomy may be deferred where peritoneal signs are absent. Where
tenderness and guarding are present a more urgent approach is warranted.
22. A 72 year old man is admitted with large bowel obstruction. He has been
vomiting for 24 hours and his caecum is tender and measures 11cm.
You answered Immediate surgery

The sun should not rise and set on unrelieved large bowel obstruction! This
patient has a competent ileocaecal valve. As a result lack of surgery would
result in caecal perforation leading to faecal peritonitis with and associated
high mortality rate.
Preparation for surgery
Elective and emergency patients require different preparation.
Elective cases
 Consider pre admission clinic to address medical issues.

 Blood tests including FBC, U+E, LFTs, Clotting, Group and Save
 Urine analysis
 Pregnancy test
 Sickle cell test
 ECG/ Chest x-ray
Exact tests to be performed will depend upon the proposed procedure and patient
fitness.
Risk factors for development of deep vein thrombosis should be assessed and a plan
for thromboprophylaxis formulated.
Diabetes
Diabetic patients have greater risk of complications.
Poorly controlled diabetes carries high risk of wound infections.
Patients with diet or tablet controlled diabetes may be managed using a policy of
omitting medication and checking blood glucose levels regularly. Diabetics who are
poorly controlled or who take insulin will require a intravenous sliding scale.
Potassium supplementation should also be given.
Diabetic cases should be operated on first.
Emergency cases
Stabilise and resuscitate where needed.
Consider whether antibiotics are needed and when and how they should be
administered.
Inform blood bank if major procedures planned particularly where coagulopathies are
present at the outset or anticipated (e.g. Ruptured AAA repair)
Don't forget to consent and inform relatives.
Special preparation
Some procedures require special preparation:
 Thyroid surgery; vocal cord check.

 Parathyroid surgery; consider methylene blue to identify gland.
 Sentinel node biopsy; radioactive marker/ patent blue dye.
 Surgery involving the thoracic duct; consider administration of cream.
 Pheochromocytoma surgery; will need alpha and beta blockade.
 Surgery for carcinoid tumours; will need covering with octreotide.
 Colorectal cases; bowel preparation (especially left sided surgery)
 Thyrotoxicosis; lugols iodine/ medical therapy.
References
Management of adults with diabetes undergoing surgery and elective procedures.
NHS Diabetes. April 2011.
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?
A. 2.5
B. 25
C. 4
D. 40
E. 5
There is an absolute risk reduction of 15-12.5%= 2.5% for treatment A

Therefore the NNT = 1/0.025 = 40
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.
Number needed to treat

Definition: how many patients would be need to receive a treatment to prevent one
event. It is the absolute difference between two treatments.
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?
A. 0.8
B. 0.66
C. 0.33
D. 0.1
E. Cannot be calculated
A contingency table can be constructed from the above data, as shown below:
Colorectal cancer No colorectal cancer

Test positive 40 20
Test negative 10 430
Positive predictive value = TP / (TP + FP) = 40 / (40 + 20) = 0.66
table as below:

Test positive TP FP
Test negative FN TN

negative
Which of the following most closely describes the risk of a type I statistical error?
A. Power calculation
B. P value
C. Odds ratio
D. Relative risk
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.
Power calculations and statistical error
Statistical error
Type 1 A test rejects a true null hypothesis. Analogus to false positive. It usually
Error 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 of a
Error 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.
Which of the following statements relating to randomised controlled trials is false?
A. Consist of a control group recruited during the same time interval as

the treatment group.
B. Are not applicable to retrospectively analysed data even if captured
on a prospectively created database.
C. They require concealment of treatment throughout the duration of the

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

controlled trials.
This statement is true of a blinded study. Concealment of allocation is an important

part of RCT's as knowledge of likely allocated procedure may well affect compliance
rates.
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.
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?
A. Odds ratio
B. Experimental event rate
C. Relative risk
D. Absolute risk increase
E. Numbers needed to harm

Cohort studies -
relative risk
Study design
The following table highlights the main features of the main types of study:
Randomised Participants randomly allocated to intervention or control group (e.g.
controlled trial 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 condition
study (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
Which of the following statements relating to consenting patients for surgery is false?
A. Cosent should be taken by a person who has sufficient knowledge of

the procedure
B. All risks with a frequency of 1 in 500 or greater must be disclosed
C. Patients who have recieved sedating pre medication may no longer be

able to provide informed consent
D. Written consent is required for procedures performed under local

anaesthesia
E. Where a procedure (or part thereof) consists of research this should be

recorded on a separate research consent form
Generally risks with an incidence of 1% or greater are disclosed. Exceptions to this

are where a rarer complication is particularly serious.
Consent
1. Informed
2. Expressed
3. Implied

Form 2 impaired
Form 3
Form 4
Capacity
Key points include:
Bolam test
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?
A. V
B. I
C. II
D. III
E. IV
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)
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)
 Theme: Audit
A. Standards based audit

B. Departmental review
C. Systems based audit
D. Operational audit
E. Financial audit
F. Peer review

Please select the most appropriate type of audit method for the situation
described. Each option may be used once, more than once or not at all.
30. 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".
Systems based audit
Theme from April 2012 Exam

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.
31. A group of surgeons wish to determine whether patients are recieving adquete
deep vein thrombosis prophylaxis following surgery.
You answered Departmental review
The correct answer is Standards based audit
This type of audit is widely undertaken in most trusts in the UK.
32. Surgeons are becoming increasing concerned about the adverse results of Mrs
X performing a new an innovative operative procedure not widely practised
elsewhere.
Peer review
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.

 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, thorugh 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 evaluate the
review 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 widely agreed
based audit standards or outcomes.
Systems based Evaluation of processes occurring within an institution.
audit

Systems based audits are an integral part of the process of clinical governance.
 Theme: Statistics in surgery
A. Mann Whitney U test

B. Analysis of variance
C. LSR post hoc test
D. Bonferroni test
E. Kruskall Wallis test
F. T Test

Please select the most appropriate statistical test for the situation described.
Each option may be used once, more than once or not at all.
33. We wish to determine whether there are significantly more patients in a

surgical unit presenting with post appendicectomy wound infections than there
were one year previously.
You answered Bonferroni test
The correct answer is T Test
This will involve the comparison of absolute numbers of patients and therefore
this can be assessed using a T -Test. It does make the assumption that the data
is normally distributed. However, the other tests would not be suitable.
34. We want to make multiple comparisons of different types of side effects of a

new drug.
You answered Kruskall Wallis test
The correct answer is Bonferroni 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.
35. 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.
You answered LSR post hoc test
The correct answer is 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.

 Qualitative and quantitative data


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.
 Theme: Governance issues
A. Clinical audit
B. Service evaluation
C. Refer to research ethics committee
D. Implement procedure with no further monitoring
E. Cease activity and refer individual to GMC
F. Cease activity and undertake full service evaluation
G. Obtain written consent from each participant

For the following research/ audit scenarios please select the most appropriate
governance modality. Each option may be used once, more than once or not at
all.
36. A general surgical unit has become increasingly concerned about the
behaviour of consultant Slasher. Over the past 48 months he has persisted in
performing neonatal tracheoesphageal fistula repairs. Unfortunately he has
resisted efforts to prevent him from undertaking these unsupervised. 2 more
babies die and the Chief Executive would like your guidance.
You answered Cease activity and undertake full service evaluation
The correct answer is Cease activity and refer individual to GMC
While most surgical and departmental problems can be handled in house is can
be seen that this approach has been tried and failed. Given the deaths there is
no other option than E
37. 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
You answered Service evaluation
The correct answer is Clinical audit
Where there are clear guidelines, an audit is the best measure.
38. A surgeon wishes to undertake some laboratory research into the migratory
behaviour patterns of metastatic colorectal cancer cells. These will be
harvested from patients who are undergoing hepatic resection of metastatic
colorectal cancer; apart from diseased tissue no other samples will be taken.
You answered Obtain written consent from each participant
The correct answer is Refer to research ethics committee
Whenever patient tissue is taken for research it is necessary practice to gain

ethics approval. Some units may have blanket policies in place for taking
tissue for research to tissue banks but as a general rule most people should
seek ethics approval PRIOR to starting research.

 Audit and Research

Clinical audit
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.
 Which one of the following is equivalent to the pre-test probability?
A. Post test odds / (1 + post-test odds)
B. Pre-test odds x likelihood ratio
C. The prevalence of a condition
D. The incidence of a condition
E. 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.
 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)
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?
A. 95.4%
B. 5.3%
C. 98.3%
D. 10%
E. 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.
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)
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?
A. 95.4%
B. 5.3%
C. 98.3%
D. 10%
E. 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.
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)
 In Intention to treat analysis, which statement is untrue?
A. It is based on the initial treatment intended.
B. Excludes those who cross over to alternative treatment arms of a trial.
C. Is different from a per protocol analysis.
D. Will affect the statistical power calculation to compare outcomes of

treatment.
E. Helps to minimise observer bias.


It includes those who cross over which is how it helps provide additional
information relating to those groups.
 Audit and Research

Clinical audit
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.
 Which of the following is not usually required to make a power calculation?
A. The specificity of the intervention being tested
B. The desired significance level
C. The size of the effect being measured
D. The desired power value
E. 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
 Power calculations and statistical error

Statistical error
Type 1 A test rejects a true null hypothesis. Analogus to false positive. It usually
Error 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 of a
Error 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.
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?
A. 0.8
B. 0.2
C. 1.66
D. 0.6
E. 0.06
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
Total number of patients Experienced significant pain relief

Paracetamol 100 60
Placebo 80 20
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%
Which of the following statements relating to audit and governance is untrue?
A. An audit standard is a threshold of compliance with an audit

criterion
B. Sample size calculations are an important part of audit

planning
C. Clinical audit is part of clinical governance
D. Audits should be performed regularly when a novel surgical

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

practice or capacity
6 pillars of clinical
governance:
Clinical effectiveness
Research and
development
Openess
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.
Audit and Research
Clinical audit
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.
Which of the following statements relating to qualitative data is false?
A. The data has no true numerical scale
B. It may comprise multiple data groups
C. May be reported using odds ratios
D. May be reported using frequency histograms
E. 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.

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.
Which of the following statements is false in relation to consent?
A. All adults by law are assumed to be competent

B. The Bolam test defines if a patient has capacity or not
C. Consent 2 is the form signed by parents on behalf of their children
D. Implied consent is a form of consent
E. 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.
Consent
1. Informed
2. Expressed
3. Implied

Form 2 impaired
Form 3
Form 4
Capacity
Key points include:
Bolam test

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What is the opposite of relative risk?

D. Absolute risk reduction

E. Number needed to treat

Theme from September 2012 Exam

 EER = rate at which events occur in the experimental group

Total number of patients Experienced significant pain relief

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

Relative risk reduction (RRR) or relative risk increase (RRI) is calculated by

B. Number needed to treat

E. None of the above

Similar theme to September 2011 Exam

Absolute risk reduction

Number needed to treat

Incidence and prevalence

 prevalence = incidence * duration of condition

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

A. Risk of type 1 Error

B. Risk of tye 2 Error

C. Size of power of the study

E. Number of degrees of freedom

Type 1 Error  Test rejects true null hypothesis

Type 2 Error  Test fails to reject a false null hypothesis

Which of the following statements relating to quantitative data is false?

A. Discrete data cannot be sub divided

B. The median is less susceptible to extreme outliers than the mean

C. The mean is susceptible to extreme outliers

E. Values obtained have a numerical scale

Qualitative and quantitative data

Qualitative and quantitative data

Since quantitative data is based on a numerical scale it can be organised to create a

A. Consent the patient

Proceed without consent

7. A 17 year old male motorcyclist is injured in a road traffic accident. He is

You answered Proceed without consent

The correct answer is Consent by proxy

Consent the patient

There are 3 types of consent:

Consent forms used in UK NHS

B. Box Whisker plot

D. Kaplan Meier graph

E. None of the above

A Forest plot is a graphical display designed to illustrate the relative strength of

DVT present DVT absent

What is the specificity of the new test?

Specificity = true negatives / (true negatives + false positives)

= 680 / (680 + 100)

Screening test statistics

TP = true positive; FP = false positive; TN = true negative; FN = false negative

Disease present Disease absent

Sensitivity TP / (TP + FN ) Proportion of patients with the condition

{PE diagnosed} {No PE}

The sensitivity is therefore 30 / (30 + 10) = 75%

Screening test statistics

TP = true positive; FP = false positive; TN = true negative; FN = false negative

Disease present Disease absent

Sensitivity TP / (TP + FN ) Proportion of patients with the condition

A. Consent form 1 (competent adult)

12. A 65 year old patient has a wound which is discharging following a

You answered Consent form 3 (procedure on a child or adult where

This is done on the ward and is a straightforward procedure. Written consent is

13. An 18 year old male has appendicitis and requires an appendicectomy.

You answered Consent form 3 (procedure on a child or adult where