? Use audit to the benefit of your patients.
? Develop soundly based audit projects.
? Introduction to the basics of surgical research.
Introduction
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? We are continuously being scrutinized.
? Living in the era of evidence based medicine and accountability.
? Must show that our standard of practice is satisfactory.
? Research and audit are processes by which evidence is developed.
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? Audit generates information related to performance- both individualand collective.
Case 1
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? You have discovered that over
? Key issues
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the last year there has been a 2? Patient scoring systems.
fold increase in the mortality of
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patients operated in your unit.
? Case mix alterations process and
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outcome audit? Structure.
Audit has been divided:
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vMedical audit :An audit undertaken by doctors and consists of a review of
clinical events.
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vClinical audit :
A review of all potential medical events surrounding the
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treatment of a patient. This wil include nursing, physiotherapy,social aspects, etc.
Surgical Audit ? What is it and why do it?
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? The purpose of audit is to examine whether what you think is
happening really , and whether current performance meets existing
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standards? Critical study of all aspects of patient care.
? May address economy, efficiency and effectiveness.
? Covers structure, process and outcomes.
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? Ultimate goal is improving the quality of care for patients.? Stimulus and source of material for learning and quality improvement.
The aims of audit are:
? To identify ways of improving and maintaining the quality of care for
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patients;
? To assist in the continuing education of surgeons;
? To help make the most of resources available for the provision of
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surgical services.
Forms of Audit
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? Total Practice or Workload Audit: covers all the surgical operationsperformed.
? Selected Audit from Surgical Practice: covers all patients who
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undergo a selected procedure.
? A Clinical Unit Audit: conducted by a clinical unit in which individual
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surgeons may participate.? Group or Specialty Audit: an audit conducted by or under the
auspices of a group or Specialty Society.
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? A Focused Audit: : e.g. what is the wound infection rate after large
bowel surgery.
Surgical Audit and Continuing Professional
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Development
? Regarded as a cornerstone of professional development.
? Only by looking objectively at our own practice of surgery will we be
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able to compare our current proficiency and discover how to improveon this for the sake of our patients.
? Audit can help identify the difference between what surgeons think
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they are doing and what they actually do.
The Surgical Audit Cycle
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? Surgical audit activities are based on a five-step cycle:Make
changes and
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Determine
monitor
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scopeprogress
Interpret
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Select
results with
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standardspeer review
Collect data
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? Step 1 Determine scope:? A thoughtful decision about which area(s) of surgical practice to review.
? Step 2 Select standards:
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? A clear description of what is good practice in this area against which the results of the
audit wil be compared.
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? Step 3 Col ect data:? The collection of relevant data.
? Step 4 Present and interpret results with peer review:
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? Comparison of results to standards , discussion with peers, decision about what changes
may lead to improvement e.g. learning new skil s, changes in practice, systems etc.
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? Step 5 Make changes and monitor progress:? Alteration of practice in accord with the results and then checking that improvement has
occurred.
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Common topics for audit:
? 30 day mortality and significant morbidity;
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? length of hospital stay;? unplanned readmission or re-operation rates;
? positive and negative outcomes;
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? operation-specific complications;
? process of care, such as pre-operative care;
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? time on waiting list;? numbers waiting for outpatient appointment;
? use of investigations;
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? justification of management; and
? patient satisfaction.
How to select standards?
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? use evidence-based research and guidelines;
? adapt existing local guidelines for local relevance;
? use an accessible library for evidence about effective practice and
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develop new guidelines; and/or? look to your specialty group to define standards.
Col ect Data
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? what data you wil collect, and how you wil collect it.
? The most important principle here is to ensure that you collect quality data.
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? Consider the following questions to help decide on the best quality assessment method:? What information is necessary to answer the audit question(s)?
? From whom wil it be collected?
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? Should it be collected prospectively or retrospectively?
? How wil it be collected?
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? During or after the operation, on a PDA, on a computer, on a form, or by questionnaire,and by whom?
? How wil follow up data be collected?
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? By record review, by patient follow-up questionnaire, through the GP, by phone cal , or
by review of routine data, and by whom?
? How will the cases for review in a prospective project be identified or
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selected?
? All patients, random selection, consecutive operations, all patients on
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the same day each week, or checklist to determine eligibility?? How will the cases in a retrospective review be identified or
selected?
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? From a register, medical records data, review of referrals, or from
previous
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? appointment schedules?Present and Interpret Results with Peer
Review
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? The results of your audit should be presented at a clinical meeting.? Peer review is a learning exercise. It is not an opportunity to blame or
brag.
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? Involves an evaluation of one's work by one's peers.? Peers are other surgeons with comparable training and experience.
Make Changes and Monitor Progress
? The next step is to implement any changes that are recommended.
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? Implementation involves not just making changes but ensuring thateveryone involved is educated/ informed as to what changes are
being made and why.
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? The impact/ effects of the changes made then needs follow up action.
What Makes for Effective Audit?
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? Promotion of a culture of audit? Al ocate time and resources
? Oversee and verify data col ection
? Productive peer review
What Opportunities Arise from Surgical
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Audit?
? Educational opportunities
? Systemic improvement opportunities
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What Resources are Required for SurgicalAudit?
? Manual systems
? Computer systems
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? LogbooksSurgical research
What is Research ?
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? Branch of medical science that determines the safety andeffectiveness of medications, devices, diagnostic products and
treatment regimens intended for human use.
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?used for prevention, relieving symptoms of a disease.
Quantitative vs. Qualitative research
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Quantitative:
Qualitative:
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Designed to test a hypothesis.Identifies themes following established
methodology.
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May involve evaluating or comparing
Usual y involves studying how
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interventions, particularly new ones.interventions and relationships are
experienced.
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Study design may involve al ocating
Uses a clearly defined sampling
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patients to intervention groups.framework underpinned by conceptual
or theoretical justifications.
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Research vs. Clincal Audit
Research:
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Clinical audit:? May involve experiments on human Never involves experiments, whether
subjects, whether patients, patients on healthy volunteers, or patients as
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as volunteers, or healthy volunteers. volunteers? Is a systematic investigation which ? Is a systematic approach to the peer
aims to increase the sum of
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review of medical care in order to
knowledge
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identify opportunities forimprovement.
? May involve allocating patients
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? Never involves allocating patientsrandomly to different treatment
randomly to different treatment
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groups.
groups
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Research:
Clinical audit:
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? May involve a completely new? Never involves a completely new
treatment.
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treatment
? May involve extra disturbance or work ? Never involves disturbance to the
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beyond that required for normalpatients beyond that required for
clinical management.
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normal clinical management
? Usually involves an attempt to test a
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? May involve patients with the samehypothesis.
problem being given different
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treatments, but only after fulldiscussion of the known advantages
and disadvantages of each treatment.
? May involve the application of strict
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? The patients are allowed to choose
selection criteria to patients with the
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freely which treatment they get.same problem before they are entered
into the research study.
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? Scientific Research asksAre we doing the right operation ?
?Audit Research asks
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Are we doing the operation right ?
Types of study:
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1) Observational
2) Case-control
3) Cross-sectional
4) Longitudinal
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5) Experimental6) Randomized
7) Randomized controlled
1) Observational study:
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? Evaluating results of condition or treatment in a defined
population.
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?Retrospective: analyzing past events?Prospective: collecting data contemporaneously.
2) Case-control study:
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?Series of patients with a particular disease or condition
contrasted with matched control patients.
3) Cross-sectional study:
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?Measurements mode on a single occasion, not looking
at whole population but selecting small similar group &
expanding results.
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4) longitudinal study:
?Measurements are taken over a period of time, not
looking at whole population but selecting small similar
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group & expanding results.5) Expermintal study:
?Two or more treatments are compared. Allocation to
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treatment groups is under the control of the researcher.6) Randomised study:
?Two randomly allocated treatments.
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7) Randomised control ed study:
?control group with No treatment.
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?GOLD STANDARD.Types of study
Type of study
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Definition
Observational
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Evaluation of condition or treatment in adefined population
Case - control
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Series of patients with a particular
disease or condition compared with
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matched control patients .Cross ? sectional
Measurements made on a single occasion
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, not looking at the whole population but
selecting a smal similar group and
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expanding resultsLongitudinal
Measurements are taken over a period of
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time , not looking at the whole
population but selecting a smal similar
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group and expanding resultsExperimental
2 or more treatment are compared
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Randomised
2 randomly al ocated treatment
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Randomised contrlolledInclude a control group with standard
treatment Gold standard
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Sample size
?Calculating the number of patient required to perform a
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satisfactory investigation is a very important prerequisite to the
study.
?An incorrect sample size is probably the most frequent reason
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for research to be invalid.
?Never forget that more patients wil need to be randomized than the final sample size to
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take into account patients who die, drop out or are lost to fol ow up.Types of error:
vType I:
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Benefit is perceived when really there is none (falsepositive).
vType II:
Benefit is missed because the study has small numbers
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(false negative).v The Eliminating bias:
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?Blinded observer:? The observers or recorders who do not know which treatment
has been used.
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?Single blind:
? The patient is unaware of the treatment allocation.
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?Double blind:? Neither patient nor researcher is aware of which therapy has
been used until after study has finished, & these are the best
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randomized studies.Confidence Interval "CI"
?Confidence intervals are used to indicate the reliability of an
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estimate.
?Depends on p value.
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P value:
?The probability that results (difference between groups) of
this magnitude would be observed if the null hypothesis is
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true .?The lower the p-value the more strongly you can reject the
hypothesis .
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? If p value is small (<5%) probability of obtaining observeddifference by chance alone is low ? HO rejected.
? If p value is large it is conceivable that data are consistent with
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HO ,which cannot be rejected.
Evidence based surgery:
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?Surgical practice has been considered an art, ask 50
surgeon how to manage a patient and one will get 50 different
answers .
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?is a move to find the best ways of managing patients usingclinical evidence from collected studies.
v Levels of evidence:
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?Evidence grade I:? (High)The described effect is plausible, precisely quantified and
not vulnerable to bias.
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?Evidence grade II:
? (Intermediate) the described effect is plausible but is
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not quantified precisely or may be vulnerable to bias.?Evidence grade III:
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? (Low): concerns about plausibility or vulnerability tobias severely limit the value of the effect being
described and quantified.
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The Cochrane Col aboration:
vAn international not-for-profit and independent organization, of
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over 27,000 contributors from more than 100 countries .vIt produces and disseminates systematic reviews of healthcare
interventions and promotes the search for evidence in the form
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of clinical trials and other studies of interventions.vThe Cochrane Collaboration was founded in 1993 and named
after the British epidemiologist, Archie Cochrane.
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