Block 12 Flashcards
name the 5 big CAMs
Chiropractic Osetopathy Acupuncture Herbal medicine Homeopathy
Most used CAM
Chiropractic
least used CAM
Homeopathy
Which 2 CAMs have statutorys regulation of professionals
Chiropractic
Osteopathy
Number of people using chiropracters a year
7.5 million
Number of people using acuptuncture a year
3.1 million
Number of people using homeopathy a year
1.3 million
3 ways people can access CAMS?
Self-referral
GP referral
NHS professional referral
Most common way of accessing CAMS
Self-referral (70%)
What % of CAMs use if GP referal
17%
Ways of financing CAMs
Self
NHS
Other
What % of CAMs is financed on NHS
14%
CAMS is mostly accessed through what and funded through what?
Self-referral
Self funding
68% of CAMS is used for what kinds of problem:
MSK
Effectiveness gap =
An area where there is a lack of efficacy for treatment
What % of people believe there is an effectiveness gap for msk problems?
95%
The key principles that underline CAM use for msk problems can be shown by what model?
Biopsychosocial model
biological side of CAMs:
Manipulation Moblisation Massage Guided movement Acupuncture
Psychological aspects of CAMs
Communication
Compassion
Changing beliefs/perceptions
Promote self-efficacy
Social aspects of CAMs
Advice on adjustments
Promote back to work
NICE guidelines for lower back pain:
- Don’t offer acupuncture
- Consider manual therapy (massage, manipulation)
Why don’t NICE offer acuptuncture for LBP?
> 0.5 placebo effect with sham needling
NICE guidelines for headache:
- Consider course of 10 sessions of acupuncture for chronic tension-type headache
NICE guidelines for osteoarthritis =
- Do not offer acupuncture
- Manipulation and stretching core treatments
Why do we need research ethics?
Historical examples
Social and political trends towards increased autonomy
Legislation
Research ethics codes
Historical examples of why we need research ethics =
Nazi medical experiments
Tuskegee syphilis study
Alderhey
Wakefield
Name some legislations which are related to research ethics involving humans/human tissues
Human Rights Act
Human tissues act
Name 2 research ethics codes of conduct
Numremberg Code
Helsinki declaration
Nuremberg code comprises a set of principles concerning research with
Humans
Nuremberg code states that research with humans should be:
- Voluntary consent
- Avoid all unneccessary physical and mental suffering
- Be done by scientific qualified persons
Helsinki declaration requires what
Any form of human research to be subject to independent ethical review
Why is human research more tricky than some others?
Need for consent
Respect autonomy
Reduce harm
Which research subjects are important in research ethics?
Vulnerable - children, mentally ill, reduced capacity
6 key principles of research ethics =
- Usefulness
- Necessity
- Risk
- Consent
- Confidentiality
- Approval
Usefulness =
Is the study likely to find something new?
Necessity =
Does the study need to be done on humans/this particular group?
Risk in research should be
Minimised, outweighed by potential benefits
Consent =
Getting permission from a person before involving them in research project
Why is consent important?
- Respects patients autonomy
- Less likely to cause harm
Consent must be
Informed
Voluntary
How can we aid informed consent?
Giving patient information sheets
How to facilitate consent =
Patient info sheet Clear, avoid jargon Summary of key points Time for patient to ask questions TIme to think about/decide
Human tissues act =
Consent for stoarge and use of tissue for ‘schedules purposes’ required for tissue from living or deceased persons
Why is confidentiality important?
Autonomy
Aids good care
Reduces harm - stops info getting in hands of wrong people
- Trust
Guidlines for confidentiality in research =
- All info confidential
- Anonmyised/coded
- Stored securely
- Accessed on need to know
When is research ethics approval needed?
Humans
Human tissue
Personalised data
When is research ethics not normally needed?
Clinical audit
Service evaluations
Why do we need ethics approval?
Ensure research adheres to ethical principles Protects patients Protects researchers Minimises negligence claims Keeps integrity of profession Legal Publication.funding
Who is approval needed from?
NHS - if used patient data or facilities
Uni faculty/research ethics committee
What do RECs consider when looking at an application?
- Purpose and scientific/ethical important
- Potential risks
- Consent procedure
- Vulnerable groups involved
- Method of recruitment
- Use of patient info sheet
- Storage procedure/confidentiality
- Likelihood of achieving aims
Process of EBDM =
- Answerable question
- Search
- Critical appraisal
- Make a decision: evidence, resources, patient preference, clinical experience
PICO =
Patient, problem, population
Intervention
Control, comparator, comparison
Outcome
When you have a factor you cannot control, what type of question do you use?
PEO
PEO =
Patient
Exposure
Outcome
Study for diagnosis question =
Cross-sectional study
Study of aetiology question:
Cohort
Case-control
Study for prognosis question:
Cohort study
Study for treatment question:
RCT
Study for evaluation question:
Qualitative research
Systematic reviews =
Type of literature review that uses systematic methods to collect secondary data, critically appraise and synthesise studies.
Benefits of SR over individual primary studies =
Include all avaliable evidence
Research that is unpublished/not in English language journals
- Increases total sample size
- Meta analysis
- Indicate variation among studies
- Permit subgroup and sensitivity analysis
Subgroup analysis =
Evaluation of treatment effects for a specific end point in subgroups of patients defined by baseline characteristics
Sensitivity analysis =
Asks whether results are sensitive to quality of the research (e.g. what happens if we only look at 10 strongest trials)
Error =
Difference between average values in study population and average values in true population
Bias =
Systematic introduction of error into a study that can distort the results in a non-random way
We should assess a research study for:
Bias
Limitations
Values
Applicability
3 discrete questions when assessing study results:
Are the results valid
What are they
Can I apply them to my patient?
Validity =
Do the results represent an unbiased estimate of the treatment effect or have they been distorted in a systematic fashion to lead to a false conclusion
How might results be presented in an RCT?
Report relative risk reductions, absolute risk reduction, odds ratio, NNT (numbers needed to treat), confidence intervals
Relative risk reductions =
relative decrease in the risk of an adverse event in the exposed group compared to an unexposed group.
NNT =
number of patients you need to treat to prevent one additional bad outcome
How might results be presented in a study looking at diagnosis?
Sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios, confidence intervals
How might results be presented in a study looking at prognosis?
Report how likely the outcomes are over time and how precise the prognostic estimates are (relative risks or odds ratios), confidence intervals
How might results be presented in a study looking at aetiology?
• Harm/aetiology
Report relative risk, odds ratio, NNH (numbers needed to harm), confidence interval
NNH =
indicated how many persons on average need to be exposed to a risk factor over a specific period to cause harm in an average of one person who would not otherwise have been harmed.
What makes a study generalisable/particularisable
Population similar to patient
Resources/service
Cost, risks
What provides the frame work to empower and protect people who may lack capacity to make decisions for themselves?
Mental capacity act (2005)
5 Statutory principles of the mental capacity act:
- Presumption of capacity
- Right to be supported to make own decision
- Right to make eccentric or unwise decisions
- Anything done on behalf of patient must be in best interest
- Least restrictive interventions
How might you determine a patient’s best interest?
Advance statement of wishes
Look at previous decisions
Talk to family
Least restrictive option possible
Criteria for mental capacity =
Understand
Retain
Use/weigh up
Communicate decision
Capacity is specific to what?
The time
The task
What does ‘ability to understand’ mean
Patient must not be able to understand, not sufficient that they don’t understand (this may just be communication)
Considerations for patients ability to use/weigh up
Importance is that they can, should not be based on how the information is weighed up
How is a doctor to make a decision when a patient is deemed to lack capacity?
Advanced decision/directive
Best interest
Least restrictive possible
2 types of advanced care planning
Advanced statement of wishes
Advanced decision/declaration
Which type of advanced care planning is legally binding?
Advanced directive/decisions
Advanced directives are specific to (wishes of treatment/refusal of treatment)
Refusal of treatment
An AD is legally binding if:
Applicable to that circumstance
>18
Informed, specific
Refusal to life saving treatment must be
Written, signed, witnessed
Pros of ADs
Encourage openness and forward planning
Patient autonomy
Reduces anxiety about unwanted treatment
Legal right to refuse treatment
What can patient’s not refuse?
Basic care
Cons of ADs
Difficulties varifying whether opinion has changed
Ascertaining circumstances are what patient forsaw
Can patients ever truely be informed?
Coercion
If a person lacking capacity is very happy why should an AD apply?
Dworkin - experiential vs critical interests.
ADs preserve critical
Experiential interests =
First hand experiences
Critical interests =
Across time, values, the kind of life we want to live
Why might some say an AD shouldn’t be resepected for someone who undergoes severe personality changes?
Personal identity argument - numerically different due to changes psychologies.
Why should practice be research informed?
- Personal experience is bias
- Medical knowledge is incomplete
- Research involves application of the scientific method
- Recommendations assessed for cost/clinical effectiveness
- Standardise care
Describe the research cycle:
Clinical problem - basic research - applied research - clinical care
Clinical problems can be:
Observational
Association
Prognosis
What can we use to decide whether a clinical problem is important for research?
Priority setting partnerships - identify problems by doctors/public
Ex of a priority setting partnership
James Lind Alliance
2 practice gaps identified:
- From bench to bedside - going from basic research into cinical trials
- Implementation gap - from trial to clinical practice/policy
What can help with the gap between basic and clinical research
MRC - medical research council
What may help in gap between research and practice?
NICE
Characteristics of what may make barrier to uptake of evidence?
Recommendation
Adopters
Organisational/structural
Recommendation characteristics which may be barrier to uptake =
Complex
Requires new skill
Doesn’t fit with existing norms
Recommendation characteristics which may facilitate uptake:
Simple/easy to understand
Fit with existing norms/values
Adopter characteristics which may be barrier to uptake:
Knowledge - lack of knowledge, too many guidelines
Attitudes - percieved patient resistance, doubt credibility, reliance on trusted sources
Skills and abilities
Organisational characteristics which may be barrier to uptake:
Limitations: time, resources
Culture: behaviourm norms
Social norms: team norms
What may help change social norms in an organisation?
Opinion makers/influential team leaders
What can help get evidence into practive:
Quality improvement
QI aims to:
facilitate the uptake and continued use of evidence-based policy.
QI should be:
Interactive Involve all Empower staff Foster a culture of change Provide knowledge Remove barriers
QI initiatives targeting organisations:
Revision of professional roles MDT Skill mix Setting of delivery Financial incentives
QI initiatives targeting health care professionals:
Education Outreach visits Local opinion leaders Reminders Multi-factoral
Name 2 financial incentives for QI
CQUIN
QOF
CQUIN =
Commissioning for quality and innovation
What does CQUIN do?
Links a proportion of providers incomes to QI initiatives/achievement of goals
Example of CQUIN initiatives:
Reduce impact of serious infection
Improve staff wellbeing
Reduce disease from risky behaviours
QOF =
Quality and outcomes framework
QOFs target
GP
Do QOFs work: yes
When removed, improvements stable
Drawback of QOFs
Small detrimental effects on aspects not incentivised
Most common policy to manage waiting lists =
Some form of maximum wait
Current maximum wait in England
18 weeks
Current maximum wait in Denmark
4 weeks
Implementation of maximum wait can differ:
- Target and sanctions
- Choice, competition, private sector
- Prioritisation
Countries which implement target and sanctions
England
Finland
Countries which implement choice and competition
Denmark
Netherlands
Portugal
Countries which implement prioritisation
Australia
New Zealand
Canada
England 2000-2005
Maximum wait time guarantee
Penalty: higher chance of hospital managers losing job
What might penalties cause:
Fraud
Misprioritisation of patients
Counter intuitive
Mis-prioritisation of patients =
Once the target has passed, no incentive to treat patient proptly and probablity of being seen decreases
NHS constitiution (2010) patient entiltlements:
Right to access care within max waiting time (18 weeks)
DoH expects what % of patients to be treated in target
90%
Breach of targets in England can result in what
Up to 5% reduction in that specialties funding for month of breach
Management of waiting lists in Denmark =
4 week wait regardless of disease
If hospital cannot fulfil max. wait, can go to another private or public at the expense of region
DRG tariff - profitable to keep patients in country
New Zealand system:
Booking:
- Booked, treated within 6 months
- Certainty of treatment within 6 months
- Active care, review - sent back to GP
In NZ, patients waiting time depends on
Need
Ability to benefit from specialist
What helps Canada and NZ assess need?
Priortisation tools
Prioritisation tools can be
Expensive to develop
Prioritistation tools help
Rules be applied in a consistent way
Australia prioritisation of patients:
3 urgency groups;
(1) Less than 30 days deteriorate quickly, may become an emergency
(2) Less than 90 days some pain, not likely to become emergency
(3) Less than 365 days minimal or no pain, does not have the potential to become an emergency
Norway prioritisation f patients:
(!) Emergency
(2) Elective with individual maximum waiting time
(3) Elective without maximum waiting time
Unconditional wait guarantees are
Easy to operate
Contradict proritisation
Conditional wait guarantees are
Difficult to operationalise
Do not contradict prioritisation
Confounding =
when a relationship between exposure and outcome is distorted by their shared relationship with something else
A confounder may:
Increase apparent relationship
Decrease apparent relationship
A variable is not a confounder if -
No association with exposure
No association with outcome
On the causal pathway between outcome and exposure
Which type of studies are most subject to confounding?
Observational studies: cohort, case-control
RR >1
Risk higher in exposed group
RR <1
Risk lower in exposured group
RR = 1
Risk the same in both groups
Risk differnece +ve
Risk higher in exposed
Risk difference -ve
Risk lower in exposed
4 ways to reduce confounding
Restriction
Matching
Stratification
Multiple variable regression
Restriction and matching are a feature of
Design
Stratification and multiple variable regression are a feature of
Analysis
Restriction =
Limiting sample group to eliminate confounding
Problems with restriction =
Less data collected/greater study needed for same amount
Wasteful
Difficult when you have many confounders
Matching is most commonly used in what type of study
Case-control
Matching is good for
Strong confounders (age, sex)
Problems with matching =
Still need to consider confounding in analysis
Not on its own an answer to confounding
Stratification =
Analyse exposure-outcome relationship in sub-groups associated with confounder. Adjust for confounder
Adjustment gives a
Weighted average of the effect seen in each stratum
Limits of stratification -
Eventually run out of data to fill strata
in y=a+bx b is the
gradient/regression coefficient
in y=a+bx a is the
Y-intercept
Multiple regression coefficent, like stratification allows for
Adjustment